Improving Physical Activity Maintenance of Cancer Survivors

NCT ID: NCT03976193

Last Updated: 2023-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2022-10-25

Brief Summary

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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

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Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type PLACEBO_COMPARATOR

BfitBwell program

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

BfitBwell program

Intervention Type BEHAVIORAL

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

6 bi-weekly PA Behavior Change counseling sessions

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UCD Anschutz Health and Wellness Center

Aurora, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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P30CA046934

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19-0323.cc

Identifier Type: -

Identifier Source: org_study_id

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