J O U RN A L OF GE RI A TR I C O NC O LOG Y 5 ( 20 1 4 ) 1 4 8 –1 5 5
Available online at www.sciencedirect.com
ScienceDirect
Feasibility and promise of a 6-week program to encourage physical activity and reduce joint symptoms among elderly breast cancer survivors on aromatase inhibitor therapy Kirsten A. Nyropa , Hyman B. Mussb,d , Betsy Hackneya , Rebecca Clevelanda , Mary Altpeterc , Leigh F. Callahana,d,e a
Thurston Arthritis Research Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States c UNC Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States d Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States e Department of Social Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States b
AR TIC LE I N FO
ABS TR ACT
Article history:
Background: National guidelines suggest that women with hormone receptor positive breast
Received 18 June 2013
cancer be considered for adjuvant endocrine treatment with an aromatase inhibitor (AI). Joint
Received in revised form
symptoms (arthralgia) are a common AI side-effect. There is a need for effective approaches to
6 August 2013
arthralgia management that enable survivors to remain on AI therapy while optimizing as
Accepted 9 December 2013
pain-free a life as possible. This feasibility study investigates a 6-week self-directed walking
Available online 28 December 2013
program in a sample of elderly female breast cancer survivors on AIs reporting joint pain. Methods: Intervention: Walk With Ease (WWE) goal—minimum 30 min of walking 5 days a week
Keywords:
(150 min per week). Eligibility: age >65; Stage I–III breast cancer; ≥3 months of AI therapy;
Physical activity
self-reported joint pain/stiffness. Measures: (1) walking—number of days/week and number of
Arthralgia
minutes/walk, (2) visual analog scales (VAS) for joint pain, fatigue and stiffness, and (3) arthritis
Aromatase inhibitor
self-efficacy (ASE) to manage joint pain and fatigue. Statistics: t-tests, correlation coefficients and effect sizes. Results: Sample target of 20 was achieved—mean age 71 (65–87), 85% Caucasian, mean BMI 29. Proportion walking 150 min/week increased from 21% at baseline to 50% at 6 weeks (p < 0.001). Mean joint pain at baseline (39.7 + 26.9) decreased 10% (p = 0.63), fatigue (37.4 + 33.3) decreased 19% (p = 0.31), joint stiffness (46.1 + 27.2) decreased 32% (p = 0.07). Conclusions: A self-directed walking program among elderly breast cancer survivors on AI therapy significantly increased total time of walking per week over a 6 week period. Joint pain, stiffness, and fatigue also decreased, although not significantly. Testing within a larger sample is warranted. © 2013 Elsevier Ltd. All rights reserved.
1.
Introduction
Breast cancer is the most common cancer among women in the U.S., with estimated 232,340 new diagnoses in 2013 and a lifetime risk among women born today of 1 in 8.1 Most new diagnoses are made in postmenopausal women, generally at 1879-4068/$ – see front matter © 2013 Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.jgo.2013.12.002
an early and curable stage, with hormone receptor positive (HR+) tumors, and where there is a significant survival benefit from adjuvant endocrine therapy.2–5 For such patients, the American Society of Clinical Oncology Clinical Practice Guideline: Update on Adjuvant Endocrine Therapy for Women with Hormone Receptor-Positive Breast Cancer and the International Society of
J O U RN A L OF GE RI A T RI C O NC O L O G Y 5 ( 2 01 4 ) 1 4 8 – 15 5
Geriatric Oncology recommend that adjuvant endocrine therapy include a third generation aromatase inhibitor (AI) – anastrozole, exemestane, or letrozole – as part of treatment.6,7 Non-inflammatory joint pain, stiffness or achiness – known as AI-associated arthralgia (AIA) – is a common and troublesome side-effect.8–11 In clinical trials, estimates of AIA range from 5% to 36%12–15; however, reporting of musculoskeletal events was inconsistent in these trials and did not include patient-reported symptom questionnaires inquiring specifically about musculoskeletal symptoms.9,16 In clinical practice, by contrast, estimates of adverse joint symptoms are estimated as high as 33% to 74% among patients on AI therapy.17–24 Of those who report AIA, almost 70% rate their symptoms as moderate to severe.18,21 Sites most often affected include knees, feet, pelvic and hip bones, back, hands (fingers, wrists), and arms.16,23,25 Symptoms can appear anywhere from 6 weeks to 12 months of starting AI therapy, increase over time, cease upon discontinuation of AI therapy, and range from minor to moderate or severe.18,26,27 For survivors whose symptoms are moderate to severe, there are growing concerns that AIA