Prostate Cancer Survivors and Exercise and Behavioral Counseling

Quality of Life Clinical Trial

— BOOST  

Official title:

A Pilot, Randomized Controlled Trial Adding Behavioral Counseling to Supervised Physical Activity in Prostate Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03191968
• Other study ID #: IRB
• Status: Completed
• Phase: Phase 2
• Start date: July 6, 2017
• Est. completion date: May 30, 2018

Study information

• Verified date: April 2017
• Source: University of Illinois at Urbana-Champaign
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: May 30, 2018
• Est. primary completion date: May 30, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• =18 years and older

• Histologically confirmed prostate cancer (Stage I-IIIa) but now cured or in remission

• Ability and willingness to effectively communicate in English

• Not meeting physical activity guidelines of =150 minutes of vigorous physical activity

Exclusion Criteria:

• Severe coronary artery disease (Canadian Cardiovascular Society class III or greater)

• Significant congestive heart failure (New York Heart Association class III or greater)

• Uncontrolled pain

• Neurological or musculoskeletal co-morbidity inhibiting exercise

• Diagnosed psychotic, addictive or major cognitive disorders

• Absent for more than 3 consecutive days during the 12-week intervention

• High risk individuals (i.e., men who have symptomatic and known cardiovascular, pulmonary and/or metabolic disease) as determined by the risk stratification questionnaire

Related Conditions & MeSH terms

• Cancer of the Prostate
• Cognitive Dysfunction
• Cognitive Impairment
• Physical Activity
• Prostatic Neoplasms
• Quality of Life

Intervention

Behavioral:
• Supervised Physical Activity Plus Behavioral Counseling
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 Physical Activity Plus Exercise Counseling
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.

Locations

Country	Name	City	State
United States	University of Illinois at Urbana-Champaign	Urbana	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. Review. — View Citation

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. Review. — View Citation

Bonn SE, Sjölander A, Lagerros YT, Wiklund F, Stattin P, Holmberg E, Grönberg H, Bälter 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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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;(8):CD007566. doi: 10.1002/14651858.CD007566.pub2. Review. — View Citation

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. Review. Erratum in: CA Cancer J Clin. 2013 May;63(3):215. — View Citation

Schmitz KH, Courneya KS, Matthews C, Demark-Wahnefried W, Galvão 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. Erratum in: Med Sci Sports Exerc. 2011 Jan;43(1):195. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Physical Function	Mobility-related fitness parameters will be measured through the six-items of the Seniors' Fitness Test.	Change in from baseline at 12 weeks
Secondary	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
Secondary	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
Secondary	Cancer-related fatigue	Self-reported fatigue will be assessed using the FACT-Fatigue	Change in from baseline at 12 weeks
Secondary	General well-being	Self-reported Short-Form 36 will be used for assessing general well-being.	Change in from baseline at 12 weeks
Secondary	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
Secondary	Cardiorespiratory fitness	Aerobic endurance capacity will be assessed by using the modified Balke sub-maximual exercise test.	Change in from baseline at 12 weeks
Secondary	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
Secondary	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
Secondary	Relationship quality	The Perceived Relationship Quality Components (PRQC) Inventory will be used to assess relationship quality.	Change in from baseline at 12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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