Symptoms, unmet needs, psychological well-being and health status in survivors of prostate cancer: implications for redesigning follow-up Eila Watson, Bethany Shinkins†, Emma Frith‡, David Neal‡, Freddie Hamdy§, Fiona Walter¶, David Weller**, Clare Wilkinson††, Sara Faithfull‡‡, Jane Wolstenholme§§, Prasanna Sooriakumaran§, Christof Kastner‡, Christine Campbell**, Richard Neal††, Hugh Butcher¶¶, Mike Matthews¶¶, Rafael Perera† and Peter Rose† Department of Clinical Health Care, Oxford Brookes University , †Nuffield Department of Primary Health Care, University of Oxford, Oxford , ‡Department of Surgical Oncology, Cambridge University Hospitals Trust, Cambridge , §Nuffield Department of Surgical Sciences, University of Oxford, Oxford , ¶Department of Public Health and Primary Care, University of Cambridge, Cambridge , **Centre for Population Health Sciences, University of Edinburgh, Edinburgh , †† North Wales Centre for Primary Care Research, Bangor University, Bangor , ‡‡Division of Health and Social Care, University of Surrey, Surrey , §§Health Economics Research Centre, University of Oxford, Oxford, UK, and ¶¶Service User Representatives, Resident in UK
Objective To explore ongoing symptoms, unmet needs, psychological wellbeing, self-efficacy and overall health status in survivors of prostate cancer.
Patients and Methods An invitation to participate in a postal questionnaire survey was sent to 546 men, diagnosed with prostate cancer 9–24 months previously at two UK cancer centres. The study group comprised men who had been subject to a range of treatments: surgery, radiotherapy, hormone therapy and active surveillance. The questionnaire included measures of prostate-related quality of life (Expanded Prostate cancer Index Composite 26-item version, EPIC-26); unmet needs (Supportive Care Needs Survey 34-item version, SCNS-SF34); anxiety and depression (Hospital Anxiety and Depression Scale, HADS), self-efficacy (modified Self-efficacy Scale), health status (EuroQol 5D, EQ-5D) and satisfaction with care (questions developed for this study). A single reminder was sent to non-responders after 3 weeks. Data were analysed by age, co-morbidities, and treatment group.
for psychosocial than physical aspects of care. Urinary, bowel, and sexual functioning was reported as a moderate/big problem in the last month for 15.2% (n = 48), 5.1% (n = 16), and 36.5% (n = 105) men, respectively. The most commonly reported moderate/high unmet needs related to changes in sexual feelings/ relationships, managing fear of recurrence/uncertainty, and concerns about the worries of significant others. It was found that 17% of men (51/307) reported potentially moderate-to-severe levels of anxiety and 10.2% (32/308) reported moderate-to-severe levels of depression. The presence of problematic side-effects was associated with higher psychological morbidity, poorer selfefficacy, greater unmet needs, and poorer overall health status.
Conclusion While some men report relatively few problems after prostate cancer treatment, this study highlights important physical and psycho-social issues for a significant minority of survivors of prostate cancer. Strategies for identifying those men with ongoing problems, alongside new interventions and models of care, tailored to individual needs, are needed to improve quality of life.
Results
Keywords
In all, 316 men completed questionnaires (64.1% response rate). Overall satisfaction with follow-up care was high, but was lower
prostate cancer, follow-up care, survivors, quality of life, primary care
Introduction Prostate cancer is the commonest non-dermatological cancer in men in the Western world. In 2011 there were 41 736 new cases in the UK, and >10 000 deaths [1]. Although it represents the second commonest cause of death from cancer,
BJU Int 2016; 117: E10–E19 wileyonlinelibrary.com
improvements in early detection and treatment strategies has resulted in a global improvement in survival statistics, more marked in economically developed nations [1,2]. Treatments for localised disease include radical prostatectomy, external beam radiotherapy, and brachytherapy, often with androgendeprivation therapy (ADT). Active surveillance is offered to © 2015 The Authors BJU International © 2015 BJU International | doi:10.1111/bju.13122 Published by John Wiley & Sons Ltd. www.bjui.org
Health issues in survivors of prostate cancer
men whose disease is considered clinically insignificant for them at the time of diagnosis, with regular re-assessment of disease and patient factors to determine if and when a need for radical therapy arises; its underlying premise is to avoid or delay morbidity associated with the afore-mentioned treatments. Locally advanced disease is typically managed with radiotherapy plus ADT, with some proponents offering surgery as part of multimodal therapy [3], whereas metastatic prostate cancer is usually managed by initial ADT alone [4]. Over and above regular PSA monitoring for the detection of recurrence, it is recognised that patients with prostate cancer can have a wide range of follow-up needs including the management of both physical and psycho-social side-effects of diagnosis and treatment [5,6]. However, a recent survey conducted by Prostate Cancer UK reported that over a quarter of men felt that the provision of good quality information and support was not adequate for their needs, and almost one-third reported followup care was not sufficient in terms of addressing the side-effects of treatment [7]. Previous studies have also highlighted supportive care needs [8,9] and shortcomings with existing follow-up services [10] in this