can undermine full adherence with doctor-recommended AI dosage17,18,23,28,29 and thereby compromise treatment efficacy.3,28,30 Complete discontinuation due to side-effects ranges from 20% to 32%.18,23,31,32 Both self-medication at lower-than-recommended doses and complete discontinuation of AI due to side effects are important survivorship concerns for oncologists treating patients with breast cancer.28,33 Switching among AIs is a common AIA management option,34,35 and pharmaceutical treatment options include analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), pain modifiers, and sleep aids.3,8,10,36,37 However, to date, there have been no formal assessments of these symptom management options in clinical trials.3,9 More importantly, for too many survivors on AI therapy, pharmacological remedies provide little or no relief18 and have their own adverse side effects.38 There is a need for effective, easy-to-use, and sustainable adjunctive approaches to AIA management,30 to minimize or ameliorate symptoms so that survivors remain on AI therapy to maximize breast cancer specific survival. We conducted a pilot study to investigate whether a scalable (easy to implement) physical activity intervention – a selfdirected walking program – is feasible and potentially effective in providing relief for survivors on AI therapy who report joint pain or other joint symptoms. The general benefits of physical activity for overall survival, quality of life and cardiovascular health are already well-established through randomized controlled trials (RCTs) and observational studies conducted over the past several decades39–46; in fact, guidelines encourage persons diagnosed with cancer to participate in physical activity.47–49 The physical activity intervention evaluated in this pilot study – the Arthritis Foundation's self-directed walk with ease (WWE) program – is evidence-based for reducing self-reported arthritis or joint pain among adults. The primary outcomes of interest are the feasibility of (a) recruiting and retaining our target population for the intervention study and2 increasing walking among study participants during the 6-week WWE program. Secondary outcomes of interest were preliminary evidence of positive program impacts (promise) on patient-reported outcome measures related to joint pain, stiffness and fatigue and self-efficacy to manage joint symptoms.
2.
Experimental/Materials and Methods
2.1.
Setting and Participants
149
Target enrollment was 20 breast cancer survivors. Participants were recruited on a consecutive basis between June and October 2012 through breast cancer clinics at the North Carolina Cancer Hospital (NCCH). The study team identified potential participants – female breast cancer survivors age 65 or older and on AI therapy for three months or more – through a review of medical records of patients scheduled for an NCCH clinic visit. For each potential participant identified through this process, the treating clinician (physician or nurse practitioner) met with the patient, determined whether the patient was still on AI therapy, did not have any mitigating medical conditions (e.g., dangerous heart condition, dementia, nonambulatory), and able to engage in moderate-intensity physical activity, and then gave or withheld consent to participate in the study. Inclusion criteria were: female, age 65 or older, stage I, II or III breast cancer (if more than one breast cancer diagnosis, then the most recent diagnosis), currently on AI therapy and will be on AI therapy for the duration of the study, selfdiagnosed arthritis or joint pain or stiffness, English speaking, ability to walk and engage in moderate-intensity physical activity, and willing and able to comply with all study requirements (questionnaires and 6-week walking program). Exclusion criteria were: one or more significant medical conditions that would limit the walking intervention (such as severe cardiac disease); breast cancer surgery scheduled within the study period; or undergoing chemotherapy during the study period. During the eligibility screening process we also inquired about engagement in physical activity on a daily basis. Patients who reported already walking 5 days/week for at least 30 min/day or otherwise being very active – such as, daily tennis or jogging or similar intensity physical activities – were excluded from the study. Written informed consent was secured from eligible patients before study procedures were implemented. The study protocol was approved by the University of North Carolina at Chapel Hill (UNC) Institutional Review Board and the UNC Lineberger Comprehensive Cancer Center Protocol Review Committee.
