Copyright B 2015 Wolters Kluwer Health, Inc. All rights reserved.
Lucy Lewis, BSc (Health Sciences), RM, MN, PhD Anne M. Williams, RN, BSc (Hons), MSc, PhD Mariyam Athifa, BSc, RN, MHSM Deborah Brown, RN, Dip Palliative Care Charley A. Budgeon, BSc, (Hons. Applied Statistics) Alexandra P. Bremner, BSc, (Hons), DipEd, GradDipAppStats, PhD
Evidence-Based Self-care Guidelines for People Receiving Chemotherapy Do They Reduce Symptom Burden and Psychological Distress?
K E Y
W O R D S
Background: Despite numerous evidence-based guidelines (EBGs) being developed
Chemotherapy
to manage the symptom burden associated with cancer and chemotherapy, there is
Evidence based guidelines
a paucity of research exploring their efficacy. Objective: The aim of this study was to
Symptom burden
explore the effect of implementing EBGs to reduce the symptom burden and psychological distress of cancer patients requiring outpatient chemotherapy at an acute, tertiary care public hospital in Western Australia. Methods: The study was conducted in 2 populations and stages, using action research to promote change. Stage 1 assessed prevalence; in stage 2, specific EBGs were implemented. Symptom prevalence, severity, and bother were determined at baseline and 1 week and 1 month after initial chemotherapy, to allow comparison between stages. Results: Stage 2 participants did better at managing feeling low (odds ratio, 2.33; 95% confidence interval, 1.47Y3.70; P G .001) and vomiting (odds ratio, 2.37; 95% confidence interval, 1.13Y4.97; P = .022). Bother was greater in stage 2 at baseline for vomiting (P = .040), pain (P = .017), feeling tired (P = .038), feeling anxious or worried (P = .001), and feeling low (P = .024). By 1 month, only feeling anxious or worried (P = .023) and feeling low (P = .006) differed. Severity was greater in stage 2 at baseline for pain (P = .025) and feeling anxious or worried (P = .008). By 1 month, only feeling anxious or worried (P = .010) differed. Conclusion: Effective self-care strategies to manage the adverse effects of
Author Affiliations: School of Nursing and Midwifery, Curtin University, Perth (Dr Lewis); Centre for Nursing Research (Drs Lewis and Williams and Ms Athifa), Medical Oncology (Ms Brown), and Department of Research (Ms Budgeon), Sir Charles Gairdner Hospital, Nedlands; School of Nursing and Midwifery, Edith Cowan University, Joondalup (Dr Williams); Centre for Applied Statistics (Ms Budgeon) and School of Population Health (Dr Bremner), The University of Western Australia, Crawley.
The authors have no funding or conflicts of interest to disclose. Correspondence: Lucy Lewis, BSc (Health Sciences), RM, MN, PhD, School of Nursing and Midwifery, Curtin University, Kent Street, Bentley, Perth, Western Australia 6102 ([email protected]). Accepted for publication March 1, 2014. DOI: 10.1097/NCC.0000000000000154
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chemotherapy should be evidence based but individualized, as our findings suggest; for some, focusing on their symptoms may not always be beneficial. Implications for Practice: Providing patients with pathways to information as needed may be preferable to administering multiple EBGs.
E
vidence-based guidelines (EBGs) are systematically developed protocols that are intended to help healthcare practitioners and patients make appropriate decisions in relation to specific clinical circumstances. The use of EBGs has the capacity to increase the proportion of patients to whom current best treatment is offered.1 The implementation of EBGs can be demanding as it requires planning and the participation of the key stakeholders to effect change.2 Organizational barriers to change often need to be addressed, including changes in the organization of care, improvements in continuing education, and interventions to improve quality among healthcare providers.3 The increasing availability of effective ambulatory treatments and the need to justify the cost effectiveness of healthcare have led to more self-care.4 Evidence-based guidelines have the potential to offer patients access to accurate summaries of the best available evidence. Access to these guidelines is rapidly improving, especially through the Internet, enabling a reduction in the traditional delay between the generation of evidence and its application. This has the potential to increase the proportion of patients to whom current best treatment is offered.3 It has been claimed that two-thirds of cancer patients in Australia report unmet supportive needs in relation to their cancer before treatment.5 There is little doubt that patients need to be informed about effective self-care strategies to manage the adverse effects of their chemotherapy treatment. This advice needs to be based on evidence4,6,7 and be individualized,8 as it is not uncommon for patients of the same age, gender, cancer diagnosis, prognosis, and treatment to have different informational requirements. Numerous guidelines have been developed in relation to managing the symptom burden associated with cancer and chemotherapy.9Y11 However, there is a paucity of published studies that specifically explore the value of implementing EBGs to reduce the symptom burden that chemotherapy patients experience.
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Cancer and Symptom Burden
The physical symptoms of cancer tend to occur in clusters.12Y14 Symptoms such as pain are generally associated with the cancer or its treatment, whereas those such as nausea and vomiting are associated mainly with the toxicity of the treatment. Individuals can also experience concurrent comorbid medical conditions12,15,16 with their cancer diagnosis. The term symptom burden is used clinically to describe the combination of multiple symptoms that distress cancer patients, impairing their ability to function normally.12 Symptoms often do not follow the same trajectories, although certain symptoms occur together and may exacerbate another, such as nausea or vomiting. It has been observed that specific symptoms (pain, fatigue, inability to concentrate and sleep) are
likely to be experienced by those being treated for cancer.12 Persistent unrelieved symptoms are distressing and have a negative impact on quality on life,17 with increased symptom burden associated with psychological distress.13
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Cancer and Psychological Distress
Psychological distress is a condition that includes unpleasant emotional and physical symptoms that vary in duration and intensity. The main mood disorders reported by cancer patients are anxiety and depression.14,18,19 Although it is assumed that these symptoms are experienced by a large number of patients, there is a paucity of research exploring these issues in a prechemotherapy setting, especially in a mixed cancer population. The few studies that have researched these psychological disorders in this setting have found the prevalence of anxiety to be 45%14 and the prevalence of depression to be between 25%14 and 27%.20 However, when depression and anxiety were defined by interview, a recent meta-analysis of 94 studies found their prevalence to be less common.21 An estimated two-thirds of cancer patients with depression also experience anxiety.22 Although these 2 forms of psychological distress are often associated with each other and there is a wealth of literature in relation to these topics, surprisingly little is known about the comorbidity of these psychological symptoms.22 There are limited data on changes in anxiety and depression across time. What is known is that anxiety can be mild, moderate, or severe and fluctuates throughout the course of an individual’s cancer treatment, peaking at various points, such as just after learning about one’s cancer diagnosis.18 Poorly controlled anxiety has a negative effect on coping strategies and can drive fear.18 Depression also ranges in severity but is of greater clinical concern because irrelevant of its severity, it affects an individual’s quality of life and general well-being.20,23 Poorly controlled depression can lead to feelings of worthlessness, marked distress, and at its worst, suicidal idealization or suicide.23 Treatment of anxiety and depression is often hindered as only an estimated 36% patients are willing to ask for or accept help.24
Use of EBGs for People Receiving Chemotherapy
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Despite advances in chemotherapy as a treatment for cancer, unrelieved physical and psychological symptoms are common.14 The pre-existing psychosocial factors that individuals bring to their cancer diagnosis may affect how they initially adapt to their prognosis.25 Indeed, studies that have investigated prechemotherapy symptoms have found that before commencing
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chemotherapy, many cancer patients are already experiencing physical and psychological symptoms.14,20,26 Research exploring the informational needs of cancer patients suggests that most patients want to be informed about the symptoms associated with their treatment.27 The response of clinicians to an individual’s symptoms is often hindered by poor communication between patient and clinician.27 Research has also found that nurses who administer chemotherapy may have problems assessing less visible symptoms such as nausea,28 especially if they lack access to appropriate tools designed to routinely detect and monitor this common toxicity.28 Evidence-based guidelines are an option that can be used to help reinforce options for care. A recent Australian study explored why only half those with cancer pain received adequate treatment despite the availability of EBGs. The study used an online survey of 76 oncologists to assess barriers to the utilization of EBGs. It found low usage of guidelines despite support for new Australian EBGs; the authors suggested that this was because of the belief that EBGs were useful for those less competent than themselves.29 Other barriers identified were lack of access or awareness of guidelines. The authors suggested that barriers should be tackled through numerous strategies including a national clinical pathway.29 Clinical audit has also been shown to assist with the integration of EBG at a local clinical level30 as it often employs ongoing staff education and sustained feedback. In this study, self-care guidelines for 5 specific symptoms of chemotherapy were developed, introduced, and evaluated. We hypothesized that cancer patients about to undergo outpatient chemotherapy who received specific EBGs would experience less symptom burden and, therefore, less psychological distress. The aim of this research was to explore the feasibility and the effect of implementing specific EBGs to reduce the symptom burden and, therefore, the psychological distress of cancer patients who require outpatient chemotherapy at an acute tertiary care public hospital in Western Australia.
