Moving Forward Together 4 (MFT4)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer; Physical Inactivity
• Intervention / Treatment: Behavioral: Physical activity adoption; Behavioral: Self monitoring

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Columbia, South Carolina, United States, 29208
      • University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: webMFT; 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; 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.
Active Comparator: MVPA tracking; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of South Carolina
• Collaborators: University of Colorado, Denver; Brown University; InquisitHealth, Inc.
• Investigators: Principal Investigator: Bernardine M. Pinto, PhD, University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2022
• Primary Completion (Actual): May 1, 2025
• Study Completion (Estimated): January 31, 2026

Study Registration Dates

• First Submitted: May 12, 2022
• First Submitted That Met QC Criteria: June 3, 2022
• First Posted (Actual): June 8, 2022

Study Record Updates

• Last Update Posted (Actual): May 15, 2025
• Last Update Submitted That Met QC Criteria: May 12, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Peer support
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: Pro00117242

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data can be shared upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No