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This study will evaluate the feasibility of delivering a supervised physical activity program plus standard exercise counseling (SPA+EC) versus a supervised physical activity plus motivationally-enhanced behavioral counseling (SPA+BC) in prostate cancer survivors (PCS). Fifty participants (n=25) will be randomized to receiving SPA+EC or SPA+BC (n=25). We hypothesize that PCS receiving the SPA+BC intervention will result in greater increases in objectively-assessed physical activity compared with PCS receiving the SPA+EC intervention.
Physical activity (PA) has a positive impact on clinical outcomes such as improvement in overall QoL, cancer-specific mortality, reducing treatment-related toxicities, and reducing fatigue across many cancer survivor groups including PCS. Despite these benefits of regular PA, the majority of PCS are still not meeting public health PA guidelines.
Short-term supervised PA programs have been shown to improve health-related fitness and patient-reported outcomes in PCS, but PA declines significantly after the supervised intervention has been completed. Research examining the effect of short- term supervised exercise programs on motivational outcomes and longer term PA among cancer survivors is limited, especially theoretical approaches to identify key motivational outcomes for behavior change.
This study will pilot a two-armed, single blind, RCT comparing SPA+EC to SPA+BC. The proposed RCT in PCS is noteworthy given that it differs from standard approaches to supervised PA with the addition of a behavioral counseling component. This rigorous comparison condition will provide further evidence that theoretically-informed interventions are needed to adopt long-term PA maintenance.
The program's supervised exercise length will be 6 weeks, followed by a tapered contact throughout the a 6-week home-based component through 'booster' behavioral counseling delivered via telephone. In terms of study measures, objective measures of PA will be used (i.e.,accelerometry, inclinometers), and cardiorespiratory fitness will be evaluated using maximal graded exercise testing via treadmill. Additional secondary outcomes include cognitive function, quality of life, physical function, body composition, motivational outcomes, sexual functioning, masculinity, sedentary behavior, and cardiorespiratory fitness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supervised PA Plus Behavioral Counseling | Experimental | 25 prostate cancer survivors will receive supervised physical activity and behavioral counseling (SPA+BC) based on the M-PAC. In addition to supervised physical activity, behavioral counseling sessions will be delivered with a PA specialist based on the Multi-process Action Control (M-PAC) framework and include behavior change techniques addressing information regarding the consequences, social support, goal setting, self-monitoring, cues and prompts, barrier identification, intention formation, planning, and habit and identity formation |
|
| Supervised PA Plus Exercise Counseling | Active Comparator | 25 prostate cancer survivors will supervised physical activity and exercise counseling (SPA+EC).In addition to the supervised exercise sessions, standard exercise counseling will be delivered by a PA specialist to teach proper PA and resistance training techniques, how to monitor intensity, and to progress PA safely and effectively to achieve the public health PA guideline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supervised Physical Activity Plus Behavioral Counseling | Behavioral | In addition to supervised physical activity, behavioral counseling sessions will be delivered with a PA specialist based on the Multi-process Action Control (M-PAC) framework and include behavior change techniques addressing information regarding the consequences, social support, goal setting, self-monitoring, cues and prompts, barrier identification, intention formation, planning, and habit and identity formation |
| Measure | Description | Time Frame |
|---|---|---|