patient population. The increase in demand for follow-up care is placing a significant strain on hospital outpatient clinics. To resolve this, it has been suggested that primary care could play a larger role in cancer follow-up [11]. The National Institute for Health and Care Excellence (NICE) currently recommends a move to follow-up outside of the hospital setting for patients with prostate cancer who are stable at 24 months after diagnosis [12], although findings from a recent audit indicate that specialist multi-disciplinary teams in England currently expect 30% of patients with prostate cancer with low-risk disease who receive radical treatment to be followed up for >5 years, despite the low risk of relapse [13]. This audit report also recommends that the availability of personal support services including cancer advisory centres, sexual function and continence advice, and psychological counselling should be improved [13]. The American Cancer Society have recently published their guidelines advocating that follow-up care should be provided in the primary care setting soon after hospital treatment finishes [14]. The present survey was conducted as the first phase of a larger study developing and pilot testing a nurse-led psychoeducational intervention delivered to men in primary care (PROSPECTIV) [15]. In a sample of UK men with prostate cancer who had completed initial treatment and were living with stable disease, we assessed: (i) symptoms experienced and the extent to what men found these bothersome; (ii) unmet needs; (iii) psychological morbidity; (iv) self-efficacy; (v) satisfaction with care; and (vi) overall health status, with a view to informing new models of follow-up. We collected this information as a baseline measure of quality of life (QoL) outcomes against which to compare the findings of our future
intervention study, and to inform the development of alternative models of follow-up.
Patients and Methods Recruitment Men were recruited to the study from two cancer centres in the UK (Oxford University Hospitals NHS Trust and Cambridge University Hospitals NHS Foundation Trust). We sought to invite all men diagnosed 9–24 months previously, regardless of treatment method, whose condition was considered stable as judged by the most recent PSA test result. We selected 9 months after diagnosis as the time when most radical treatments would have been completed. We used the following criteria as an indication of stable disease: surgical patients: PSA level ≤0.2 ng/mL; radiotherapy (brachytherapy or external beam) patients: PSA level ≤2 ng/ mL; and hormone therapy patients: PSA level ≤10 ng/mL. Eligible men were identified from clinic databases and clinic patient records. In all, 546 men were sent an invitation to participate, signed by a consultant from their hospital team. The invitation included a patient information sheet, a self-completion questionnaire, and a reply paid envelope. A single reminder was sent to non-responders after 3 weeks. Questionnaire The questionnaire (Appendix S1), which was designed to assess men’s care during the follow-up period after diagnosis and initial treatment, measured: clinical details; satisfaction with follow-up care (questions developed for the study); prostate-related QoL; unmet needs; psychological well-being; self-efficacy; co-morbidities; health status; and standard sociodemographic details. Wherever possible, existing validated scales were used (see below). Prostate-Related QoL Prostate-related QoL was measured using the Expanded Prostate cancer Index Composite 26-item version (EPIC-26), which is a brief, valid and reliable subjective measure of health quality in patients with prostate cancer [16]. The measure comprises 26 items across the following five domains: urinary incontinence; urinary irritation/obstruction; bowel function; sexual and vitality functions; hormonal disturbance. As well as measuring functioning in each of the domains, the measure also assesses the extent to which functioning is perceived to be a problem by the patient. Unmet Needs The Supportive Care Needs Survey 34-item version (SCNSSF34) assesses respondents’ current level of need across the
© 2015 The Authors BJU International © 2015 BJU International
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following domains: psychological, health system and information, physical and daily activity, patient care, and support and sexuality. Need is rated on a 5-point scale ranging from ‘no need’ to ‘high need’ (1 = no need, 2 = need was satisfied, 3 = low need, 4 = moderate need, 5 = high need) [17]. This validated instrument has been previously used in cancer survivorship studies [18].
from ‘not at all satisfied (score = 1)’ to ‘totally satisfied (score = 5)’, how well their follow-up care had addressed any (i) physical problems/symptoms, (ii) emotional/psychological problems, (iii) relationship problems, and (iv) social problems. A final item asked participants to rate their overall satisfaction with general support and care, using the same Likert scale. Items were analysed individually.
Psychological Wellbeing
Statistical Analysis
Psychological wellbeing was assessed using the Hospital Anxiety and Depression Scale (HADS) [19]. The HADS is a validated and widely used, 14-item screening instrument for assessing levels of anxiety and depression in patients. Each item is scored from 0 to 3. The anxiety and depression subscores are both on scales of 0–21. Scores of 8–10 on either sub-scale indicate possible cases, and scores of ≥11 indicate probable cases. The HADS has also previously been used in studies of cancer survivors [20].
