Moving Forward Together 4

Not Applicable

Active, not recruiting

• Conditions: Breast Cancer; Physical Inactivity
• Interventions: Behavioral: Physical activity adoption; Behavioral: Self monitoring

• Registration Number: NCT05409664
• Lead Sponsor: University of South Carolina

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-12
• Study First Submitted QC: 2022-06-03
• Study First Posted: 2022-06-08
• Study Start: 2022-11-10
• Status Verified: 2025-05
• Primary Completion: 2025-05-01
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 68

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
webMFT	Physical activity adoption	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.
MVPA tracking	Self monitoring	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.

Primary Outcome Measures

Name	Time	Method
Accelerometer measured moderate-to-vigorous activity	3-month intervention	Minutes of moderate-to-vigorous intensity activity at 3-month follow-up

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of South Carolina; 🇺🇸 Columbia, South Carolina, United States