| Objectively assessed physical activity | Objective Physical activity will be measured using an activity device, accelerometry (i.e., Actigraph GTX3+) | Change in from baseline at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported physical activity | Self-reported physical activity will be assessed using the Godin Leisure-Time Exercise Questionnaire | Change in from baseline at 12 weeks |
| Physical Function | Mobility-related fitness parameters will be measured through the six-items of the Seniors' Fitness Test. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linda Trinh, PhD | University of Illinois at Urbana-Champaign | Principal Investigator |
| Edward McAuley, PhD | University of Illinois at Urbana-Champaign | Study Director |
| Art F Kramer, PhD | University of Illinois at Urbana-Champaign and Northeastern University | Study Director |
| Kendrith M Rowland, MD | Carle Cancer Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois at Urbana-Champaign | Urbana | Illinois | 61801 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18389368 | Background | Courneya KS, Friedenreich CM, Reid RD, Gelmon K, Mackey JR, Ladha AB, Proulx C, Vallance JK, Segal RJ. Predictors of follow-up exercise behavior 6 months after a randomized trial of exercise training during breast cancer chemotherapy. Breast Cancer Res Treat. 2009 Mar;114(1):179-87. doi: 10.1007/s10549-008-9987-3. Epub 2008 Apr 4. | |
| 21640547 |
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| Supervised Physical Activity Plus Exercise Counseling | Behavioral | In addition to the supervised exercise sessions, standard exercise counseling will be delivered by a PA specialist to teach proper PA and resistance training techniques, how to monitor intensity, and to progress PA safely and effectively to achieve the public health PA guideline. |
|
| Change in from baseline at 12 weeks |
| General quality of life | Self-reported quality of life measured via the Functional Assessment of Cancer Therapy (FACT-G) for general quality of life. | Change in from baseline at 12 weeks |
| Prostate-specific quality of life | Self-reported quality of life measured via the FACT-Prostate for prostate-specific quality of life. | Change in from baseline at 12 weeks |
| Cancer-related fatigue | Self-reported fatigue will be assessed using the FACT-Fatigue | Change in from baseline at 12 weeks |
| General well-being | Self-reported Short-Form 36 will be used for assessing general well-being. | Change in from baseline at 12 weeks |
| Body composition | Body composition will be estimated using anthropometric measurements will be taken - height, weight and waist circumference. | Change in from baseline at 12 weeks |
| Cardiorespiratory fitness | Aerobic endurance capacity will be assessed by using the modified Balke sub-maximual exercise test. | Change in from baseline at 12 weeks |
| Cognitive function | The primary set of neuropsychological assessments will be assessed using the validated NIH Toolbox Cognition Battery. This battery consists of tests to assess Executive Function, Attention, Episodic Memory, Language, Processing Speed and Working Memory. | Change in from baseline at 12 weeks |
| Sexual Health | The International Index of Erectile Function (IIEF) will be used to assess sexual health including erectile function, orgasmic function, sexual desire, intercourse satisfaction and overall satisfaction. | Change in from baseline at 12 weeks |
| Relationship quality | The Perceived Relationship Quality Components (PRQC) Inventory will be used to assess relationship quality. | Change in from baseline at 12 weeks |
| Masculine self-esteem | Masculine self-esteem will be assessed using the Masculinity in Chronic Disease Inventory (MCD-I). | Change in from baseline at 12 weeks |
| Motivational outcomes | multi-process action control (M-PAC) framework assessing attitudes, subjective norms, perceived behavioral control, planning, habit, and identity | Change in from baseline at 12 weeks |
| Self-reported sedentary behavior | sitting time as measured by via self-report using the Measuring Older Adults' Sedentary Time (MOST) questionnaire which assesses sitting while watching TV, using the computer, hobbies, socializing, transportation, doing hobbies, and other activities. | Change in from baseline at 12 weeks |