2.2.
Design and Procedures
The study design was a single-arm intervention trial for a preliminary pre–post assessment of the impact (Cohen's effect size)50 on feasibility and outcome measures, with data collected at baseline and 6-weeks follow-up (end of intervention). Participants received a copy of the walk with ease workbook,51 a 2-page insert by the study team titled “Walk With Ease for Women with Breast Cancer on Aromatase Inhibitor Therapy”, and a daily walking diary. Upon completion of all study requirements, participants received a summary of study findings and a $25 gift card.
2.3.
Physical Activity Intervention—Walk With Ease (WWE)
We chose a low-impact walking program as our intervention because walking is a preferred physical activity of older adults
150
J O U RN A L OF GE RI A TR I C O NC O LOG Y 5 ( 20 1 4 ) 1 4 8 –1 5 5
and has been shown to improve functional status in adults with arthritis without exacerbating pain.52–54 We specifically chose the WWE program because it has been proven effective in a self-directed format (as well as group) among communitydwelling adults with self-reported arthritis or joint pain/ stiffness to improve joint pain and symptoms as well as other outcome measures after the 6-week intervention.55 Improvements in outcomes were generally maintained at 1 year.55 While arthritis and AIA are not synonymous, our underlying assumption is that AIA symptoms could be mitigated by walking in a manner similar to arthritis joint pain and stiffness symptoms. The goal of WWE is to initiate or resume and sustain an ongoing lifestyle of physical activity by walking at least 5 days a week for at least 30 accumulated minutes per day, which is the 150 min of moderate physical activity per week recommended for adults of all ages.56 Essential elements of the WWE program are reflected in chapters of the WWE workbook and focus on arthritis symptom management through exercise and motivation/behavioral change strategies. The self-directed WWE format is easy to implement under real world conditions in clinic and community settings—there are no special facilities, equipment or personnel, and it is easy to explain and do under a wide variety of individual (personal) conditions and circumstances, and easily accessed (Arthritis Foundation). After the informed consenting process, it took the Study Team an average of no more than 5 min to explain to study participants the importance of walking, how to use the WWE workbook, and the value of maintaining a walking diary, including time for questions and answers. This time frame and level of effort on the part of the study team was intentional, in order to simulate real world time-restricted implementation conditions.
2.4.
In cancer research, VAS are commonly used measures for assessing pain intensity.60,61 The Arthritis Self-Efficacy Scale (ASE) 62,63 was used to measure the WWE program's impact on perceived ability to manage joint symptoms. With each item beginning with “How certain are you that you can ….”, ASE-Pain pertains to: decreasing arthritis or joint pain, continuing daily activities, pain interference with sleep, making a small to moderate reduction in pain using methods other than extra medication, and making a large reduction in pain using methods other than extra medication. In turn, ASE-Symptom pertains to: controlling fatigue, making yourself feel better when you are feeling blue, regulating your activity so as not to aggravate pain, dealing with frustrations of pain, managing pain during daily activities, and managing symptoms so that you can do things that you enjoy. Finally, information was collected to characterize the sample: age; race; education; body mass index (BMI); and breast cancer treatment (surgery, chemotherapy, radiation therapy, AI drug).
2.5.