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Methods
The study took place between July 2010 and November 2011 at Sir Charles Gairdner Hospital, the state referral hospital for cancer patients in Western Australia. The chemotherapy outpatient department at this hospital cares for an average of 15 new patients a week. The study was approved by the hospital’s ethics committee. Action research was selected as an appropriate method for this study as it works with individuals to educate and empower them, by bringing about change through a cyclical process that incorporates action and reflection.31 It has previously been used to successfully implement changes into healthcare practice.31,32 This research describes the first part of the cyclical process where the problem was defined and action was taken by refining and developing the EBGs. The EBGs were then implemented and reflected upon by assessing their impact. The study was conducted in 2 stages, in 2 different populations of cancer patients. In stage 1, the prevalence of symptom
burden and psychological distress associated with chemotherapy was determined using a validated instrument.33 Between stages 1 and 2, an EBG steering group was established, led by a nurse researcher, to drive change.34 The focus of this group was to choose and refine the EBGs for use in stage 2. It was decided that EBGs would be developed for nausea and vomiting, mouth care, diarrhea, constipation, and tiredness. These EBGs were selected as they dealt with common symptoms experienced by patients undergoing chemotherapy.33 The initial templates used to develop these guidelines were sourced from the Chemotherapy Practice Manual from Joanna Briggs Institute,9 patient information sheets from Cancer Care Nova Scotia,10 and the Cancer Council, Victoria.11 The steering group worked with the nurses in the outpatient chemotherapy unit over 4 weeks and aimed to solve the problems encountered with using the EBGs. The EBGs were subsequently piloted with 10 patients in outpatient chemotherapy and further refined following their feedback. When the final EBGs were ready for use, an education program was performed for nurses in the chemotherapy day unit to ensure that they provided patients in stage 2 with consistent information about specific EBGs for the self-management of their chemotherapy-related symptoms. The final EBGs were put together in an A3-sized booklet. In the second stage of the project, immediately after recruitment, each participant was given the EBGs by the research nurse, who explained the content and layout of the EBGs. The prevalence of symptom burden and psychological distress associated with chemotherapy was determined using the same validated instrument used in stage 1.33 The measures from stage 1 and 2 were used to determine the differences between the symptom burden and psychological distress experienced before and after the introduction of the EBGs.
Assessment of Symptom Burden and Psychological Distress The Chemotherapy Symptom Assessment Scale (C-SAS) is a self-report instrument that assesses symptom incidence, symptom severity, and symptom bother. It has specifically been designed for common cancer symptoms in outpatient facilities.33 The main advantage of the C-SAS is that it provides a patientcentered account of symptom experiences. The C-SAS shows acceptable levels of validity and reliability, having a Cronbach’s ! score of .75.33 It has been used previously in an Australian cancer population to measure the prevalence, severity, bother, and distress from physical symptoms and the prevalence of anxiety and depression in patients about to undergo chemotherapy.14 The C-SAS was administered over the telephone by a nurse who was not involved in the participant’s clinical care. Data were collected on the telephone using the C-SAS at 3 points (2 days before commencing chemotherapy and 1 week and 1 month after their initial chemotherapy session) in stage 1 (baseline) as well as stage 2 (after introduction of EBGs). Although the C-SAS assesses a number of symptoms, only those for the 5 EBGs and the additional symptoms of pain, feeling anxious or worried, and feeling low were used for this analysis. At baseline, additional demographic data were collected (such as
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age and type of cancer). In stage 2, the 1-month questionnaire had additional questions about the content of the EBGs (including assessment of whether the EBGs met their needs and were easy to understand and use).
Participants Participants were eligible to participate if they were receiving chemotherapy for the first time, were an outpatient and had cancer, were 18 years or older, and could communicate and read in English. Recruitment was performed before the prechemotherapy education session held 1 week before their first outpatient chemotherapy session. All eligible participants were given a written and verbal explanation of the study by a research nurse. Once verbal consent was gained, the participant was asked to sign a consent form and was given a copy.
Statistics We aimed to recruit 120 patients in stage 1 and 120 patients in stage 2, which would provide 80% power to detect a 50% relative reduction in the proportion of patients experiencing psychological distress at the 5% significance level. IBM SPSS statistical software (version 20)35 was used for data analysis, with significance set to 5%. Two-sided P values are reported. Continuous data (such as age) were summarized using medians and interquartile ranges. The degree of severity and bother of symptoms were compared between stages using nonparametric Mann-Whitney U tests to determine whether the degree of severity and bother of each symptom changed between baseline and 1 week and baseline and 1 month in the patients who experienced the symptom at both time points. In addition, a generalized estimating equation analysis was performed as it takes into account the fact that observations within a subject are correlated and estimates the population average across time. Longitudinal predictors for psychosocial variables, such as being anxious, feeling low, and feeling unusually tired, were considered in addition to physical variables such as nausea, vomiting, and pain. In the generalized estimating equation models, follow-up time occurred at 3 time points: baseline and 1 week and 1 month after chemotherapy treatment. Odds ratios (ORs) and 95% confidence intervals (CIs) comparing the odds of experiencing each symptom are presented for each baseline and time-varying predictor variable found to be significant in the multivariable model.
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Results
Of the 333 patients approached about the study, 290 (87%) participants were recruited, with equal numbers (n = 145) recruited in each of the 2 stages. Of the recruited patients, 12% (34/290) withdrew before completion, with an equal number of patients withdrawing in stage 1 and 2. A total of 5% (14/290) of patients withdrew before commencing the study when the first telephone contact was made at baseline (2 days before commenc-
ing chemotherapy), 3% (8/290) withdrew 1 week after their initial chemotherapy session, and 4% (12/290) withdrew 1 month after their initial chemotherapy session. Reasons for withdrawal included death, being too stressed or anxious by their prognosis to continue with the study, deciding to cancel their chemotherapy, and being too ill to continue with their chemotherapy. The mean (SD) age of participants overall was 61 (12.5) years; those in stage 1 had a mean (SD) age of 60 (12.9) years, whereas those in stage 2 were older, with a mean (SD) age of 62 (12.0) years. Of the 276 participants who commenced the study, 58% (159/276) were women and 42% (117/276) were men. There were more women than men in stage 1 (53%, 73/138) and stage 2 (62%, 86/138). The 3 most prevalent types of cancer experienced were breast (23%, 63/276), gastrointestinal (22%, 61/276), and lung (22%, 60/276). Most (84%, 232/276) participants were prescribed combined chemotherapy medication, with platinumbased chemotherapy being most common (42%, 115/276). Compared with those in stage 1, patients in stage 2 were more likely to experience 4 or more symptoms (OR, 1.82; 95% CI, 1.12Y2.96; P = .015) and be more anxious or worried at baseline (73% vs 50%; P G .001). Before commencing chemotherapy, patients were already experiencing psychological and physical symptoms. Psychological symptoms included feeling anxious or worried (65%, 178/276) and unusually tired (60%, 166/276). Physical symptoms included pain (55%, 152/276) and constipation (28%, 78/276) (Table 1). The symptoms of feeling anxious or worried, tired, and pain were significantly higher in prevalence in stage 2 to stage 1. In multivariable analysis, there were 3 symptoms for which the interaction between stage and time