Data analysis was undertaken using SPSS software version 22.0. Descriptive statistics were produced, using medians and interquartile ranges (IQRs) instead of means and standard deviations (SDs) in cases of heavily skewed data. The standardised questionnaires were analysed and missing data handled in accordance with their respective guidelines. Associations between the reporting of moderate or large problems according to the EPIC questions and other measures included in the questionnaire were explored. In addition, sub-group analyses based on age (≤65 vs >66 years), co-morbidities (0 vs 1 vs >1), and treatment group were carried out. Statistical significance tests were only carried out if clinically significant differences were seen. Independent samples t-tests were used to compare means, and the nonparametric equivalent was used to compare medians in the case of skewed data. Proportions were compared using the chi-square test. Associations could not be explored using multivariate regression analyses due to limitations in the sample size, particularly in terms of the low numbers within each treatment group.
Self-Efficacy The Self-Efficacy for Managing Chronic Disease Scale [21] was developed to measure self-efficacy in people with chronic conditions and has also been used for patients with cancer [22]. Respondents rate their confidence to perform six self-management behaviours (1 = ‘not at all confident’ to 10 = ‘totally confident’). A mean score is calculated (range 1–10) with a high score indicating high self-efficacy. Following the method of Foster et al. [22], we added five cancer-specific self-management behaviours using the same rating scale and calculated a mean score (range 1–10). This new Cancer Survivors Self Efficacy Scale of 11 items has been shown to form a strongly homogenous, uni-dimensional scale of selfefficacy (H = 0.54) with excellent reliability (a = 0.92) [22]. Health Status The EuroQol (EQ)-5D-5L was used as a measure of health status [23]. A crosswalk algorithm was used to convert the 5L EQ5D to the 3L version [24]. Each of the five dimensions in the EQ-5D (mobility, self-care, activities, pain/discomfort, and anxiety/depression) is scored from 1 (no problem) to 3 (extreme problem), generating a profile (e.g. 11232) that can be used to calculate a single index score (range 0.04–1.000). The EQ-5D also generates a self-rating of health-related QoL scored from 0 to 100 on a visual analogue scale. Satisfaction with Care As we were unable to find any suitable, previously validated measures, satisfaction with care was measured using five questions developed for this study. User representatives were involved in developing and pilot testing the questions, which asked participants to rate, on a 5-point Likert scale ranging
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© 2015 The Authors BJU International © 2015 BJU International
Results Recruitment and Sample Characteristics In all, 546 questionnaires were posted and 369 completed questionnaires were returned. Of these, 53 were excluded because the date of diagnosis given by the respondent on the questionnaire was outside our inclusion criteria, leaving a total of 316 responses from a potentially eligible population of 493 (response rate 64.1%). There was no significant difference between respondents and non-respondents by age, time since diagnosis, and recruitment centre. Sample demographics and clinical characteristics are presented in Table 1. The mean (SD, range) age of the sample was 67.8 (7.6, 46–88 years), most were married (n = 275, 89%), and the overwhelming majority were White British (n = 292, 95%). At the time of completing the survey, the mean (SD) time since initial diagnosis was 17.1 (4.50) months. Just over a third of patients had undergone surgery (n = 115, 37%) or radiotherapy (n = 117, 37%) as their primary treatment for prostate cancer, with most of those undergoing radiotherapy also receiving adjuvant hormone therapy (n = 81, 26%).
Health issues in survivors of prostate cancer
Table 1 Patient demographics and disease characteristics. Variable/characteristic Total number of patients Median (IQR) Age, years (n = 293) Time since diagnosis, months (n = 315) N (%) Marital status Single Married/cohabiting Widowed Divorced/separated Other Total Employment Status In paid work Temporarily off sick Unemployed Retired Long-term disability or ill health Full-time education, training or work experience Other Total Ethnicity White British White – other Black – other Chinese Other Total Educational status O level/GCSE A level Clerical or commercial qualification College or university degree Postgraduate qualification None of these Total Co-morbidity Heart problems High blood pressure Chronic obstructive pulmonary disease Asthma Diabetes Arthritis Osteoporosis Inflammatory bowel disease Other At least one co-morbidity No co-morbidities Previous treatment† Surgery Radiotherapy – external beam Brachytherapy – implanted radioactive seeds Hormone Active surveillance Other
Current Care and Satisfaction with Care Value 315 68 (64–81) 17 (14–25)
6 275 12 9 7 309*
(1.9) (89.0) (3.9) (2.9) (2.3)
107 1 3 189 4 0 5 308*
(34.6) (0.3) (1.0) (61.2) (1.3)
292 11 1 1 3 308*
(94.8) (3.6) (0.3) (0.3) (1.0)
50 19 32 64 40 94 299*
(16.7) (6.4) (10.7) (21.4) (13.4) (31.4)
35 118 8 22 29 44 2 3 51 205 110
(11.1) (37.5) (2.5) (7.0) (9.2) (14.0) (0.6) (1.0) (16.2) (65.1) (34.9)
115 125 17 138 86 8
(36.5) (39.7) (5.4) (43.8) (27.3) (2.5)
(1.6)
*Total excludes missing data. †Some men had received more than one type of treatment.