Statistical Analysis
Descriptive statistics were used to calculate baseline mean values. T-tests were used to calculate differences in means between baseline and 6-week follow-up. Cohen's d effect size50,64 and correlation coefficients were used to assess the association between outcome measures and walking measures. Cohen's “rules of thumb” was used for the interpretation of Cohen's d effect sizes: small = 0.20, medium = 0.50, and large = 0.80. Similarly, our interpretation of the correlation coefficient (r) was: small = 0.10, medium = 0.25, and large = 0.43. All analyses were conducted using STATA Version 9.0.65
Measures
3. The primary outcomes of interest in this pilot study were the feasibility of (a) recruiting our target population of 20 women in a clinic setting within a limited time frame (5 months) and retaining at least 80% at 6 weeks, and2 (b) increasing walking among study participants for the duration of the 6-week program. Secondary outcomes of interest pertain to the promise of WWE (preliminary estimate of program impact) in our target population on: (a) joint symptoms (pain, stiffness and fatigue) and (b) self-efficacy in managing joint symptoms. With regard to walking behavior, we asked: “How many times a week do you go for a walk for at least 10 min, for any reason, in and around your neighborhood or elsewhere?” and “How much time (minutes) do you usually spend when you go for a walk in and around your neighborhood or elsewhere?” A composite variable was created by multiplying the number of times walked per week by the number of minutes per walk. WWE program impacts on joint symptoms were measured using 0–100 mm visual analog scales (VAS)—one each for pain, fatigue and stiffness.57–59 Pain scale: How much pain have you had because of your arthritis/joint condition over the past week— no pain to pain as bad as it could be. Fatigue scale: How much of a problem has unusual fatigue or tiredness been for you over the past week—fatigue is no problem to fatigue is a major problem. Stiffness scale: How much of a problem has stiffness been for you over the past week—no stiffness to stiffness as bad as it could be.
Results
A review of medical records for scheduled patients identified 61 potential participants—female patients with breast cancer, age 65 or older on AI therapy for 3 months or more. Treating clinicians determined that: (a) 7 patients (11%) had medical conditions that were too complex for a physical activity program, (b) 10 patients (16%) were not AI compliant (stopped or never started), and (c) 13 patients (21%) were not experiencing joint pain. Of the remaining 31 patients approached by the study team, 2 patients (6%) declined to participate and 5 (16%) were determined too physically active. Of the remaining 24 patients, 4 consented but then never started the study. Of the remaining 20 patients, 19 completed all study requirements (95%); see Fig. 1. Study participants (Table 1) were primarily Caucasian (85%) and well-educated (65% with more than a high school education), with mean age of 71 years and a mean BMI of 29. Ninety-three percent had a mastectomy; 57% had a prior lumpectomy, as well. A majority of participants were taking anastrozole (63%), followed by letrozole (53%) and exemestane (28%).
3.1.
Engagement in Walking
At baseline, engagement in walking averaged 3.5 (+ 2.9) times per week and 18.4 (+ 17.1) minutes per walk, with total minutes of walking per week averaging 94.6 (+ 113.7). At
151
J O U RN A L OF GE RI A T RI C O NC O L O G Y 5 ( 2 01 4 ) 1 4 8 – 15 5
increased by 8.3 (effect size = 0.48, p < 0.05), and total minutes per week increased by 62.6 (effect size = 0.53, p < 0.001) (see Fig. 2). At 6 weeks, 69% met the WWE goal of walking 5 days/ week, 62% the goal of 30 min/walk, and 50% the goal of 150 min/week. Overall, the proportion achieving the goal of 150 min of walking per week increased from 21% to 50%. On
61 potential patients identified in the electronic medical record– age 65+ on AIs
35 not eligible 13 no joint pain 10 not AI compliant 7 too medically complex 60
Number of Minutes per Walk
40
5 already walking the desired amount or physically very active
20
26 remaining eligible
0
2 declined to participate 4 consented but then did not start the program
Baseline
6 Weeks
20 started the program
10
19 completed the program
15
Number of Walks (Times) per Week 1 did not complete the program
baseline, 42% already met the WWE goal of walking 5 days/ week, 26% the goal of 30 min/walk, but only 21% the goal of 150 min/week. At 6 weeks, all three walking measures showed significant improvements: number of times increased by 1.9 (effect size = 0.68, p < 0.001), number of minutes
0
5
Fig. 1 – Consort diagram.
