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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

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.

Condition or disease Intervention/treatment Phase
Cancer Behavioral: BfitBwell program Behavioral: 6 bi-weekly PA Behavior Change counseling sessions Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Improving Physical Activity Maintenance Following an Exercise Program for Cancer Survivors
Actual Study Start Date : June 1, 2019
Actual Primary Completion Date : September 1, 2020
Actual Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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

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.
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




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03976193


Locations
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United States, Colorado
UCD Anschutz Health and Wellness Center
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
National Cancer Institute (NCI)
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03976193    
Other Study ID Numbers: 19-0323.cc
P30CA046934 ( U.S. NIH Grant/Contract )
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: April 29, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Colorado, Denver:
active treatment
Recent treatment