was significant: feeling low, vomiting, and problems with the mouth and throat. Participants in stage 2 did not experience any change in feeling low across time, but those in stage 1 were found to be more likely to feel low, when monthly rates were compared with baseline rates (OR, 2.33; 95% CI, 1.47Y3.70; P G .001). In stage 2, participants did not experience any change in vomiting across time. However, participants in stage 1 were found to have increased vomiting when week 1 was compared with baseline (OR, 2.40; 95% CI, 1.14Y5.06; P = .021) and 1 month was compared with baseline (OR, 2.37; 95% CI, 1.13Y4.97; P = .022). Problems with mouth and throat increased across time irrelevant of stage (Table 2). The severity of most symptoms did not differ significantly between the stages of the study. Exceptions were the severity of pain (P = .025) and feeling anxious or worried (P = .008) at baseline; pain (P = .030), feeling anxious or worried (P = .047), and feeling low (P = .028) at 1 week after initial chemotherapy treatment; and pain (P = .045) and feeling anxious or worried (P = .010) at 1 month after initial chemotherapy treatment. Participants who experienced these symptoms reported a greater degree of severity in stage 2. Compared with stage 1, bother was greater in stage 2 at baseline for vomiting (P = .040), pain (P = .017), feeling tired (P = .038), feeling anxious or worried (P = .001), and feeling low (P = .024). However, by 1 week, the degree of bother differed significantly only for pain (P = .008) and feeling low (P = .002). By 1 month, only feeling anxious or worried (P = .023) and feeling low (P = .006) differed significantly. Participants who
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Table 1 & Prevalence, Severity, and Bother of Symptoms for Stages 1 and 2 Combined Prevalence
Severity
Bother
Variable
Baseline
Weekly
Monthly
Baseline
Weekly
Monthly
Baseline
Weekly
Monthly
Nausea Vomiting Constipation Diarrhea Problems with mouth/throat Unusually tired Pain Feeling anxious or worried Feeling Low
56 33 78 37 52 166 152 178 85
138 38 154 66 120 197 128 83 90
120 (47) 34 (13) 118 (46) 71 (28) 123 (48) 188 (73) 123 (48) 87 (34) 102 (40)
25 (45) 20 (61) 57 (67) 9 (24) 20 (38) 107 (64) 89 (59) 105 (59) 50 (59)
58 21 88 30 45 121 76 57 52
66 22 75 40 64 138 72 53 60
21 21 35 5 29 92 70 130 61
52 14 70 17 34 62 59 48 37
59 22 58 30 37 91 58 47 56
(20) (12) (28) (13) (19) (60) (55) (65) (31)
(51) (14) (57) (43) (45) (74) (48) (31) (34)
(42) (55) (57) (45) (38) (61) (59) (69) (58)
(55) (65) (64) (56) (52) (73) (59) (61) (59)
(38) (64) (45) (14) (56) (55) (46) (73) (72)
(38) (37) (80) (26) (28) (31) (46) (58) (41)
(49) (65) (49) (42) (30) (48) (47) (54) (55)
Data are presented as n (%). Baseline data concern data collected before commencing chemotherapy. Weekly and monthly data concern data collected at 1 week and 1 month after initial chemotherapy treatment, respectively. The frequencies of those who experienced severity and bother are calculated from the prevalence of those experiencing the symptom at the correlating time (baseline, weekly, and monthly time points). Severity is recorded from those with moderate or severe severity. Bother is recorded for those with quite a bit or very much bother.
experienced these symptoms reported a greater degree of bother in stage 2. A number of participants (31%, 39/128) did not use the EBGs. The main reasons for not using the EBGs included being given too much information, deciding to find their own information on the Internet, being too stressed by potential symptoms to read about them, and misplacing the EBGs. Of the 70% (89/128) who read the guidelines, most (96%, 85 of 89) perceived that the guidelines met their needs. The main reasons given for this perception were that they were well laid out, clear, easy to read, and straightforward.
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Discussion
Baseline
which may have exacerbated this symptom. However, research in relation to coping with symptom burden has not identified a clear anxiety trajectory. Anxiety often peaks before treatment, but it can also peak at different times during an individual’s cancer journey.18 Those receiving chemotherapy for cancer often have personalized methods for coping with anxiety, which may include positive strategies such as problem solving or negative strategies such as avoidance.38 Participants in stage 2 received their chemotherapy in conjunction with major changes within the hospital’s infrastructure, both in terms of staffing and moving the cancer center to a new site. Although we have no evidence to link these factors to the increased number of symptoms experienced and the anxiety and worry that stage 2 participants experienced at baseline, the impact of the hospital environment cannot be ignored.
Symptom Trajectories 14,20,26
This study reinforces the findings of others that before commencing chemotherapy, many patients are already experiencing psychological and physical symptoms associated with their cancer. Compared with those in stage 1, stage 2 participants were more likely to experience 4 or more symptoms (P = .015) at baseline. Although others have found that cancer patients experience numerous symptoms before commencing chemotherapy,12,14,16 establishing a reason for the baseline symptom difference between the 2 cohorts was difficult as they were similar in terms of age, sex, gender, and cancer diagnosis. Another explanation for the baseline differences could be that exposure to the EBGs encouraged those in stage 2 to focus on their symptoms. Previous research has found that patients’ expectations of the symptoms they experience may have a negative impact on their quality of life during chemotherapy.36 This may help to explain why those in stage 2 experienced significantly more anxiety and worry. In addition, increased symptom burden has been found by others to be linked to anxiety,18,33,37
Despite being at a disadvantage at baseline (in terms of increased likelihood of feeling anxious or worried and number of symptoms), participants in stage 2 did better at managing feeling low and vomiting, whereas problems with mouth and throat increased across time irrelevant of stage. Depression and anxiety are consistently found to coexist.39 In multivariable analysis, no differences were found between stages in relation to anxiety and worry. However, participants in stage 2 were more likely than those in stage 1 to experience and report a greater degree of severity and bother. Depression is consistently associated with chemotherapy in patients.14,20 This study appeared to have a positive impact on the rates of feeing low, as only stage 1 participants experienced increased rates of feeling low. It is possible that participants in stage 2 derived psychological benefit from the extra time spent on the telephone (as a result of the additional questions in relation to the EBGs) with a nurse not involved in their care. Research has found that information and provision of support from
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Table 2 & Unadjusted and Adjusted Results of Symptoms Where an Interaction Between Stage and Time Was Significant
Univariate
Feeling low Age Female vs male Stage 2 vs stage 1 Time Weekly vs baseline Monthly vs baseline Monthly vs baseline Time Stage 1 weekly vs baseline Stage 2 weekly vs baseline Stage 1 monthly vs baseline Stage 2 monthly vs baseline Vomit Age Female vs Male Stage 2 vs stage 1 Time Weekly vs baseline Monthly vs baseline Monthly vs baseline Time Stage 1 weekly vs baseline Stage 2 weekly vs baseline Stage 1 monthly vs baseline Stage 2 monthly vs baseline Problems with mouth and throat Age Female vs male Stage 2 vs stage 1 Time Weekly vs baseline Monthly vs baseline Monthly vs baseline Time Stage 1 weekly vs baseline Stage 2 weekly vs baseline Stage 1 monthly vs baseline Stage 2 monthly vs baseline
Multivariate
OR (95% CI)
OR (95% CI)
P
0.98 (0.96Y0.99) 0.99 (0.68Y1.43) 0.98 (0.68Y1.42)
0.98 (0.96Y0.99)
.004 N/S .050
1.14 (0.85Y1.51) 1.49 (1.07Y2.06) 1.31 (1.00Y1.72)
.002
1.51 0.88 2.33 0.99
(0.99Y2.31) (0.58Y1.31) (1.47Y3.70) (0.61Y1.59)
.06 .519 G.001 .954
0.98 (0.96Y1.00) 1.05 (0.63Y1.76) 1.06 (0.64Y1.76)
N/S N/S .740
1.22 (0.79Y1.88) 1.13 (0.72Y1.78) 0.93 (0.62Y1.39)
.489
2.40 0.72 2.37 0.61
(1.14Y5.06) (0.42Y1.23) (1.13Y4.97) (0.34Y1.12)
.022 .231 .022 .110
0.99 (0.98Y1.00) 1.18 (0.85Y1.63) 1.17 (0.85Y1.62)
N/S N/S .538
3.49 (2.42Y5.04) 3.95 (2.73Y5.72) 1.13 (0.86Y1.50)
G.001
4.28 2.87 3.29 4.74
(2.52Y7.25) (1.73Y4.77) (1.97Y5.50) (2.77Y8.12)
G.001 G.001 G.001 G.001
Stage is defined as stage 1 or 2. Baseline data concern data collected before commencing chemotherapy. Weekly and monthly data concern data collected at 1 week and 1 month after initial chemotherapy treatment, respectively. Abbreviations: CI, confidence interval; N/S, not significant; OR, odds ratio.
a trusted individual via a telephone assists people with cancer; a recent Cochrane review suggested that nurse-delivered interventions, which include information combined with supportive attention, may have a positive impact on mood in newly diagnosed cancer patients.40 Nausea was experienced by half the participants during their chemotherapy, and although it was apparent that the severity and bother of nausea were troublesome across time, neither were impacted by stage. Participants in stage 1 experienced increased vomiting, whereas those in stage 2 experienced no change. The finding that vomiting can be reduced with an intensive che-
motherapy education program has been described previously41,42 and suggests that focus on this toxicity is productive, especially if it is modified to meet individuals’ needs before commencing chemotherapy.41 Chemotherapy-induced nausea and vomiting are associated with deterioration in quality of life43 being feared by many chemotherapy patients. Practitioners have been found to underestimate the occurrence of nausea and vomiting, particularly delayed symptoms. Research continually points to the need for a standardized assessment tool and management protocol to meet the needs of both chemotherapy staff 37,42 and patients.37,41
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Problems with the mouth and throat increased across time irrelevant of stage, with no significant difference found in severity or bother between stages. Chemotherapy is associated with oral and throat complications, especially oral mucositis, which presents a unique set of challenges because of its complex pathogenesis.44 Although the evidence for basic oral care is supported,44 it has been debated whether basic oral care (used by our EBGs) can interrupt the molecular factors that result in mucosal tissue damage.44 Although evidence is building in this area, there has been a call for improved evidence to guide future clinical care.44 The prevalence of reported pain was high in both stages being present in more than half (55%) the participants at baseline. This is likely to be linked to previous surgery rather than the cancer itself.14 As many treatment options are available at our tertiary cancer center, this finding was disappointing. In our study, participants in stage 2 reported greater severity of pain than did those in stage 1 at baseline (P = .025) and 1 week (P = .030) and 1 month (P = .045) after initial chemotherapy. In addition, participants in stage 2 were more likely than those in stage 1 to find their pain bothersome at baseline (P = .017) and 1 week after initial chemotherapy (P = .008). These findings suggest that encouraging individuals to focus on their symptoms may not always be beneficial. Others have found that despite the availability of EBGs for pain, barriers to integration continue to exist, with suboptimal reassessment processes and lack of documentation contributing toward poor pain management in chemotherapy patients.29,30
Evidence-Based Guidelines Previous research investigating the use of EBGs has highlighted the difficulties related to consistent use of these guidelines in clinical practice.29 Reflections on the patients’ evaluations of the EBGs suggest that a more individually focused approach could be more beneficial. A number of the patients felt overwhelmed by the amount of information given to them. Providing patients with a guiding pathway for access to information as needed may be a preferable approach, especially for the prevalence of psychological symptoms that seem to be associated with increased severity and bother. The development of online information resources for patients undergoing chemotherapy could be considered to address symptom burden and psychological distress as needed. Provision of basic information before commencement of therapies regarding preventative measures and the availability of support and information via the telephone throughout the treatment period could also be considered.
Limitations This study had a number of limitations. First, chemotherapy staff were aware that the EBGs were being implemented and patients’ symptoms were being assessed, and this could have confounded the results. Second, the study was undertaken at a single tertiary referral center and studied only cancer patients who were receiving chemotherapy for the first time. Third, we could consider only patients who spoke English. Fourth, as mentioned
above, patients in stage 2 received their chemotherapy during a time of major change within the cancer unit.
Conclusion It is evident that before commencing chemotherapy, many patients are already experiencing psychological and physical symptoms associated with their cancer. Providing patients with a pathway for access to information as needed may be a preferable approach to giving them multiple EBGs. This is especially important for those who experience psychological symptoms, which seem to be associated with increased severity and bother. Further research incorporating more hospital settings and addressing issues experienced by nonYEnglish speaking patients is needed to build on this work. ACKNOWLEDGMENTS
We would like to acknowledge Ms Dianne Grennan and Ms Cathy Pienaar for their assistance with data collection. We would also like to thank Vivienne Brown for use of the C-SAS.
References 1. Guyatt G, Cook D, Haynes B. Evidence based medicine has come a long way. BMJ. 2004;329(7473):990Y999. 2. Rycroft Malone J. Implementing evidence-based practice in the reality of clinical practice. Worldviews Evid Based Nurse. 2012;9(1):1. 3. Haynes B, Haines A. Barriers and bridges to evidence based clinical practice. BMJ. 1998;317(7153):273Y276. 4. Lotfi-Jam K, Carey M, Jefford M, et al. Nonpharmacologic strategies for managing common chemotherapy adverse effects: a systematic review. J Clin Oncol. 2008;26(34):5618Y5629. 5. McDowell ME, Occhipinti S, Ferguson M, et al. Predictors of change in unmet supportive care needs in cancer. Psychooncology. 2010;19(5):508Y516. 6. Farrington M, Cullen L, Dawson C. Evidence based oral care for oral mucositis. ORL Head Neck Nurs. 2013;31(3):6Y15. 7. McPherson CJ, Higginson IJ, Hearn J. Effective methods of giving information in cancer: a systematic literature review of randomized controlled trials. J Public Health Med. 2001;23(3):227Y234. 8. Mills ME, Sullivan K. The importance of information giving for patients newly diagnosed with cancer: a review of the literature. J Clin Nurse. 1999; 8(6):631Y642. 9. The Joanna Briggs Institute. http://joannabriggs.org/. Accessed September 25, 2013. 10. Cancer Care Nova Scotia. http://www.cancercare.ns.ca/en/home/default.aspx. Accessed September 25, 2013. 11. The Cancer Council of Victoria. http://www.cancervic.org.au/. Accessed September 25, 2013. 12. Cleeland C, Mendoza T, Wang X, et al. Levels of symptom burden during chemotherapy for advanced lung cancer: differences between public hospitals and a tertiary cancer center. J Clin Oncol. 2011;29(21):2859Y2865. 13. Kirkova J, Rybicki L, Walsh D, et al. Symptom prevalence in advanced cancer: age, gender, and performance status interactions. Am J Hosp Palliat Care. 2012;29(2):139Y145. 14. Breen S, Baravelli C, Schofield P, et al. Is symptom burden a predictor of anxiety and depression in patients with cancer about to commence chemotherapy? Med J Aust. 2009;190(Suppl 7):S99YS104. 15. Davis M, Kirkova J. Lifting symptom burdenVhow far off the ground are we? Support Care Cancer. 2008;16(7):757Y761. 16. Kirkova J, Davis M, Walsh D, et al. Cancer symptom assessment instruments: a systematic review. J Clin Oncol. 2006;24(9):1459Y1473.