Baseline
6 Weeks
28% 53% 63% 29 (19–41)
400
62% 61% 57% 93%
200
71 (65–87) 35% 85%
0
Demographics Age (years), mean (range) Education,
Available online at www.sciencedirect.com
ScienceDirect
Feasibility and promise of a 6-week program to encourage physical activity and reduce joint symptoms among elderly breast cancer survivors on aromatase inhibitor therapy Kirsten A. Nyropa , Hyman B. Mussb,d , Betsy Hackneya , Rebecca Clevelanda , Mary Altpeterc , Leigh F. Callahana,d,e a
Thurston Arthritis Research Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States c UNC Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States d Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States e Department of Social Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States b
AR TIC LE I N FO
ABS TR ACT
Article history:
Background: National guidelines suggest that women with hormone receptor positive breast
Received 18 June 2013
cancer be considered for adjuvant endocrine treatment with an aromatase inhibitor (AI). Joint
Received in revised form
symptoms (arthralgia) are a common AI side-effect. There is a need for effective approaches to
6 August 2013
arthralgia management that enable survivors to remain on AI therapy while optimizing as
Accepted 9 December 2013
pain-free a life as possible. This feasibility study investigates a 6-week self-directed walking
Available online 28 December 2013
program in a sample of elderly female breast cancer survivors on AIs reporting joint pain. Methods: Intervention: Walk With Ease (WWE) goal—minimum 30 min of walking 5 days a week
Keywords:
(150 min per week). Eligibility: age >65; Stage I–III breast cancer; ≥3 months of AI therapy;
Physical activity
self-reported joint pain/stiffness. Measures: (1) walking—number of days/week and number of
Arthralgia
minutes/walk, (2) visual analog scales (VAS) for joint pain, fatigue and stiffness, and (3) arthritis
Aromatase inhibitor
self-efficacy (ASE) to manage joint pain and fatigue. Statistics: t-tests, correlation coefficients and effect sizes. Results: Sample target of 20 was achieved—mean age 71 (65–87), 85% Caucasian, mean BMI 29. Proportion walking 150 min/week increased from 21% at baseline to 50% at 6 weeks (p < 0.001). Mean joint pain at baseline (39.7 + 26.9) decreased 10% (p = 0.63), fatigue (37.4 + 33.3) decreased 19% (p = 0.31), joint stiffness (46.1 + 27.2) decreased 32% (p = 0.07). Conclusions: A self-directed walking program among elderly breast cancer survivors on AI therapy significantly increased total time of walking per week over a 6 week period. Joint pain, stiffness, and fatigue also decreased, although not significantly. Testing within a larger sample is warranted. © 2013 Elsevier Ltd. All rights reserved.
1.
Introduction
Breast cancer is the most common cancer among women in the U.S., with estimated 232,340 new diagnoses in 2013 and a lifetime risk among women born today of 1 in 8.1 Most new diagnoses are made in postmenopausal women, generally at 1879-4068/$ – see front matter © 2013 Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.jgo.2013.12.002
an early and curable stage, with hormone receptor positive (HR+) tumors, and where there is a significant survival benefit from adjuvant endocrine therapy.2–5 For such patients, the American Society of Clinical Oncology Clinical Practice Guideline: Update on Adjuvant Endocrine Therapy for Women with Hormone Receptor-Positive Breast Cancer and the International Society of
J O U RN A L OF GE RI A T RI C O NC O L O G Y 5 ( 2 01 4 ) 1 4 8 – 15 5
Geriatric Oncology recommend that adjuvant endocrine therapy include a third generation aromatase inhibitor (AI) – anastrozole, exemestane, or letrozole – as part of treatment.6,7 Non-inflammatory joint pain, stiffness or achiness – known as AI-associated arthralgia (AIA) – is a common and troublesome side-effect.8–11 In clinical trials, estimates of AIA range from 5% to 36%12–15; however, reporting of musculoskeletal events was inconsistent in these trials and did not include patient-reported symptom questionnaires inquiring specifically about musculoskeletal symptoms.9,16 In clinical practice, by contrast, estimates of adverse joint symptoms are estimated as high as 33% to 74% among patients on AI therapy.17–24 Of those who report AIA, almost 70% rate their symptoms as moderate to severe.18,21 Sites most often affected include knees, feet, pelvic and hip bones, back, hands (fingers, wrists), and arms.16,23,25 Symptoms can appear anywhere from 6 weeks to 12 months of starting AI therapy, increase over time, cease upon discontinuation of AI therapy, and range from minor to moderate or severe.18,26,27 For survivors whose symptoms are moderate to severe, there