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Improving Physical Activity Maintenance of Cancer Survivors

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ClinicalTrials.gov Identifier: NCT03976193
Recruitment Status : Completed
First Posted : June 5, 2019
Last Update Posted : April 29, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date  ICMJE May 22, 2019
First Posted Date  ICMJE June 5, 2019
Last Update Posted Date April 29, 2021
Actual Study Start Date  ICMJE June 1, 2019
Actual Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2019)
Examine the effects of six, group-based physical activity (PA) behavior change counseling sessions PA change from post-program, to 3-months following completion of the BfitBwell program. [ Time Frame: 3 months ]
The primary outcome will be self-reported weekly minutes of moderate to vigorous leisure-time PA, three-months following completion of the program, measured by the Godin Shepherd Leisure Time Exercise Questionnaire
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Improving Physical Activity Maintenance of Cancer Survivors
Official Title  ICMJE Improving Physical Activity Maintenance Following an Exercise Program for Cancer Survivors
Brief Summary Participants enrolled in the BfitBwell Cancer Exercise Program at the University of Colorado Cancer Center will be randomized 1:1 to receive the current BfitBwell program, or BfitBwell plus six, group-based behavior change counseling sessions adapted from BEAT Cancer. We will stratify the randomization based on sex.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Cancer
Intervention  ICMJE
  • Behavioral: BfitBwell program
    Well known behavior change strategies such as goal setting, and identifying barriers to PA can improve long term adherence to PA, and have been shown to enhance PA maintenance after completion of a supervised intervention among cancer survivors
  • Behavioral: 6 bi-weekly PA Behavior Change counseling sessions
    Well known behavior change strategies such as goal setting, and identifying barriers to PA can improve long term adherence to PA, and have been shown to enhance PA maintenance after completion of a supervised intervention among cancer survivors
Study Arms  ICMJE
  • Placebo Comparator: BfitBwell program
    BfitBwell is a 3-month supervised exercise program for cancer survivors delivered at the Anschutz Health and Wellness Center. This program has demonstrated effectiveness for improving physical fitness, fatigue, and depression among participants
    Intervention: Behavioral: BfitBwell program
  • Active Comparator: BfitBwell + 6, bi-weekly PA Behavior Change counseling session
    Participants randomized to BfitBwell + PA behavior change counseling sessions will receive six, 1-1.5 hour sessions lead by a Certified Exercise Physiologist, trained on the study protocol. Sessions will be held once per week, every other week at the Anschutz Health and Wellness center. Participants will attend the sessions in groups, as schedules allow. Behavior change discussion topics will target self-efficacy for exercise, barriers to exercise, goal setting, behavior modification strategies, time management, cognitive reframing, and relapse prevention. Participants in this study arm will receive a group education workbook in congruence to discussion session topics to promote notetaking, and self-reflective journaling.
    Interventions:
    • Behavioral: BfitBwell program
    • Behavioral: 6 bi-weekly PA Behavior Change counseling sessions
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 28, 2021)
33
Original Estimated Enrollment  ICMJE
 (submitted: June 4, 2019)
60
Actual Study Completion Date  ICMJE September 1, 2020
Actual Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. current patient at the University of Colorado Cancer Center
  2. signed physician clearance to participate in a supervised exercise program
  3. participant is actively receiving medical cancer treatment (chemotherapy, radiation or surgery) OR within 6 months of receiving medical cancer treatment.
  4. Willingness to be randomized to receive six, PA behavior change counseling sessions as part of the BfitBwell program, and able to attend five out of six of these sessions
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03976193
Other Study ID Numbers  ICMJE 19-0323.cc
P30CA046934 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Colorado, Denver
Study Sponsor  ICMJE University of Colorado, Denver
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE Not Provided
PRS Account University of Colorado, Denver
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP