Breast Cancer, Physical Activity
Conditions
Brief summary
A randomized multi-component physical activity intervention for breast cancer survivors.
Detailed description
The research project is a study to assess the effects of a multi-component intervention in increasing physical activity among breast cancer survivors. Individuals meeting inclusion/exclusion criteria will be randomized to one of sixteen intervention groups for the 6 months. Intervention components will include print-based education, self-monitoring, Active Living counseling, supervised exercise sessions, and facility access. Blood samples will be collected at baseline. Assessments (anxiety, stress, sleep) and sample collection will also occur at 3 time points during the intervention (Weeks 13 and 25). Changes in physical activity will be assessed for each intervention group.
Interventions
BEHAVIORALPhysical activity education
Participants will be given educational materials on how to increase physical activity levels.
BEHAVIORALFacility access
Participants will receive at 6 month membership to a local fitness facility.
BEHAVIORALSupervised exercise sessions
Participants will attend weekly supervised exercise sessions with an exercise interventionist.
BEHAVIORALSelf-monitoring (Fitbit)
Participants will be given a Fitbit to monitor their physical activity levels.
BEHAVIORALActive living counseling
Participants will attend 12 biweekly educational sessions about how to increase their physical activity levels.
Sponsors
Cancer Prevention Research Institute of Texas
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
The 500 participants in the physical activity intervention will be randomly assigned to one of sixteen intervention groups (see Table below). Randomization will be stratified by clinical site. The randomization scheme will be conducted by the study statistician. The randomization scheme will consist of balanced blocks within each stratum, with block size will be varied and randomly permuted. Allocation will occur following completion of baseline assessments.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* breast cancer survivors between 3 months and 5 years post-treatment * report \<150 minutes of moderate-to-vigorous physical activity (MVPA) on the GPAQ * physically able to engage in physical activity
Exclusion criteria
* medical condition contraindicating physical activity participation * cognitively unable to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Moderate-to-vigorous physical activity measured by Actigraph accelerometer | 24 weeks | Measure physical activity at baseline and follow-up periods (3- and 6-months post-baseline) and assess percentage of survivors meeting physical activity guideline recommendations. |
Countries
United States
Outcome results
None listed