are growing concerns that AIA can undermine full adherence with doctor-recommended AI dosage17,18,23,28,29 and thereby compromise treatment efficacy.3,28,30 Complete discontinuation due to side-effects ranges from 20% to 32%.18,23,31,32 Both self-medication at lower-than-recommended doses and complete discontinuation of AI due to side effects are important survivorship concerns for oncologists treating patients with breast cancer.28,33 Switching among AIs is a common AIA management option,34,35 and pharmaceutical treatment options include analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), pain modifiers, and sleep aids.3,8,10,36,37 However, to date, there have been no formal assessments of these symptom management options in clinical trials.3,9 More importantly, for too many survivors on AI therapy, pharmacological remedies provide little or no relief18 and have their own adverse side effects.38 There is a need for effective, easy-to-use, and sustainable adjunctive approaches to AIA management,30 to minimize or ameliorate symptoms so that survivors remain on AI therapy to maximize breast cancer specific survival. We conducted a pilot study to investigate whether a scalable (easy to implement) physical activity intervention – a selfdirected walking program – is feasible and potentially effective in providing relief for survivors on AI therapy who report joint pain or other joint symptoms. The general benefits of physical activity for overall survival, quality of life and cardiovascular health are already well-established through randomized controlled trials (RCTs) and observational studies conducted over the past several decades39–46; in fact, guidelines encourage persons diagnosed with cancer to participate in physical activity.47–49 The physical activity intervention evaluated in this pilot study – the Arthritis Foundation's self-directed walk with ease (WWE) program – is evidence-based for reducing self-reported arthritis or joint pain among adults. The primary outcomes of interest are the feasibility of (a) recruiting and retaining our target population for the intervention study and2 increasing walking among study participants during the 6-week WWE program. Secondary outcomes of interest were preliminary evidence of positive program impacts (promise) on patient-reported outcome measures related to joint pain, stiffness and fatigue and self-efficacy to manage joint symptoms.
2.
Experimental/Materials and Methods
2.1.
Setting and Participants
149
Target enrollment was 20 breast cancer survivors. Participants were recruited on a consecutive basis between June and October 2012 through breast cancer clinics at the North Carolina Cancer Hospital (NCCH). The study team identified potential participants – female breast cancer survivors age 65 or older and on AI therapy for three months or more – through a review of medical records of patients scheduled for an NCCH clinic visit. For each potential participant identified through this process, the treating clinician (physician or nurse practitioner) met with the patient, determined whether the patient was still on AI therapy, did not have any mitigating medical conditions (e.g., dangerous heart condition, dementia, nonambulatory), and able to engage in moderate-intensity physical activity, and then gave or withheld consent to participate in the study. Inclusion criteria were: female, age 65 or older, stage I, II or III breast cancer (if more than one breast cancer diagnosis, then the most recent diagnosis), currently on AI therapy and will be on AI therapy for the duration of the study, selfdiagnosed arthritis or joint pain or stiffness, English speaking, ability to walk and engage in moderate-intensity physical activity, and willing and able to comply with all study requirements (questionnaires and 6-week walking program). Exclusion criteria were: one or more significant medical conditions that would limit the walking intervention (such as severe cardiac disease); breast cancer surgery scheduled within the study period; or undergoing chemotherapy during the study period. During the eligibility screening process we also inquired about engagement in physical activity on a daily basis. Patients who reported already walking 5 days/week for at least 30 min/day or otherwise being very active – such as, daily tennis or jogging or similar intensity physical activities – were excluded from the study. Written informed consent was secured from eligible patients before study procedures were implemented. The study protocol was approved by the University of North Carolina at Chapel Hill (UNC) Institutional Review Board and the UNC Lineberger Comprehensive Cancer Center Protocol Review Committee.