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17. Agarwal S, Bodurka DC. Symptom research in gynecologic oncology: a review of available measurement tools. Gynecol Oncol. 2010;119(2):384Y389. 18. Traeger L, Greer J, Fernandez Robles C, et al. Evidence-based treatment of anxiety in patients with cancer. J Clinic Oncol. 2012;30(11):1197Y1205. 19. Rayner L, Price A, Hotopf M, et al. The development of evidence-based European guidelines on the management of depression in palliative cancer care. Eur J Cancer. 2011;47(5):702Y712. 20. Wedding U, Koch A, Ro¨hrig B, et al. Depression and functional impairment independently contribute to decreased quality of life in cancer patients prior to chemotherapy. Acta Oncol. 2008;47(1):56Y62. 21. Mitchell AJ, Chan M, Bhatti H, et al. Prevalence of depression, anxiety, and adjustment disorder in oncological, haematological, and palliativecare settings: a meta-analysis of 94 interview-based studies. Lancet Oncol. 2011;12(2):160Y174. 22. Brintzenhofe-Szoc KM, Levin T, Li Y, et al. Mixed anxiety/depression symptoms in a large cancer cohort: prevalence by cancer type. Psychosomatics. 2009;50(4):383Y391. 23. Li M, Fitzgerald P, Rodin G. Evidence-based treatment of depression in patients with cancer. J Clinic Oncol. 2012;30(11):1187Y1196. 24. Baker Glenn E, Park B, Granger L, et al. Desire for psychological support in cancer patients with depression or distress: validation of a simple help question. Psychooncology. 2011;20(5):525Y531. 25. Zabora J, BrintzenhofeSzoc K, Curbow B, et al. The prevalence of psychological distress by cancer site. Psychooncology. 2001;10(1):19Y28. 26. Kangas M, Milross C, Taylor A, et al. A pilot randomized controlled trial of a brief early intervention for reducing posttraumatic stress disorder, anxiety and depressive symptoms in newly diagnosed head and neck cancer patients. Psychooncology. 2013;22(7):1665Y1673. 27. Walling A, Lorenz KA, Dy SM, et al. Evidence-based recommendations for information and care planning in cancer care. J Clin Oncol. 2008;26(23): 3896Y3902. 28. Wood J, Chapman K, Eilers J. Tools for assessing nausea, vomiting and retching. Cancer Nurs. 2011;34(1):E14YE24. 29. Luckett T, Davidson PM, Boyle F, et al. Australian survey of current practice and guideline use in adult cancer pain assessment and management: perspectives of oncologists [published online ahead of print December 17, 2013]. Asia Pac J Clin Oncol. doi:10.1111/ajco.12040. 30. Dulko D, Hertz E, Julien J, et al. Implementation of cancer pain guidelines by acute care nurse practitioners using an audit and feedback strategy. J Am Acad Nurse Pract. 2010;22(1):45Y55. 31. Froggatt K, Hockley J. Action research in palliative care: defining an evaluation methodology. Palliat Med. 2011;25(8):782Y787. 32. Williams A, Toye C, Deas K, et al. Evaluating the feasibility and effect of
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using a hospital-wide coordinated approach to introduce evidence-based changes for pain management. Pain Manag Nurs. 2012;13(4):202Y214. Brown V, Sitzia J, Richardson A, et al. The development of the Chemotherapy Symptom Assessment Scale (C-SAS): a scale for the routine clinical assessment of the symptom experiences of patients receiving cytotoxic chemotherapy. Int J Nurs Stud. 2001;38(5):497Y510. Gallagher L, Truglio Londrigan M, Levin R. Partnership for healthy living: an action research project. Nurse Res. 2009;16(2):7Y29. IBM Corp. IBM SPSS Statistics for Windows, Version 20.0. Armonk, NY: IBM Corp; 2011. Whitford H, Olver I. When expectations predict experience: the influence of psychological factors on chemotherapy toxicities. J Pain Symptom Manage. 2012;43(6):1036Y1050. So WK, Marsh G, Ling WM, et al. The symptom cluster of fatigue, pain, anxiety, and depression and the effect on the quality of life of women receiving treatment for breast cancer: a multicenter study. Oncol Nurs Forum. 2009;36(4):E205YE214. Shapiro J, McCue K, Heyman E, et al. Coping-related variables associated with individual differences in adjustment to cancer. J Psychosoc Oncol. 2010; 28(1):1Y22. Delgado Guay M, Parsons H, Li Z, et al. Symptom distress in advanced cancer patients with anxiety and depression in the palliative care setting. Support Care Cancer. 2009;17(5):573Y579. Galway K, Black A, Cantwell M, et al. Psychosocial interventions to improve quality of life and emotional wellbeing for recently diagnosed cancer patients. Cochrane Database Syst Rev [Internet]. 2012. http://onlinelibrary .wiley.com.qelibresources.health.wa.gov.au/doi/10.1002/14651858 .CD007064.pub2/pdf. Accessed September 10, 2013. Aranda S, Jefford M, Yates P, et al. Impact of a novel nurse-led prechemotherapy education intervention (ChemoEd) on patient distress, symptom burden, and treatment-related information and support needs: results from a randomised, controlled trial. Ann Oncol. 2012;23(1):222Y231. Chung S, Ahn M, Yoo J, et al. Implementation of best practice for chemotherapy-induced nausea and vomiting in an acute care setting. Int J Evid Based Healthc. 2011;9(1):32Y38. Bloechl-Daum B, Deuson R, Mavros P, et al. Delayed nausea and vomiting continue to reduce patients’ quality of life after highly and moderately emetogenic chemotherapy despite antiemetic treatment. J Clin Oncol. 2006; 24(27):4472Y4478. McGuire D, Fulton J, Park J, et al. Systematic review of basic oral care for the management of oral mucositis in cancer patients [published online ahead of print September 10, 2013]. Support Care Cancer. 2013. doi:10 .1007/s.00520-013-1942-0.
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Lucy Lewis, BSc (Health Sciences), RM, MN, PhD Anne M. Williams, RN, BSc (Hons), MSc, PhD Mariyam Athifa, BSc, RN, MHSM Deborah Brown, RN, Dip Palliative Care Charley A. Budgeon, BSc, (Hons. Applied Statistics) Alexandra P. Bremner, BSc, (Hons), DipEd, GradDipAppStats, PhD
Evidence-Based Self-care Guidelines for People Receiving Chemotherapy Do They Reduce Symptom Burden and Psychological Distress?
K E Y
W O R D S
Background: Despite numerous evidence-based guidelines (EBGs) being developed
Chemotherapy
to manage the symptom burden associated with cancer and chemotherapy, there is
Evidence based guidelines
a paucity of research exploring their efficacy. Objective: The aim of this study was to
Symptom burden
explore the effect of implementing EBGs to reduce the symptom burden and psychological distress of cancer patients requiring outpatient chemotherapy at an acute, tertiary care public hospital in Western Australia. Methods: The study was conducted in 2 populations and stages, using action research to promote change. Stage 1 assessed prevalence; in stage 2, specific EBGs were implemented. Symptom prevalence, severity, and bother were determined at baseline and 1 week and 1 month after initial chemotherapy, to allow comparison between stages. Results: Stage 2 participants did better at managing feeling low (odds ratio, 2.33; 95% confidence interval, 1.47Y3.70; P G .001) and vomiting (odds ratio, 2.37; 95% confidence interval, 1.13Y4.97; P = .022). Bother was greater in stage 2 at baseline for vomiting (P = .040), pain (P = .017), feeling tired (P = .038), feeling anxious or worried (P = .001), and feeling low (P = .024). By 1 month, only feeling anxious or worried (P = .023) and feeling low (P = .006) differed. Severity was greater in stage 2 at baseline for pain (P = .025) and feeling anxious or worried (P = .008). By 1 month, only feeling anxious or worried (P = .010) differed. Conclusion: Effective self-care strategies to manage the adverse effects of
Author Affiliations: School of Nursing and Midwifery, Curtin University, Perth (Dr Lewis); Centre for Nursing Research (Drs Lewis and Williams and Ms Athifa), Medical Oncology (Ms Brown), and Department of Research (Ms Budgeon), Sir Charles Gairdner Hospital, Nedlands; School of Nursing and Midwifery, Edith Cowan University, Joondalup (Dr Williams); Centre for Applied Statistics (Ms Budgeon) and School of Population Health (Dr Bremner), The University of Western Australia, Crawley.
The authors have no funding or conflicts of interest to disclose. Correspondence: Lucy Lewis, BSc (Health Sciences), RM, MN, PhD, School of Nursing and Midwifery, Curtin University, Kent Street, Bentley, Perth, Western Australia 6102 ([email protected]). Accepted for publication March 1, 2014. DOI: 10.1097/NCC.0000000000000154
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chemotherapy should be evidence based but individualized, as our findings suggest; for some, focusing on their symptoms may not always be beneficial. Implications for Practice: Providing patients with pathways to information as needed may be preferable to administering multiple EBGs.