Other primary treatment methods included brachytherapy (n = 17, 5%), hormone therapy only (n = 36, 11%), and active surveillance (n = 43, 14%). Four patients did not provide their treatment details. Two-thirds of respondents (n = 205, 65%) had at least one co-morbidity.
The mean (SD) time between participants’ last and next outpatient appointment was 6.6 (3.6) months, with just over half either usually or always seeing the same person (n = 191, 61%). Around half (171/315, 54%) saw a consultant at their last out-patient appointment, a quarter saw a doctor other than a consultant (73/ 315, 23%), and a fifth saw a nurse (62/315, 20%). Respondents reported a mean (SD) journey length of 43 (23) min to their last out-patient appointment, and a median (IQR) wait time of 20 (10–30) min. The mean (SD) length of their last consultation was 14 (7) min. Very few reported having a regular follow-up schedule set-up with their GP (n = 6, 2%), with most only interacting with their GP to get PSA test results (n = 195, 62%). Patients reported high levels of overall satisfaction with the support and care they had received, with a median (IQR) score 5 (4–5). However, satisfaction was lower in relation to how well emotional/psychological problems [median (IQR) score 4, (3–5)], relationship [median (IQR) score 4 (3–5)] and social problems (median (IQR) score 4 (3–5)] had been addressed, compared with physical problems [median (IQR) score 5 (4–5)]. Patient-Reported Symptoms Table 2 presents symptoms experienced in the past 4 weeks as measured by the EPIC-26, divided by primary treatment received. EPIC domain summary scores are also reported. Figure 1 presents the degree to which men reported urinary, bowel, and sexual functioning and hormone-related issues to be a problem to them in the past month. One in 10 respondents (30/315, 10%) did not answer the question relating to overall sexual function, with many indicating in the open ended text box provided that they perceived the question to be irrelevant to their current situation. Of those that did answer, around three-quarters (233/ 285, 82%) reported that their overall sexual function had been poor in the last 4 weeks. Around half (107/233, 46%) of those reporting poor overall sexual function considered this to be a moderate or big problem for them over the past month. Of those, less than half (47/107, 44%) had discussed this issue at their most recent outpatient appointment, while 16% (17/107) had previously been referred to a specialist for this reason. Nearly all were married or cohabiting with a partner (105/107, 98.1%), but there was no significant correlation with age. Sexual function was a moderate/big problem mostly among those who had hormone therapy (with or without radiotherapy) as a primary treatment (99/102; P < 0.001). Urinary and bowel functioning was considered a moderate/ big problem over the last month by 15.2% (48/315) and 5.1% (16/315), respectively. The main symptoms relating to urinary function were general incontinence issues, e.g. urinary control and leaking, in addition to the need to urinate frequently. Of those who reported their urinary or bowel function was a © 2015 The Authors BJU International © 2015 BJU International
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© 2015 The Authors BJU International © 2015 BJU International (10) (5) (11) (8) (73–100) (1) (0) (12) (17) (81–100) (16) (7) (7) (3) (3) (3) (92–100) (5) (81) (73) (86) (81) (82) (4–32) (40) (20) (3) (8) (21) (14) (75–100)
31/309 14/310 33/301 23/287 94 2/276 1/275 35/283 50/293 94 48/309 21/302 19/286 9/287 8/283 9/287 100 16/311 233/289 201/275 248/289 222/274 233/285 17 115/289 60/295 9/278 22/285 63/297 41/287 90
14 3 8 14 10 95
93 70 97 94 90 16.7 54
3 4 1 2 5 100 4
0 0 8 17 94 16
23 7 25 13 86
(13) (3) (7) (13) (9) (85–100)
(83) (64) (87) (87) (81) (4–36) (47)
(3) (4) (1) (2) (5) (96–100) (3)
(7) (15) (88–100) (14)
(21) (6) (22) (12) (67–100)
Surgery n = 115
7 2 1 6 4 95
22 21 24 23 22 13.8 12
2 2 2 1 0 92 1
0 1 4 7 88 6
2 1 1 2 100
(23) (8) (4) (19) (14) (70–100)
(73) (72) (80) (77) (73) (0–43) (39)
(83–100) (3)
(6) (7) (7) (4)
(3) (15) (23) (81–94) (17)
(6) (3) (3) (7) (79–100)
RT n = 36
†
28 4 8 28 17 75
70 64 71 66 70 12.5 28
12 12 4 5 3 94 10
1 0 10 13 88 13
3 5 3 5 100
(37) (6) (11) (36) (23) (55–90)
(93) (90) (95) (96) (96) (4–17) (38)
(15) (16) (5) (7) (4) (79–100) (13)
(14) (17) (75–100) (17)
(1)
(4) (6) (4) (7) (78–100)
RT with adjuvant HT n = 81
(16) (15) (81–100) (14)
(3)
(86–100)
(6) (3) (6)
9 0 5 10 6 78
29 27 30 27 29 16.7 9
(16) (29) (18) (68–90)
(26)
(94) (100) (97) (100) (100) (8–17) (27)
2 (6) 0 1 (3) 0 0 100 (96–100) 0
1 0 5 5 88 5
2 1 2 0 100
Primary HT n = 36
(23) (19) (75–100) (17)
(5) (8) (86–100)
(2)
‡
2 0 0 5 4 95
16 17 23 17 19 57 11
(13) (12) (90–100)
(5)
(43) (49) (61) (47) (50) (13–88) (30)
1 (3) 0 0 0 1 (3) 100 (96–100) 0
0 0 8 7 88 7
1 0 2 3 93.8
AS n = 43
Objective To explore ongoing symptoms, unmet needs, psychological wellbeing, self-efficacy and overall health status in survivors of prostate cancer.