2.2.
Design and Procedures
The study design was a single-arm intervention trial for a preliminary pre–post assessment of the impact (Cohen's effect size)50 on feasibility and outcome measures, with data collected at baseline and 6-weeks follow-up (end of intervention). Participants received a copy of the walk with ease workbook,51 a 2-page insert by the study team titled “Walk With Ease for Women with Breast Cancer on Aromatase Inhibitor Therapy”, and a daily walking diary. Upon completion of all study requirements, participants received a summary of study findings and a $25 gift card.
2.3.
Physical Activity Intervention—Walk With Ease (WWE)
We chose a low-impact walking program as our intervention because walking is a preferred physical activity of older adults
150
J O U RN A L OF GE RI A TR I C O NC O LOG Y 5 ( 20 1 4 ) 1 4 8 –1 5 5
and has been shown to improve functional status in adults with arthritis without exacerbating pain.52–54 We specifically chose the WWE program because it has been proven effective in a self-directed format (as well as group) among communitydwelling adults with self-reported arthritis or joint pain/ stiffness to improve joint pain and symptoms as well as other outcome measures after the 6-week intervention.55 Improvements in outcomes were generally maintained at 1 year.55 While arthritis and AIA are not synonymous, our underlying assumption is that AIA symptoms could be mitigated by walking in a manner similar to arthritis joint pain and stiffness symptoms. The goal of WWE is to initiate or resume and sustain an ongoing lifestyle of physical activity by walking at least 5 days a week for at least 30 accumulated minutes per day, which is the 150 min of moderate physical activity per week recommended for adults of all ages.56 Essential elements of the WWE program are reflected in chapters of the WWE workbook and focus on arthritis symptom management through exercise and motivation/behavioral change strategies. The self-directed WWE format is easy to implement under real world conditions in clinic and community settings—there are no special facilities, equipment or personnel, and it is easy to explain and do under a wide variety of individual (personal) conditions and circumstances, and easily accessed (Arthritis Foundation). After the informed consenting process, it took the Study Team an average of no more than 5 min to explain to study participants the importance of walking, how to use the WWE workbook, and the value of maintaining a walking diary, including time for questions and answers. This time frame and level of effort on the part of the study team was intentional, in order to simulate real world time-restricted implementation conditions.
2.4.
In cancer research, VAS are commonly used measures for assessing pain intensity.60,61 The Arthritis Self-Efficacy Scale (ASE) 62,63 was used to measure the WWE program's impact on perceived ability to manage joint symptoms. With each item beginning with “How certain are you that you can ….”, ASE-Pain pertains to: decreasing arthritis or joint pain, continuing daily activities, pain interference with sleep, making a small to moderate reduction in pain using methods other than extra medication, and making a large reduction in pain using methods other than extra medication. In turn, ASE-Symptom pertains to: controlling fatigue, making yourself feel better when you are feeling blue, regulating your activity so as not to aggravate pain, dealing with frustrations of pain, managing pain during daily activities, and managing symptoms so that you can do things that you enjoy. Finally, information was collected to characterize the sample: age; race; education; body mass index (BMI); and breast cancer treatment (surgery, chemotherapy, radiation therapy, AI drug).
2.5.