E
vidence-based guidelines (EBGs) are systematically developed protocols that are intended to help healthcare practitioners and patients make appropriate decisions in relation to specific clinical circumstances. The use of EBGs has the capacity to increase the proportion of patients to whom current best treatment is offered.1 The implementation of EBGs can be demanding as it requires planning and the participation of the key stakeholders to effect change.2 Organizational barriers to change often need to be addressed, including changes in the organization of care, improvements in continuing education, and interventions to improve quality among healthcare providers.3 The increasing availability of effective ambulatory treatments and the need to justify the cost effectiveness of healthcare have led to more self-care.4 Evidence-based guidelines have the potential to offer patients access to accurate summaries of the best available evidence. Access to these guidelines is rapidly improving, especially through the Internet, enabling a reduction in the traditional delay between the generation of evidence and its application. This has the potential to increase the proportion of patients to whom current best treatment is offered.3 It has been claimed that two-thirds of cancer patients in Australia report unmet supportive needs in relation to their cancer before treatment.5 There is little doubt that patients need to be informed about effective self-care strategies to manage the adverse effects of their chemotherapy treatment. This advice needs to be based on evidence4,6,7 and be individualized,8 as it is not uncommon for patients of the same age, gender, cancer diagnosis, prognosis, and treatment to have different informational requirements. Numerous guidelines have been developed in relation to managing the symptom burden associated with cancer and chemotherapy.9Y11 However, there is a paucity of published studies that specifically explore the value of implementing EBGs to reduce the symptom burden that chemotherapy patients experience.
n
Cancer and Symptom Burden
The physical symptoms of cancer tend to occur in clusters.12Y14 Symptoms such as pain are generally associated with the cancer or its treatment, whereas those such as nausea and vomiting are associated mainly with the toxicity of the treatment. Individuals can also experience concurrent comorbid medical conditions12,15,16 with their cancer diagnosis. The term symptom burden is used clinically to describe the combination of multiple symptoms that distress cancer patients, impairing their ability to function normally.12 Symptoms often do not follow the same trajectories, although certain symptoms occur together and may exacerbate another, such as nausea or vomiting. It has been observed that specific symptoms (pain, fatigue, inability to concentrate and sleep) are
likely to be experienced by those being treated for cancer.12 Persistent unrelieved symptoms are distressing and have a negative impact on quality on life,17 with increased symptom burden associated with psychological distress.13
n
Cancer and Psychological Distress
Psychological distress is a condition that includes unpleasant emotional and physical symptoms that vary in duration and intensity. The main mood disorders reported by cancer patients are anxiety and depression.14,18,19 Although it is assumed that these symptoms are experienced by a large number of patients, there is a paucity of research exploring these issues in a prechemotherapy setting, especially in a mixed cancer population. The few studies that have researched these psychological disorders in this setting have found the prevalence of anxiety to be 45%14 and the prevalence of depression to be between 25%14 and 27%.20 However, when depression and anxiety were defined by interview, a recent meta-analysis of 94 studies found their prevalence to be less common.21 An estimated two-thirds of cancer patients with depression also experience anxiety.22 Although these 2 forms of psychological distress are often associated with each other and there is a wealth of literature in relation to these topics, surprisingly little is known about the comorbidity of these psychological symptoms.22 There are limited data on changes in anxiety and depression across time. What is known is that anxiety can be mild, moderate, or severe and fluctuates throughout the course of an individual’s cancer treatment, peaking at various points, such as just after learning about one’s cancer diagnosis.18 Poorly controlled anxiety has a negative effect on coping strategies and can drive fear.18 Depression also ranges in severity but is of greater clinical concern because irrelevant of its severity, it affects an individual’s quality of life and general well-being.20,23 Poorly controlled depression can lead to feelings of worthlessness, marked distress, and at its worst, suicidal idealization or suicide.23 Treatment of anxiety and depression is often hindered as only an estimated 36% patients are willing to ask for or accept help.24
Use of EBGs for People Receiving Chemotherapy
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Despite advances in chemotherapy as a treatment for cancer, unrelieved physical and psychological symptoms are common.14 The pre-existing psychosocial factors that individuals bring to their cancer diagnosis may affect how they initially adapt to their prognosis.25 Indeed, studies that have investigated prechemotherapy symptoms have found that before commencing
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chemotherapy, many cancer patients are already experiencing physical and psychological symptoms.14,20,26 Research exploring the informational needs of cancer patients suggests that most patients want to be informed about the symptoms associated with their treatment.27 The response of clinicians to an individual’s symptoms is often hindered by poor communication between patient and clinician.27 Research has also found that nurses who administer chemotherapy may have problems assessing less visible symptoms such as nausea,28 especially if they lack access to appropriate tools designed to routinely detect and monitor this common toxicity.28 Evidence-based guidelines are an option that can be used to help reinforce options for care. A recent Australian study explored why only half those with cancer pain received adequate treatment despite the availability of EBGs. The study used an online survey of 76 oncologists to assess barriers to the utilization of EBGs. It found low usage of guidelines despite support for new Australian EBGs; the authors suggested that this was because of the belief that EBGs were useful for those less competent than themselves.29 Other barriers identified were lack of access or awareness of guidelines. The authors suggested that barriers should be tackled through numerous strategies including a national clinical pathway.29 Clinical audit has also been shown to assist with the integration of EBG at a local clinical level30 as it often employs ongoing staff education and sustained feedback. In this study, self-care guidelines for 5 specific symptoms of chemotherapy were developed, introduced, and evaluated. We hypothesized that cancer patients about to undergo outpatient chemotherapy who received specific EBGs would experience less symptom burden and, therefore, less psychological distress. The aim of this research was to explore the feasibility and the effect of implementing specific EBGs to reduce the symptom burden and, therefore, the psychological distress of cancer patients who require outpatient chemotherapy at an acute tertiary care public hospital in Western Australia.
n
Methods
The study took place between July 2010 and November 2011 at Sir Charles Gairdner Hospital, the state referral hospital for cancer patients in Western Australia. The chemotherapy outpatient department at this hospital cares for an average of 15 new patients a week. The study was approved by the hospital’s ethics committee. Action research was selected as an appropriate method for this study as it works with individuals to educate and empower them, by bringing about change through a cyclical process that incorporates action and reflection.31 It has previously been used to successfully implement changes into healthcare practice.31,32 This research describes the first part of the cyclical process where the problem was defined and action was taken by refining and developing the EBGs. The EBGs were then implemented and reflected upon by assessing their impact. The study was conducted in 2 stages, in 2 different populations of cancer patients. In stage 1, the prevalence of symptom
burden and psychological distress associated with chemotherapy was determined using a validated instrument.33 Between stages 1 and 2, an EBG steering group was established, led by a nurse researcher, to drive change.34 The focus of this group was to choose and refine the EBGs for use in stage 2. It was decided that EBGs would be developed for nausea and vomiting, mouth care, diarrhea, constipation, and tiredness. These EBGs were selected as they dealt with common symptoms experienced by patients undergoing chemotherapy.33 The initial templates used to develop these guidelines were sourced from the Chemotherapy Practice Manual from Joanna Briggs Institute,9 patient information sheets from Cancer Care Nova Scotia,10 and the Cancer Council, Victoria.11 The steering group worked with the nurses in the outpatient chemotherapy unit over 4 weeks and aimed to solve the problems encountered with using the EBGs. The EBGs were subsequently piloted with 10 patients in outpatient chemotherapy and further refined following their feedback. When the final EBGs were ready for use, an education program was performed for nurses in the chemotherapy day unit to ensure that they provided patients in stage 2 with consistent information about specific EBGs for the self-management of their chemotherapy-related symptoms. The final EBGs were put together in an A3-sized booklet. In the second stage of the project, immediately after recruitment, each participant was given the EBGs by the research nurse, who explained the content and layout of the EBGs. The prevalence of symptom burden and psychological distress associated with chemotherapy was determined using the same validated instrument used in stage 1.33 The measures from stage 1 and 2 were used to determine the differences between the symptom burden and psychological distress experienced before and after the introduction of the EBGs.
Assessment of Symptom Burden and Psychological Distress The Chemotherapy Symptom Assessment Scale (C-SAS) is a self-report instrument that assesses symptom incidence, symptom severity, and symptom bother. It has specifically been designed for common cancer symptoms in outpatient facilities.33 The main advantage of the C-SAS is that it provides a patientcentered account of symptom experiences. The C-SAS shows acceptable levels of validity and reliability, having a Cronbach’s ! score of .75.33 It has been used previously in an Australian cancer population to measure the prevalence, severity, bother, and distress from physical symptoms and the prevalence of anxiety and depression in patients about to undergo chemotherapy.14 The C-SAS was administered over the telephone by a nurse who was not involved in the participant’s clinical care. Data were collected on the telephone using the C-SAS at 3 points (2 days before commencing chemotherapy and 1 week and 1 month after their initial chemotherapy session) in stage 1 (baseline) as well as stage 2 (after introduction of EBGs). Although the C-SAS assesses a number of symptoms, only those for the 5 EBGs and the additional symptoms of pain, feeling anxious or worried, and feeling low were used for this analysis. At baseline, additional demographic data were collected (such as
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age and type of cancer). In stage 2, the 1-month questionnaire had additional questions about the content of the EBGs (including assessment of whether the EBGs met their needs and were easy to understand and use).
