Promoting Activity in Cancer Survivors

Study Overview
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Brief Summary
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A randomized multi-component physical activity intervention for breast cancer survivors.

Detailed Description
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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.

Official Title
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Promoting Activity in Cancer Survivors

Conditions
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Physical Activity, Breast Cancer

Intervention / Treatment
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* Behavioral: Physical activity education
* Behavioral: Facility access
* Behavioral: Supervised exercise sessions
* Behavioral: Self-monitoring (Fitbit)
* Behavioral: Active living counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Physical activity education | Behavioral: Physical activity education<br>* Participants will be given educational materials on how to increase physical activity levels.<br>|
| Experimental: Group 2<br>Physical activity education and facility access | Behavioral: Physical activity education<br>* Participants will be given educational materials on how to increase physical activity levels.<br>Behavioral: Facility access<br>* Participants will receive at 6 month membership to a local fitness facility.<br>|
| Experimental: Group 3<br>Physical activity education and supervised exercise sessions | Behavioral: Physical activity education<br>* Participants will be given educational materials on how to increase physical activity levels.<br>Behavioral: Supervised exercise sessions<br>* Participants will attend weekly supervised exercise sessions with an exercise interventionist.<br>|
| Experimental: Group 4<br>Physical activity education and self-monitoring (Fitbit) | Behavioral: Physical activity education<br>* Participants will be given educational materials on how to increase physical activity levels.<br>Behavioral: Self-monitoring (Fitbit)<br>* Participants will be given a Fitbit to monitor their physical activity levels.<br>|
| Experimental: Group 5<br>Physical activity education and active living counseling | Behavioral: Physical activity education<br>* Participants will be given educational materials on how to increase physical activity levels.<br>Behavioral: Active living counseling<br>* Participants will attend 12 biweekly educational sessions about how to increase their physical activity levels.<br>|
| Experimental: Group 6<br>Physical activity education, facility access, and supervised exercise sessions | Behavioral: Physical activity education<br>* Participants will be given educational materials on how to increase physical activity levels.<br>Behavioral: Facility access<br>* Participants will receive at 6 month membership to a local fitness facility.<br>Behavioral: Supervised exercise sessions<br>* Participants will attend weekly supervised exercise sessions with an exercise interventionist.<br>|
| Experimental: Group 7<br>Physical activity education, facility access, and self-monitoring (Fitbit) | Behavioral: Physical activity education<br>* Participants will be given educational materials on how to increase physical activity levels.<br>Behavioral: Facility access<br>* Participants will receive at 6 month membership to a local fitness facility.<br>Behavioral: Self-monitoring (Fitbit)<br>* Participants will be given a Fitbit to monitor their physical activity levels.<br>|
| Experimental: Group 8<br>Physical activity education, facility access, and active living counseling | Behavioral: Physical activity education<br>* Participants will be given educational materials on how to increase physical activity levels.<br>Behavioral: Facility access<br>* Participants will receive at 6 month membership to a local fitness facility.<br>Behavioral: Active living counseling<br>* Participants will attend 12 biweekly educational sessions about how to increase their physical activity levels.<br>|
| Experimental: Group 9<br>Physical activity education, supervised exercise sessions, and self-monitoring (Fitbit) | Behavioral: Physical activity education<br>* Participants will be given educational materials on how to increase physical activity levels.<br>Behavioral: Supervised exercise sessions<br>* Participants will attend weekly supervised exercise sessions with an exercise interventionist.<br>Behavioral: Self-monitoring (Fitbit)<br>* Participants will be given a Fitbit to monitor their physical activity levels.<br>|
| Experimental: Group 10<br>Physical activity education, supervised exercise sessions, and active living counseling | Behavioral: Physical activity education<br>* Participants will be given educational materials on how to increase physical activity levels.<br>Behavioral: Supervised exercise sessions<br>* Participants will attend weekly supervised exercise sessions with an exercise interventionist.<br>Behavioral: Active living counseling<br>* Participants will attend 12 biweekly educational sessions about how to increase their physical activity levels.<br>|
| Experimental: Group 11<br>Physical activity education, self-monitoring (Fitbit), and active living counseling | Behavioral: Physical activity education<br>* Participants will be given educational materials on how to increase physical activity levels.<br>Behavioral: Self-monitoring (Fitbit)<br>* Participants will be given a Fitbit to monitor their physical activity levels.<br>Behavioral: Active living counseling<br>* Participants will attend 12 biweekly educational sessions about how to increase their physical activity levels.<br>|
| Experimental: Group 12<br>Physical activity education, facility access, supervised exercise sessions, and self-monitoring (Fitbit) | Behavioral: Physical activity education<br>* Participants will be given educational materials on how to increase physical activity levels.<br>Behavioral: Facility access<br>* Participants will receive at 6 month membership to a local fitness facility.<br>Behavioral: Supervised exercise sessions<br>* Participants will attend weekly supervised exercise sessions with an exercise interventionist.<br>Behavioral: Self-monitoring (Fitbit)<br>* Participants will be given a Fitbit to monitor their physical activity levels.<br>|
| Experimental: Group 13<br>Physical activity education, facility access, supervised exercise sessions, and active living counseling | Behavioral: Physical activity education<br>* Participants will be given educational materials on how to increase physical activity levels.<br>Behavioral: Facility access<br>* Participants will receive at 6 month membership to a local fitness facility.<br>Behavioral: Supervised exercise sessions<br>* Participants will attend weekly supervised exercise sessions with an exercise interventionist.<br>Behavioral: Active living counseling<br>* Participants will attend 12 biweekly educational sessions about how to increase their physical activity levels.<br>|
| Experimental: Group 14<br>Physical activity education, facility access, self-monitoring (Fitbit), and active living counseling | Behavioral: Physical activity education<br>* Participants will be given educational materials on how to increase physical activity levels.<br>Behavioral: Facility access<br>* Participants will receive at 6 month membership to a local fitness facility.<br>Behavioral: Self-monitoring (Fitbit)<br>* Participants will be given a Fitbit to monitor their physical activity levels.<br>Behavioral: Active living counseling<br>* Participants will attend 12 biweekly educational sessions about how to increase their physical activity levels.<br>|
| Experimental: Group 15<br>Physical activity education, supervised exercise sessions, self-monitoring (Fitbit), and active living counseling | Behavioral: Physical activity education<br>* Participants will be given educational materials on how to increase physical activity levels.<br>Behavioral: Supervised exercise sessions<br>* Participants will attend weekly supervised exercise sessions with an exercise interventionist.<br>Behavioral: Self-monitoring (Fitbit)<br>* Participants will be given a Fitbit to monitor their physical activity levels.<br>Behavioral: Active living counseling<br>* Participants will attend 12 biweekly educational sessions about how to increase their physical activity levels.<br>|
| Experimental: Group 16<br>Physical activity education, facility access, supervised exercise sessions, self-monitoring (Fitbit), and active living counseling | Behavioral: Physical activity education<br>* Participants will be given educational materials on how to increase physical activity levels.<br>Behavioral: Facility access<br>* Participants will receive at 6 month membership to a local fitness facility.<br>Behavioral: Supervised exercise sessions<br>* Participants will attend weekly supervised exercise sessions with an exercise interventionist.<br>Behavioral: Self-monitoring (Fitbit)<br>* Participants will be given a Fitbit to monitor their physical activity levels.<br>Behavioral: Active living counseling<br>* Participants will attend 12 biweekly educational sessions about how to increase their physical activity levels.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Moderate-to-vigorous physical activity measured by Actigraph accelerometer | 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. | 24 weeks |