Statistical Analysis
Descriptive statistics were used to calculate baseline mean values. T-tests were used to calculate differences in means between baseline and 6-week follow-up. Cohen's d effect size50,64 and correlation coefficients were used to assess the association between outcome measures and walking measures. Cohen's “rules of thumb” was used for the interpretation of Cohen's d effect sizes: small = 0.20, medium = 0.50, and large = 0.80. Similarly, our interpretation of the correlation coefficient (r) was: small = 0.10, medium = 0.25, and large = 0.43. All analyses were conducted using STATA Version 9.0.65
Measures
3. The primary outcomes of interest in this pilot study were the feasibility of (a) recruiting our target population of 20 women in a clinic setting within a limited time frame (5 months) and retaining at least 80% at 6 weeks, and2 (b) increasing walking among study participants for the duration of the 6-week program. Secondary outcomes of interest pertain to the promise of WWE (preliminary estimate of program impact) in our target population on: (a) joint symptoms (pain, stiffness and fatigue) and (b) self-efficacy in managing joint symptoms. With regard to walking behavior, we asked: “How many times a week do you go for a walk for at least 10 min, for any reason, in and around your neighborhood or elsewhere?” and “How much time (minutes) do you usually spend when you go for a walk in and around your neighborhood or elsewhere?” A composite variable was created by multiplying the number of times walked per week by the number of minutes per walk. WWE program impacts on joint symptoms were measured using 0–100 mm visual analog scales (VAS)—one each for pain, fatigue and stiffness.57–59 Pain scale: How much pain have you had because of your arthritis/joint condition over the past week— no pain to pain as bad as it could be. Fatigue scale: How much of a problem has unusual fatigue or tiredness been for you over the past week—fatigue is no problem to fatigue is a major problem. Stiffness scale: How much of a problem has stiffness been for you over the past week—no stiffness to stiffness as bad as it could be.
Results
A review of medical records for scheduled patients identified 61 potential participants—female patients with breast cancer, age 65 or older on AI therapy for 3 months or more. Treating clinicians determined that: (a) 7 patients (11%) had medical conditions that were too complex for a physical activity program, (b) 10 patients (16%) were not AI compliant (stopped or never started), and (c) 13 patients (21%) were not experiencing joint pain. Of the remaining 31 patients approached by the study team, 2 patients (6%) declined to participate and 5 (16%) were determined too physically active. Of the remaining 24 patients, 4 consented but then never started the study. Of the remaining 20 patients, 19 completed all study requirements (95%); see Fig. 1. Study participants (Table 1) were primarily Caucasian (85%) and well-educated (65% with more than a high school education), with mean age of 71 years and a mean BMI of 29. Ninety-three percent had a mastectomy; 57% had a prior lumpectomy, as well. A majority of participants were taking anastrozole (63%), followed by letrozole (53%) and exemestane (28%).
3.1.
Engagement in Walking
At baseline, engagement in walking averaged 3.5 (+ 2.9) times per week and 18.4 (+ 17.1) minutes per walk, with total minutes of walking per week averaging 94.6 (+ 113.7). At
151
J O U RN A L OF GE RI A T RI C O NC O L O G Y 5 ( 2 01 4 ) 1 4 8 – 15 5
increased by 8.3 (effect size = 0.48, p < 0.05), and total minutes per week increased by 62.6 (effect size = 0.53, p < 0.001) (see Fig. 2). At 6 weeks, 69% met the WWE goal of walking 5 days/ week, 62% the goal of 30 min/walk, and 50% the goal of 150 min/week. Overall, the proportion achieving the goal of 150 min of walking per week increased from 21% to 50%. On
61 potential patients identified in the electronic medical record– age 65+ on AIs
35 not eligible 13 no joint pain 10 not AI compliant 7 too medically complex 60
Number of Minutes per Walk
40
5 already walking the desired amount or physically very active
20
26 remaining eligible
0
2 declined to participate 4 consented but then did not start the program
Baseline
6 Weeks
20 started the program
10
19 completed the program
15
Number of Walks (Times) per Week 1 did not complete the program
baseline, 42% already met the WWE goal of walking 5 days/ week, 26% the goal of 30 min/walk, but only 21% the goal of 150 min/week. At 6 weeks, all three walking measures showed significant improvements: number of times increased by 1.9 (effect size = 0.68, p < 0.001), number of minutes
0
5
Fig. 1 – Consort diagram.
Baseline
6 Weeks
28% 53% 63% 29 (19–41)
400
62% 61% 57% 93%
200
71 (65–87) 35% 85%
0
Demographics Age (years), mean (range) Education,
