Moving Forward Together 4

Study Overview
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Brief Summary
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This is a 3-month physical activity intervention aimed to increase moderate-intensity activity among previously inactive breast cancer survivors. Participants will be eligible if they are not currently active, and have recently been diagnosed with breast cancer. Upon eligibility, participants will be randomized into one of two groups. The intervention group will receive weekly guidance from a peer coach to increase their activity throughout the three month intervention. The control group will be encouraged to self-monitor their physical activity throughout the three month intervention. Both groups will receive a Fitbit. Peer coaches will be trained to deliver the physical activity program using a web-based platform; all calls will be virtual. Participants will be assessed before and after the intervention.

Official Title
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Peer Coaching for Physical Activity Promotion Among Breast Cancer Survivors: Adapting an Efficacious Intervention to Prepare for Implementation

Conditions
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Breast Cancer, Physical Inactivity

Intervention / Treatment
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* Behavioral: Physical activity adoption
* Behavioral: Self monitoring


Participation Criteria
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Eligibility Criteria
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Participants: Inclusion Criteria: Diagnosed in the past 5 years with Stage 0-3 breast cancer Able to read and speak English Ambulatory Sedentary (<30 minutes of vigorous-intensity physical activity, <90 min of moderate-intensity physical activity in the past 6 months) Able to walk unassisted Access to a smartphone with Bluetooth and internet Exclusion Criteria: Stage 4 cancer Medical or psychiatric problem that may interfere with protocol adherence Peer Mentor Coaches: Inclusion criteria: Current peer coach (at least one year) Have a valid email address, telephone access, and access to a tablet/computer Willing to participate in group training Willing to be supervised using platform Currently exercise for at least 60 min/week of moderate-intensity activity

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a randomized controlled trial. Participants will be randomly assigned to a intervention group or a control group. The study duration will be 3-months for both groups; assessments will be completed pre- and post-intervention.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: webMFT<br>Survivors randomized to webMFT will receive the evidence-based intervention for moderate-to-vigorous physical activity (MVPA) promotion that consists of MVPA counseling matched to patients' motivational readiness, and self-monitoring of MVPA (via Fitbit Inspire 2). The goal for the 3-month program will be to gradually increase the amount of moderate-intensity aerobic exercise that is performed, to the current national recommendations of at least 150 minutes of MPVA per week. Our goal is to promote aerobic exercise that is safe and enjoyable, such as walking. | Behavioral: Physical activity adoption<br>* webMFT will be delivered via a web-based platform. Coaches will be trained to deliver the intervention prior to being assigned a study participant. Upon successful completion of the informed consent for coaches and participants, coaches will be assigned a participant for their 3-month duration in the study. Coaches and participants will complete weekly phone calls focused on increasing the participants' MVPA up to the recommended 150 min/week.<br>|
| Active Comparator: MVPA tracking<br>These survivors will be asked to self-monitor moderate-to-vigorous physical activity (MVPA) participation by wearing the Fitbit Inspire 2 each day over 12 weeks. This group will not receive the MVPA counseling from the coaches. | Behavioral: Self monitoring<br>* Participants will be asked to gradually increase their activity up to the recommended 150 minutes of moderate-intensity/week during the 12-week intervention. Self-monitoring will be completed using a Fitbit tracker.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accelerometer measured moderate-to-vigorous activity | Minutes of moderate-to-vigorous intensity activity at 3-month follow-up | 3-month intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-Reported Quality of Life | Assessed via FACT-B, validated questionnaire | Pre-intervention and post 3-month intervention | 
| Self-Reported Physical Functioning | Assessed via SF-36, validated questionnaire | Pre-intervention and post 3-month intervention | 
| Self-Reported Mood | Assessed via Profile of Mood States, validated questionnaire | Pre-intervention and post 3-month intervention | 
| Self-Reported Fatigue | Assessed via FACIT-F, validated questionnaire | Pre-intervention and post 3-month intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peer support