Improving Physical Activity Maintenance of Cancer Survivors
October 16, 2023 updated by: University of Colorado, Denver
Improving Physical Activity Maintenance Following an Exercise Program for Cancer Survivors
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- UCD Anschutz Health and Wellness Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- current patient at the University of Colorado Cancer Center
- signed physician clearance to participate in a supervised exercise program
- participant is actively receiving medical cancer treatment (chemotherapy, radiation or surgery) OR within 6 months of receiving medical cancer treatment.
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
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.
|
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
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2019
Primary Completion (Actual)
September 1, 2020
Study Completion (Actual)
October 25, 2022
Study Registration Dates
First Submitted
May 22, 2019
First Submitted That Met QC Criteria
June 4, 2019
First Posted (Actual)
June 5, 2019
Study Record Updates
Last Update Posted (Actual)
October 17, 2023
Last Update Submitted That Met QC Criteria
October 16, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 19-0323.cc
- P30CA046934 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.