Patients and Methods An invitation to participate in a postal questionnaire survey was sent to 546 men, diagnosed with prostate cancer 9–24 months previously at two UK cancer centres. The study group comprised men who had been subject to a range of treatments: surgery, radiotherapy, hormone therapy and active surveillance. The questionnaire included measures of prostate-related quality of life (Expanded Prostate cancer Index Composite 26-item version, EPIC-26); unmet needs (Supportive Care Needs Survey 34-item version, SCNS-SF34); anxiety and depression (Hospital Anxiety and Depression Scale, HADS), self-efficacy (modified Self-efficacy Scale), health status (EuroQol 5D, EQ-5D) and satisfaction with care (questions developed for this study). A single reminder was sent to non-responders after 3 weeks. Data were analysed by age, co-morbidities, and treatment group.
for psychosocial than physical aspects of care. Urinary, bowel, and sexual functioning was reported as a moderate/big problem in the last month for 15.2% (n = 48), 5.1% (n = 16), and 36.5% (n = 105) men, respectively. The most commonly reported moderate/high unmet needs related to changes in sexual feelings/ relationships, managing fear of recurrence/uncertainty, and concerns about the worries of significant others. It was found that 17% of men (51/307) reported potentially moderate-to-severe levels of anxiety and 10.2% (32/308) reported moderate-to-severe levels of depression. The presence of problematic side-effects was associated with higher psychological morbidity, poorer selfefficacy, greater unmet needs, and poorer overall health status.
Conclusion While some men report relatively few problems after prostate cancer treatment, this study highlights important physical and psycho-social issues for a significant minority of survivors of prostate cancer. Strategies for identifying those men with ongoing problems, alongside new interventions and models of care, tailored to individual needs, are needed to improve quality of life.
Results
Keywords
In all, 316 men completed questionnaires (64.1% response rate). Overall satisfaction with follow-up care was high, but was lower
prostate cancer, follow-up care, survivors, quality of life, primary care
Introduction Prostate cancer is the commonest non-dermatological cancer in men in the Western world. In 2011 there were 41 736 new cases in the UK, and >10 000 deaths [1]. Although it represents the second commonest cause of death from cancer,
BJU Int 2016; 117: E10–E19 wileyonlinelibrary.com
improvements in early detection and treatment strategies has resulted in a global improvement in survival statistics, more marked in economically developed nations [1,2]. Treatments for localised disease include radical prostatectomy, external beam radiotherapy, and brachytherapy, often with androgendeprivation therapy (ADT). Active surveillance is offered to © 2015 The Authors BJU International © 2015 BJU International | doi:10.1111/bju.13122 Published by John Wiley & Sons Ltd. www.bjui.org
Health issues in survivors of prostate cancer
men whose disease is considered clinically insignificant for them at the time of diagnosis, with regular re-assessment of disease and patient factors to determine if and when a need for radical therapy arises; its underlying premise is to avoid or delay morbidity associated with the afore-mentioned treatments. Locally advanced disease is typically managed with radiotherapy plus ADT, with some proponents offering surgery as part of multimodal therapy [3], whereas metastatic prostate cancer is usually managed by initial ADT alone [4]. Over and above regular PSA monitoring for the detection of recurrence, it is recognised that patients with prostate cancer can have a wide range of follow-up needs including the management of both physical and psycho-social side-effects of diagnosis and treatment [5,6]. However, a recent survey conducted by Prostate Cancer UK reported that over a quarter of men felt that the provision of good quality information and support was not adequate for their needs, and almost one-third reported followup care was not sufficient in terms of addressing the side-effects of treatment [7]. Previous studies have also highlighted supportive care needs [8,9] and shortcomings with existing follow-up services [10] in this patient population. The increase in demand for follow-up care is placing a significant strain on hospital outpatient clinics. To resolve this, it has been suggested that primary care could play a larger role in cancer follow-up [11]. The National Institute for Health and Care Excellence (NICE) currently recommends a move to follow-up outside of the hospital setting for patients with prostate cancer who are stable at 24 months after diagnosis [12], although findings from a recent audit indicate that specialist multi-disciplinary teams in England currently expect 30% of patients with prostate cancer with low-risk disease who receive radical treatment to be followed up for >5 years, despite the low risk of relapse [13]. This audit report also recommends that the availability of personal support services including cancer advisory centres, sexual function and continence advice, and psychological counselling should be improved [13]. The American Cancer Society have recently published their guidelines advocating that follow-up care should be provided in the primary care setting soon after hospital treatment finishes [14]. The present survey was conducted as the first phase of a larger study developing and pilot testing a nurse-led psychoeducational intervention delivered to men in primary care (PROSPECTIV) [15]. In a sample of UK men with prostate cancer who had completed initial treatment and were living with stable disease, we assessed: (i) symptoms experienced and the extent to what men found these bothersome; (ii) unmet needs; (iii) psychological morbidity; (iv) self-efficacy; (v) satisfaction with care; and (vi) overall health status, with a view to informing new models of follow-up. We collected this information as a baseline measure of quality of life (QoL) outcomes against which to compare the findings of our future
intervention study, and to inform the development of alternative models of follow-up.
