Moving Forward Together 4

Breast Cancer Clinical Trial

— MFT4  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05409664
• Other study ID #: Pro00117242
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 10, 2022
• Est. completion date: January 31, 2025

Study information

• Verified date: December 2023
• Source: University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 68
• Est. completion date: January 31, 2025
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Physical Inactivity

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of South Carolina	Columbia	South Carolina

Sponsors (4)

Lead Sponsor	Collaborator
University of South Carolina	Brown University, InquisitHealth, Inc., University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accelerometer measured moderate-to-vigorous activity	Minutes of moderate-to-vigorous intensity activity at 3-month follow-up	3-month intervention
Secondary	Self-Reported Quality of Life	Assessed via FACT-B, validated questionnaire	Pre-intervention and post 3-month intervention
Secondary	Self-Reported Physical Functioning	Assessed via SF-36, validated questionnaire	Pre-intervention and post 3-month intervention
Secondary	Self-Reported Mood	Assessed via Profile of Mood States, validated questionnaire	Pre-intervention and post 3-month intervention
Secondary	Self-Reported Fatigue	Assessed via FACIT-F, validated questionnaire	Pre-intervention and post 3-month intervention