Prostate Cancer Survivors and Exercise and Behavioral Counseling

NCT03191968 | Completed Phase 2

• 1 other identifier: IRB
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Physical Activity; Cancer of the Prostate; Cognitive Impairment; Quality of Life

Keywords

Behavior change; Prostate cancer; Behavioral counseling; Physical Activity; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Self-reported physical activity

  Change in from baseline at 12 weeks

• Physical Function

  Change in from baseline at 12 weeks

• General quality of life

  Change in from baseline at 12 weeks

• Prostate-specific quality of life

  Change in from baseline at 12 weeks

• Cancer-related fatigue

  Change in from baseline at 12 weeks

Study Arms (2)

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

Behavioral: Supervised Physical Activity Plus Behavioral Counseling

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.

Behavioral: Supervised Physical Activity Plus Exercise Counseling

Interventions

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

Supervised PA Plus Behavioral Counseling

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.

Supervised PA Plus Exercise Counseling

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead

Study Sites (1)

University of Illinois at Urbana-Champaign

Urbana, Illinois, 61801, United States

Location

Related Publications (13)

• 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.

  PMID: 18389368 BACKGROUND

• 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.

  PMID: 21640547 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.

  PMID: 22895961 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.

  PMID: 19274062 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.

  PMID: 25527697 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.

  PMID: 22539238 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.

  PMID: 20559064 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.

  PMID: 21989678 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.

  PMID: 18460985 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.

  PMID: 24232192 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.

  PMID: 23479546 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.

  PMID: 28169490 BACKGROUND

• 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.

  PMID: 32979134 DERIVED

MeSH Terms

Conditions

Motor Activity; Prostatic Neoplasms; Cognitive Dysfunction

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Behavior; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: June 19, 2017
• Study Start: July 6, 2017
• Primary Completion: May 30, 2018
• Study Completion: May 30, 2018
• Last Updated: December 20, 2019

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)