Patients and Methods Recruitment Men were recruited to the study from two cancer centres in the UK (Oxford University Hospitals NHS Trust and Cambridge University Hospitals NHS Foundation Trust). We sought to invite all men diagnosed 9–24 months previously, regardless of treatment method, whose condition was considered stable as judged by the most recent PSA test result. We selected 9 months after diagnosis as the time when most radical treatments would have been completed. We used the following criteria as an indication of stable disease: surgical patients: PSA level ≤0.2 ng/mL; radiotherapy (brachytherapy or external beam) patients: PSA level ≤2 ng/ mL; and hormone therapy patients: PSA level ≤10 ng/mL. Eligible men were identified from clinic databases and clinic patient records. In all, 546 men were sent an invitation to participate, signed by a consultant from their hospital team. The invitation included a patient information sheet, a self-completion questionnaire, and a reply paid envelope. A single reminder was sent to non-responders after 3 weeks. Questionnaire The questionnaire (Appendix S1), which was designed to assess men’s care during the follow-up period after diagnosis and initial treatment, measured: clinical details; satisfaction with follow-up care (questions developed for the study); prostate-related QoL; unmet needs; psychological well-being; self-efficacy; co-morbidities; health status; and standard sociodemographic details. Wherever possible, existing validated scales were used (see below). Prostate-Related QoL Prostate-related QoL was measured using the Expanded Prostate cancer Index Composite 26-item version (EPIC-26), which is a brief, valid and reliable subjective measure of health quality in patients with prostate cancer [16]. The measure comprises 26 items across the following five domains: urinary incontinence; urinary irritation/obstruction; bowel function; sexual and vitality functions; hormonal disturbance. As well as measuring functioning in each of the domains, the measure also assesses the extent to which functioning is perceived to be a problem by the patient. Unmet Needs The Supportive Care Needs Survey 34-item version (SCNSSF34) assesses respondents’ current level of need across the
© 2015 The Authors BJU International © 2015 BJU International
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following domains: psychological, health system and information, physical and daily activity, patient care, and support and sexuality. Need is rated on a 5-point scale ranging from ‘no need’ to ‘high need’ (1 = no need, 2 = need was satisfied, 3 = low need, 4 = moderate need, 5 = high need) [17]. This validated instrument has been previously used in cancer survivorship studies [18].
from ‘not at all satisfied (score = 1)’ to ‘totally satisfied (score = 5)’, how well their follow-up care had addressed any (i) physical problems/symptoms, (ii) emotional/psychological problems, (iii) relationship problems, and (iv) social problems. A final item asked participants to rate their overall satisfaction with general support and care, using the same Likert scale. Items were analysed individually.
Psychological Wellbeing
Statistical Analysis
Psychological wellbeing was assessed using the Hospital Anxiety and Depression Scale (HADS) [19]. The HADS is a validated and widely used, 14-item screening instrument for assessing levels of anxiety and depression in patients. Each item is scored from 0 to 3. The anxiety and depression subscores are both on scales of 0–21. Scores of 8–10 on either sub-scale indicate possible cases, and scores of ≥11 indicate probable cases. The HADS has also previously been used in studies of cancer survivors [20].
Data analysis was undertaken using SPSS software version 22.0. Descriptive statistics were produced, using medians and interquartile ranges (IQRs) instead of means and standard deviations (SDs) in cases of heavily skewed data. The standardised questionnaires were analysed and missing data handled in accordance with their respective guidelines. Associations between the reporting of moderate or large problems according to the EPIC questions and other measures included in the questionnaire were explored. In addition, sub-group analyses based on age (≤65 vs >66 years), co-morbidities (0 vs 1 vs >1), and treatment group were carried out. Statistical significance tests were only carried out if clinically significant differences were seen. Independent samples t-tests were used to compare means, and the nonparametric equivalent was used to compare medians in the case of skewed data. Proportions were compared using the chi-square test. Associations could not be explored using multivariate regression analyses due to limitations in the sample size, particularly in terms of the low numbers within each treatment group.