Participants Participants were eligible to participate if they were receiving chemotherapy for the first time, were an outpatient and had cancer, were 18 years or older, and could communicate and read in English. Recruitment was performed before the prechemotherapy education session held 1 week before their first outpatient chemotherapy session. All eligible participants were given a written and verbal explanation of the study by a research nurse. Once verbal consent was gained, the participant was asked to sign a consent form and was given a copy.
Statistics We aimed to recruit 120 patients in stage 1 and 120 patients in stage 2, which would provide 80% power to detect a 50% relative reduction in the proportion of patients experiencing psychological distress at the 5% significance level. IBM SPSS statistical software (version 20)35 was used for data analysis, with significance set to 5%. Two-sided P values are reported. Continuous data (such as age) were summarized using medians and interquartile ranges. The degree of severity and bother of symptoms were compared between stages using nonparametric Mann-Whitney U tests to determine whether the degree of severity and bother of each symptom changed between baseline and 1 week and baseline and 1 month in the patients who experienced the symptom at both time points. In addition, a generalized estimating equation analysis was performed as it takes into account the fact that observations within a subject are correlated and estimates the population average across time. Longitudinal predictors for psychosocial variables, such as being anxious, feeling low, and feeling unusually tired, were considered in addition to physical variables such as nausea, vomiting, and pain. In the generalized estimating equation models, follow-up time occurred at 3 time points: baseline and 1 week and 1 month after chemotherapy treatment. Odds ratios (ORs) and 95% confidence intervals (CIs) comparing the odds of experiencing each symptom are presented for each baseline and time-varying predictor variable found to be significant in the multivariable model.
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Results
Of the 333 patients approached about the study, 290 (87%) participants were recruited, with equal numbers (n = 145) recruited in each of the 2 stages. Of the recruited patients, 12% (34/290) withdrew before completion, with an equal number of patients withdrawing in stage 1 and 2. A total of 5% (14/290) of patients withdrew before commencing the study when the first telephone contact was made at baseline (2 days before commenc-
ing chemotherapy), 3% (8/290) withdrew 1 week after their initial chemotherapy session, and 4% (12/290) withdrew 1 month after their initial chemotherapy session. Reasons for withdrawal included death, being too stressed or anxious by their prognosis to continue with the study, deciding to cancel their chemotherapy, and being too ill to continue with their chemotherapy. The mean (SD) age of participants overall was 61 (12.5) years; those in stage 1 had a mean (SD) age of 60 (12.9) years, whereas those in stage 2 were older, with a mean (SD) age of 62 (12.0) years. Of the 276 participants who commenced the study, 58% (159/276) were women and 42% (117/276) were men. There were more women than men in stage 1 (53%, 73/138) and stage 2 (62%, 86/138). The 3 most prevalent types of cancer experienced were breast (23%, 63/276), gastrointestinal (22%, 61/276), and lung (22%, 60/276). Most (84%, 232/276) participants were prescribed combined chemotherapy medication, with platinumbased chemotherapy being most common (42%, 115/276). Compared with those in stage 1, patients in stage 2 were more likely to experience 4 or more symptoms (OR, 1.82; 95% CI, 1.12Y2.96; P = .015) and be more anxious or worried at baseline (73% vs 50%; P G .001). Before commencing chemotherapy, patients were already experiencing psychological and physical symptoms. Psychological symptoms included feeling anxious or worried (65%, 178/276) and unusually tired (60%, 166/276). Physical symptoms included pain (55%, 152/276) and constipation (28%, 78/276) (Table 1). The symptoms of feeling anxious or worried, tired, and pain were significantly higher in prevalence in stage 2 to stage 1. In multivariable analysis, there were 3 symptoms for which the interaction between stage and time was significant: feeling low, vomiting, and problems with the mouth and throat. Participants in stage 2 did not experience any change in feeling low across time, but those in stage 1 were found to be more likely to feel low, when monthly rates were compared with baseline rates (OR, 2.33; 95% CI, 1.47Y3.70; P G .001). In stage 2, participants did not experience any change in vomiting across time. However, participants in stage 1 were found to have increased vomiting when week 1 was compared with baseline (OR, 2.40; 95% CI, 1.14Y5.06; P = .021) and 1 month was compared with baseline (OR, 2.37; 95% CI, 1.13Y4.97; P = .022). Problems with mouth and throat increased across time irrelevant of stage (Table 2). The severity of most symptoms did not differ significantly between the stages of the study. Exceptions were the severity of pain (P = .025) and feeling anxious or worried (P = .008) at baseline; pain (P = .030), feeling anxious or worried (P = .047), and feeling low (P = .028) at 1 week after initial chemotherapy treatment; and pain (P = .045) and feeling anxious or worried (P = .010) at 1 month after initial chemotherapy treatment. Participants who experienced these symptoms reported a greater degree of severity in stage 2. Compared with stage 1, bother was greater in stage 2 at baseline for vomiting (P = .040), pain (P = .017), feeling tired (P = .038), feeling anxious or worried (P = .001), and feeling low (P = .024). However, by 1 week, the degree of bother differed significantly only for pain (P = .008) and feeling low (P = .002). By 1 month, only feeling anxious or worried (P = .023) and feeling low (P = .006) differed significantly. Participants who
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Table 1 & Prevalence, Severity, and Bother of Symptoms for Stages 1 and 2 Combined Prevalence
Severity
Bother
Variable
Baseline
Weekly
Monthly
Baseline
Weekly
Monthly
Baseline
Weekly
Monthly
Nausea Vomiting Constipation Diarrhea Problems with mouth/throat Unusually tired Pain Feeling anxious or worried Feeling Low
56 33 78 37 52 166 152 178 85
138 38 154 66 120 197 128 83 90
120 (47) 34 (13) 118 (46) 71 (28) 123 (48) 188 (73) 123 (48) 87 (34) 102 (40)
25 (45) 20 (61) 57 (67) 9 (24) 20 (38) 107 (64) 89 (59) 105 (59) 50 (59)
58 21 88 30 45 121 76 57 52
66 22 75 40 64 138 72 53 60
21 21 35 5 29 92 70 130 61
52 14 70 17 34 62 59 48 37
59 22 58 30 37 91 58 47 56
(20) (12) (28) (13) (19) (60) (55) (65) (31)
(51) (14) (57) (43) (45) (74) (48) (31) (34)
(42) (55) (57) (45) (38) (61) (59) (69) (58)
(55) (65) (64) (56) (52) (73) (59) (61) (59)
(38) (64) (45) (14) (56) (55) (46) (73) (72)
(38) (37) (80) (26) (28) (31) (46) (58) (41)
(49) (65) (49) (42) (30) (48) (47) (54) (55)
Data are presented as n (%). Baseline data concern data collected before commencing chemotherapy. Weekly and monthly data concern data collected at 1 week and 1 month after initial chemotherapy treatment, respectively. The frequencies of those who experienced severity and bother are calculated from the prevalence of those experiencing the symptom at the correlating time (baseline, weekly, and monthly time points). Severity is recorded from those with moderate or severe severity. Bother is recorded for those with quite a bit or very much bother.
experienced these symptoms reported a greater degree of bother in stage 2. A number of participants (31%, 39/128) did not use the EBGs. The main reasons for not using the EBGs included being given too much information, deciding to find their own information on the Internet, being too stressed by potential symptoms to read about them, and misplacing the EBGs. Of the 70% (89/128) who read the guidelines, most (96%, 85 of 89) perceived that the guidelines met their needs. The main reasons given for this perception were that they were well laid out, clear, easy to read, and straightforward.
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Discussion
Baseline
which may have exacerbated this symptom. However, research in relation to coping with symptom burden has not identified a clear anxiety trajectory. Anxiety often peaks before treatment, but it can also peak at different times during an individual’s cancer journey.18 Those receiving chemotherapy for cancer often have personalized methods for coping with anxiety, which may include positive strategies such as problem solving or negative strategies such as avoidance.38 Participants in stage 2 received their chemotherapy in conjunction with major changes within the hospital’s infrastructure, both in terms of staffing and moving the cancer center to a new site. Although we have no evidence to link these factors to the increased number of symptoms experienced and the anxiety and worry that stage 2 participants experienced at baseline, the impact of the hospital environment cannot be ignored.