| Objectively assessed sedentary behavior | Objective measures of sitting time will be assessed using an activity device, inclinometers (i.e., ActivPALs) | Change in from baseline at 12 weeks |
| Keogh JW, MacLeod RD. Body composition, physical fitness, functional performance, quality of life, and fatigue benefits of exercise for prostate cancer patients: a systematic review. J Pain Symptom Manage. 2012 Jan;43(1):96-110. doi: 10.1016/j.jpainsymman.2011.03.006. Epub 2011 Jun 2. |
| 22895961 | Background | Mishra SI, Scherer RW, Geigle PM, Berlanstein DR, Topaloglu O, Gotay CC, Snyder C. Exercise interventions on health-related quality of life for cancer survivors. Cochrane Database Syst Rev. 2012 Aug 15;2012(8):CD007566. doi: 10.1002/14651858.CD007566.pub2. |
| 19274062 | Background | Antonelli J, Freedland SJ, Jones LW. Exercise therapy across the prostate cancer continuum. Prostate Cancer Prostatic Dis. 2009;12(2):110-5. doi: 10.1038/pcan.2009.4. Epub 2009 Mar 10. |
| 25527697 | Background | Bonn SE, Sjolander A, Lagerros YT, Wiklund F, Stattin P, Holmberg E, Gronberg H, Balter K. Physical activity and survival among men diagnosed with prostate cancer. Cancer Epidemiol Biomarkers Prev. 2015 Jan;24(1):57-64. doi: 10.1158/1055-9965.EPI-14-0707. Epub 2014 Dec 19. |
| 22539238 | Background | Rock CL, Doyle C, Demark-Wahnefried W, Meyerhardt J, Courneya KS, Schwartz AL, Bandera EV, Hamilton KK, Grant B, McCullough M, Byers T, Gansler T. Nutrition and physical activity guidelines for cancer survivors. CA Cancer J Clin. 2012 Jul-Aug;62(4):243-74. doi: 10.3322/caac.21142. Epub 2012 Apr 26. |
| 20559064 | Background | Schmitz KH, Courneya KS, Matthews C, Demark-Wahnefried W, Galvao DA, Pinto BM, Irwin ML, Wolin KY, Segal RJ, Lucia A, Schneider CM, von Gruenigen VE, Schwartz AL; American College of Sports Medicine. American College of Sports Medicine roundtable on exercise guidelines for cancer survivors. Med Sci Sports Exerc. 2010 Jul;42(7):1409-26. doi: 10.1249/MSS.0b013e3181e0c112. |
| 21989678 | Background | Baumann FT, Zopf EM, Bloch W. Clinical exercise interventions in prostate cancer patients--a systematic review of randomized controlled trials. Support Care Cancer. 2012 Feb;20(2):221-33. doi: 10.1007/s00520-011-1271-0. Epub 2011 Oct 12. |
| 18460985 | Background | Courneya KS, Segal RJ, Gelmon K, Reid RD, Mackey JR, Friedenreich CM, Proulx C, Lane K, Ladha AB, Vallance JK, McKenzie DC. Predictors of supervised exercise adherence during breast cancer chemotherapy. Med Sci Sports Exerc. 2008 Jun;40(6):1180-7. doi: 10.1249/MSS.0b013e318168da45. |
| 24232192 | Background | Trinh L, Plotnikoff RC, Rhodes RE, North S, Courneya KS. Feasibility and preliminary efficacy of adding behavioral counseling to supervised physical activity in kidney cancer survivors: a randomized controlled trial. Cancer Nurs. 2014 Sep-Oct;37(5):E8-22. doi: 10.1097/NCC.0b013e3182a40fb6. |
| 23479546 | Background | Weintraub S, Dikmen SS, Heaton RK, Tulsky DS, Zelazo PD, Bauer PJ, Carlozzi NE, Slotkin J, Blitz D, Wallner-Allen K, Fox NA, Beaumont JL, Mungas D, Nowinski CJ, Richler J, Deocampo JA, Anderson JE, Manly JJ, Borosh B, Havlik R, Conway K, Edwards E, Freund L, King JW, Moy C, Witt E, Gershon RC. Cognition assessment using the NIH Toolbox. Neurology. 2013 Mar 12;80(11 Suppl 3):S54-64. doi: 10.1212/WNL.0b013e3182872ded. |
| 28169490 | Background | Treanor CJ, Li J, Donnelly M. Cognitive impairment among prostate cancer patients: An overview of reviews. Eur J Cancer Care (Engl). 2017 Nov;26(6). doi: 10.1111/ecc.12642. Epub 2017 Feb 7. |
| 32979134 | Derived | Trinh L, Kramer AF, Rowland K, Strom DA, Wong JN, McAuley E. A pilot feasibility randomized controlled trial adding behavioral counseling to supervised physical activity in prostate cancer survivors: behavior change in prostate cancer survivors trial (BOOST). J Behav Med. 2021 Apr;44(2):172-186. doi: 10.1007/s10865-020-00185-8. Epub 2020 Sep 26. |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D011471 | Prostatic Neoplasms |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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