Self-Efficacy The Self-Efficacy for Managing Chronic Disease Scale [21] was developed to measure self-efficacy in people with chronic conditions and has also been used for patients with cancer [22]. Respondents rate their confidence to perform six self-management behaviours (1 = ‘not at all confident’ to 10 = ‘totally confident’). A mean score is calculated (range 1–10) with a high score indicating high self-efficacy. Following the method of Foster et al. [22], we added five cancer-specific self-management behaviours using the same rating scale and calculated a mean score (range 1–10). This new Cancer Survivors Self Efficacy Scale of 11 items has been shown to form a strongly homogenous, uni-dimensional scale of selfefficacy (H = 0.54) with excellent reliability (a = 0.92) [22]. Health Status The EuroQol (EQ)-5D-5L was used as a measure of health status [23]. A crosswalk algorithm was used to convert the 5L EQ5D to the 3L version [24]. Each of the five dimensions in the EQ-5D (mobility, self-care, activities, pain/discomfort, and anxiety/depression) is scored from 1 (no problem) to 3 (extreme problem), generating a profile (e.g. 11232) that can be used to calculate a single index score (range 0.04–1.000). The EQ-5D also generates a self-rating of health-related QoL scored from 0 to 100 on a visual analogue scale. Satisfaction with Care As we were unable to find any suitable, previously validated measures, satisfaction with care was measured using five questions developed for this study. User representatives were involved in developing and pilot testing the questions, which asked participants to rate, on a 5-point Likert scale ranging
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© 2015 The Authors BJU International © 2015 BJU International
Results Recruitment and Sample Characteristics In all, 546 questionnaires were posted and 369 completed questionnaires were returned. Of these, 53 were excluded because the date of diagnosis given by the respondent on the questionnaire was outside our inclusion criteria, leaving a total of 316 responses from a potentially eligible population of 493 (response rate 64.1%). There was no significant difference between respondents and non-respondents by age, time since diagnosis, and recruitment centre. Sample demographics and clinical characteristics are presented in Table 1. The mean (SD, range) age of the sample was 67.8 (7.6, 46–88 years), most were married (n = 275, 89%), and the overwhelming majority were White British (n = 292, 95%). At the time of completing the survey, the mean (SD) time since initial diagnosis was 17.1 (4.50) months. Just over a third of patients had undergone surgery (n = 115, 37%) or radiotherapy (n = 117, 37%) as their primary treatment for prostate cancer, with most of those undergoing radiotherapy also receiving adjuvant hormone therapy (n = 81, 26%).
Health issues in survivors of prostate cancer
Table 1 Patient demographics and disease characteristics. Variable/characteristic Total number of patients Median (IQR) Age, years (n = 293) Time since diagnosis, months (n = 315) N (%) Marital status Single Married/cohabiting Widowed Divorced/separated Other Total Employment Status In paid work Temporarily off sick Unemployed Retired Long-term disability or ill health Full-time education, training or work experience Other Total Ethnicity White British White – other Black – other Chinese Other Total Educational status O level/GCSE A level Clerical or commercial qualification College or university degree Postgraduate qualification None of these Total Co-morbidity Heart problems High blood pressure Chronic obstructive pulmonary disease Asthma Diabetes Arthritis Osteoporosis Inflammatory bowel disease Other At least one co-morbidity No co-morbidities Previous treatment† Surgery Radiotherapy – external beam Brachytherapy – implanted radioactive seeds Hormone Active surveillance Other
Current Care and Satisfaction with Care Value 315 68 (64–81) 17 (14–25)
6 275 12 9 7 309*
(1.9) (89.0) (3.9) (2.9) (2.3)
107 1 3 189 4 0 5 308*
(34.6) (0.3) (1.0) (61.2) (1.3)
292 11 1 1 3 308*
(94.8) (3.6) (0.3) (0.3) (1.0)
50 19 32 64 40 94 299*
(16.7) (6.4) (10.7) (21.4) (13.4) (31.4)
35 118 8 22 29 44 2 3 51 205 110
(11.1) (37.5) (2.5) (7.0) (9.2) (14.0) (0.6) (1.0) (16.2) (65.1) (34.9)
115 125 17 138 86 8
(36.5) (39.7) (5.4) (43.8) (27.3) (2.5)
(1.6)
*Total excludes missing data. †Some men had received more than one type of treatment.
Other primary treatment methods included brachytherapy (n = 17, 5%), hormone therapy only (n = 36, 11%), and active surveillance (n = 43, 14%). Four patients did not provide their treatment details. Two-thirds of respondents (n = 205, 65%) had at least one co-morbidity.