Symptom Trajectories 14,20,26
This study reinforces the findings of others that before commencing chemotherapy, many patients are already experiencing psychological and physical symptoms associated with their cancer. Compared with those in stage 1, stage 2 participants were more likely to experience 4 or more symptoms (P = .015) at baseline. Although others have found that cancer patients experience numerous symptoms before commencing chemotherapy,12,14,16 establishing a reason for the baseline symptom difference between the 2 cohorts was difficult as they were similar in terms of age, sex, gender, and cancer diagnosis. Another explanation for the baseline differences could be that exposure to the EBGs encouraged those in stage 2 to focus on their symptoms. Previous research has found that patients’ expectations of the symptoms they experience may have a negative impact on their quality of life during chemotherapy.36 This may help to explain why those in stage 2 experienced significantly more anxiety and worry. In addition, increased symptom burden has been found by others to be linked to anxiety,18,33,37
Despite being at a disadvantage at baseline (in terms of increased likelihood of feeling anxious or worried and number of symptoms), participants in stage 2 did better at managing feeling low and vomiting, whereas problems with mouth and throat increased across time irrelevant of stage. Depression and anxiety are consistently found to coexist.39 In multivariable analysis, no differences were found between stages in relation to anxiety and worry. However, participants in stage 2 were more likely than those in stage 1 to experience and report a greater degree of severity and bother. Depression is consistently associated with chemotherapy in patients.14,20 This study appeared to have a positive impact on the rates of feeing low, as only stage 1 participants experienced increased rates of feeling low. It is possible that participants in stage 2 derived psychological benefit from the extra time spent on the telephone (as a result of the additional questions in relation to the EBGs) with a nurse not involved in their care. Research has found that information and provision of support from
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Table 2 & Unadjusted and Adjusted Results of Symptoms Where an Interaction Between Stage and Time Was Significant
Univariate
Feeling low Age Female vs male Stage 2 vs stage 1 Time Weekly vs baseline Monthly vs baseline Monthly vs baseline Time Stage 1 weekly vs baseline Stage 2 weekly vs baseline Stage 1 monthly vs baseline Stage 2 monthly vs baseline Vomit Age Female vs Male Stage 2 vs stage 1 Time Weekly vs baseline Monthly vs baseline Monthly vs baseline Time Stage 1 weekly vs baseline Stage 2 weekly vs baseline Stage 1 monthly vs baseline Stage 2 monthly vs baseline Problems with mouth and throat Age Female vs male Stage 2 vs stage 1 Time Weekly vs baseline Monthly vs baseline Monthly vs baseline Time Stage 1 weekly vs baseline Stage 2 weekly vs baseline Stage 1 monthly vs baseline Stage 2 monthly vs baseline
Multivariate
OR (95% CI)
OR (95% CI)
P
0.98 (0.96Y0.99) 0.99 (0.68Y1.43) 0.98 (0.68Y1.42)
0.98 (0.96Y0.99)
.004 N/S .050
1.14 (0.85Y1.51) 1.49 (1.07Y2.06) 1.31 (1.00Y1.72)
.002
1.51 0.88 2.33 0.99
(0.99Y2.31) (0.58Y1.31) (1.47Y3.70) (0.61Y1.59)
.06 .519 G.001 .954
0.98 (0.96Y1.00) 1.05 (0.63Y1.76) 1.06 (0.64Y1.76)
N/S N/S .740
1.22 (0.79Y1.88) 1.13 (0.72Y1.78) 0.93 (0.62Y1.39)
.489
2.40 0.72 2.37 0.61
(1.14Y5.06) (0.42Y1.23) (1.13Y4.97) (0.34Y1.12)
.022 .231 .022 .110
0.99 (0.98Y1.00) 1.18 (0.85Y1.63) 1.17 (0.85Y1.62)
N/S N/S .538
3.49 (2.42Y5.04) 3.95 (2.73Y5.72) 1.13 (0.86Y1.50)
G.001
4.28 2.87 3.29 4.74
(2.52Y7.25) (1.73Y4.77) (1.97Y5.50) (2.77Y8.12)
G.001 G.001 G.001 G.001
Stage is defined as stage 1 or 2. Baseline data concern data collected before commencing chemotherapy. Weekly and monthly data concern data collected at 1 week and 1 month after initial chemotherapy treatment, respectively. Abbreviations: CI, confidence interval; N/S, not significant; OR, odds ratio.
a trusted individual via a telephone assists people with cancer; a recent Cochrane review suggested that nurse-delivered interventions, which include information combined with supportive attention, may have a positive impact on mood in newly diagnosed cancer patients.40 Nausea was experienced by half the participants during their chemotherapy, and although it was apparent that the severity and bother of nausea were troublesome across time, neither were impacted by stage. Participants in stage 1 experienced increased vomiting, whereas those in stage 2 experienced no change. The finding that vomiting can be reduced with an intensive che-
motherapy education program has been described previously41,42 and suggests that focus on this toxicity is productive, especially if it is modified to meet individuals’ needs before commencing chemotherapy.41 Chemotherapy-induced nausea and vomiting are associated with deterioration in quality of life43 being feared by many chemotherapy patients. Practitioners have been found to underestimate the occurrence of nausea and vomiting, particularly delayed symptoms. Research continually points to the need for a standardized assessment tool and management protocol to meet the needs of both chemotherapy staff 37,42 and patients.37,41
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Problems with the mouth and throat increased across time irrelevant of stage, with no significant difference found in severity or bother between stages. Chemotherapy is associated with oral and throat complications, especially oral mucositis, which presents a unique set of challenges because of its complex pathogenesis.44 Although the evidence for basic oral care is supported,44 it has been debated whether basic oral care (used by our EBGs) can interrupt the molecular factors that result in mucosal tissue damage.44 Although evidence is building in this area, there has been a call for improved evidence to guide future clinical care.44 The prevalence of reported pain was high in both stages being present in more than half (55%) the participants at baseline. This is likely to be linked to previous surgery rather than the cancer itself.14 As many treatment options are available at our tertiary cancer center, this finding was disappointing. In our study, participants in stage 2 reported greater severity of pain than did those in stage 1 at baseline (P = .025) and 1 week (P = .030) and 1 month (P = .045) after initial chemotherapy. In addition, participants in stage 2 were more likely than those in stage 1 to find their pain bothersome at baseline (P = .017) and 1 week after initial chemotherapy (P = .008). These findings suggest that encouraging individuals to focus on their symptoms may not always be beneficial. Others have found that despite the availability of EBGs for pain, barriers to integration continue to exist, with suboptimal reassessment processes and lack of documentation contributing toward poor pain management in chemotherapy patients.29,30
Evidence-Based Guidelines Previous research investigating the use of EBGs has highlighted the difficulties related to consistent use of these guidelines in clinical practice.29 Reflections on the patients’ evaluations of the EBGs suggest that a more individually focused approach could be more beneficial. A number of the patients felt overwhelmed by the amount of information given to them. Providing patients with a guiding pathway for access to information as needed may be a preferable approach, especially for the prevalence of psychological symptoms that seem to be associated with increased severity and bother. The development of online information resources for patients undergoing chemotherapy could be considered to address symptom burden and psychological distress as needed. Provision of basic information before commencement of therapies regarding preventative measures and the availability of support and information via the telephone throughout the treatment period could also be considered.
Limitations This study had a number of limitations. First, chemotherapy staff were aware that the EBGs were being implemented and patients’ symptoms were being assessed, and this could have confounded the results. Second, the study was undertaken at a single tertiary referral center and studied only cancer patients who were receiving chemotherapy for the first time. Third, we could consider only patients who spoke English. Fourth, as mentioned
above, patients in stage 2 received their chemotherapy during a time of major change within the cancer unit.
Conclusion It is evident that before commencing chemotherapy, many patients are already experiencing psychological and physical symptoms associated with their cancer. Providing patients with a pathway for access to information as needed may be a preferable approach to giving them multiple EBGs. This is especially important for those who experience psychological symptoms, which seem to be associated with increased severity and bother. Further research incorporating more hospital settings and addressing issues experienced by nonYEnglish speaking patients is needed to build on this work. ACKNOWLEDGMENTS
We would like to acknowledge Ms Dianne Grennan and Ms Cathy Pienaar for their assistance with data collection. We would also like to thank Vivienne Brown for use of the C-SAS.
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