The mean (SD) time between participants’ last and next outpatient appointment was 6.6 (3.6) months, with just over half either usually or always seeing the same person (n = 191, 61%). Around half (171/315, 54%) saw a consultant at their last out-patient appointment, a quarter saw a doctor other than a consultant (73/ 315, 23%), and a fifth saw a nurse (62/315, 20%). Respondents reported a mean (SD) journey length of 43 (23) min to their last out-patient appointment, and a median (IQR) wait time of 20 (10–30) min. The mean (SD) length of their last consultation was 14 (7) min. Very few reported having a regular follow-up schedule set-up with their GP (n = 6, 2%), with most only interacting with their GP to get PSA test results (n = 195, 62%). Patients reported high levels of overall satisfaction with the support and care they had received, with a median (IQR) score 5 (4–5). However, satisfaction was lower in relation to how well emotional/psychological problems [median (IQR) score 4, (3–5)], relationship [median (IQR) score 4 (3–5)] and social problems (median (IQR) score 4 (3–5)] had been addressed, compared with physical problems [median (IQR) score 5 (4–5)]. Patient-Reported Symptoms Table 2 presents symptoms experienced in the past 4 weeks as measured by the EPIC-26, divided by primary treatment received. EPIC domain summary scores are also reported. Figure 1 presents the degree to which men reported urinary, bowel, and sexual functioning and hormone-related issues to be a problem to them in the past month. One in 10 respondents (30/315, 10%) did not answer the question relating to overall sexual function, with many indicating in the open ended text box provided that they perceived the question to be irrelevant to their current situation. Of those that did answer, around three-quarters (233/ 285, 82%) reported that their overall sexual function had been poor in the last 4 weeks. Around half (107/233, 46%) of those reporting poor overall sexual function considered this to be a moderate or big problem for them over the past month. Of those, less than half (47/107, 44%) had discussed this issue at their most recent outpatient appointment, while 16% (17/107) had previously been referred to a specialist for this reason. Nearly all were married or cohabiting with a partner (105/107, 98.1%), but there was no significant correlation with age. Sexual function was a moderate/big problem mostly among those who had hormone therapy (with or without radiotherapy) as a primary treatment (99/102; P < 0.001). Urinary and bowel functioning was considered a moderate/ big problem over the last month by 15.2% (48/315) and 5.1% (16/315), respectively. The main symptoms relating to urinary function were general incontinence issues, e.g. urinary control and leaking, in addition to the need to urinate frequently. Of those who reported their urinary or bowel function was a © 2015 The Authors BJU International © 2015 BJU International
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© 2015 The Authors BJU International © 2015 BJU International (10) (5) (11) (8) (73–100) (1) (0) (12) (17) (81–100) (16) (7) (7) (3) (3) (3) (92–100) (5) (81) (73) (86) (81) (82) (4–32) (40) (20) (3) (8) (21) (14) (75–100)
31/309 14/310 33/301 23/287 94 2/276 1/275 35/283 50/293 94 48/309 21/302 19/286 9/287 8/283 9/287 100 16/311 233/289 201/275 248/289 222/274 233/285 17 115/289 60/295 9/278 22/285 63/297 41/287 90
14 3 8 14 10 95
93 70 97 94 90 16.7 54
3 4 1 2 5 100 4
0 0 8 17 94 16
23 7 25 13 86
(13) (3) (7) (13) (9) (85–100)
(83) (64) (87) (87) (81) (4–36) (47)
(3) (4) (1) (2) (5) (96–100) (3)
(7) (15) (88–100) (14)
(21) (6) (22) (12) (67–100)
Surgery n = 115
7 2 1 6 4 95
22 21 24 23 22 13.8 12
2 2 2 1 0 92 1
0 1 4 7 88 6
2 1 1 2 100
(23) (8) (4) (19) (14) (70–100)
(73) (72) (80) (77) (73) (0–43) (39)
(83–100) (3)
(6) (7) (7) (4)
(3) (15) (23) (81–94) (17)
(6) (3) (3) (7) (79–100)
RT n = 36
†
28 4 8 28 17 75
70 64 71 66 70 12.5 28
12 12 4 5 3 94 10
1 0 10 13 88 13
3 5 3 5 100
(37) (6) (11) (36) (23) (55–90)
(93) (90) (95) (96) (96) (4–17) (38)
(15) (16) (5) (7) (4) (79–100) (13)
(14) (17) (75–100) (17)
(1)
(4) (6) (4) (7) (78–100)
RT with adjuvant HT n = 81
(16) (15) (81–100) (14)
(3)
(86–100)
(6) (3) (6)
9 0 5 10 6 78
29 27 30 27 29 16.7 9
(16) (29) (18) (68–90)
(26)
(94) (100) (97) (100) (100) (8–17) (27)
2 (6) 0 1 (3) 0 0 100 (96–100) 0
1 0 5 5 88 5
2 1 2 0 100
Primary HT n = 36
(23) (19) (75–100) (17)
(5) (8) (86–100)
(2)
‡
2 0 0 5 4 95
16 17 23 17 19 57 11
(13) (12) (90–100)
(5)
(43) (49) (61) (47) (50) (13–88) (30)
1 (3) 0 0 0 1 (3) 100 (96–100) 0
0 0 8 7 88 7
1 0 2 3 93.8
AS n = 43
