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Active, Not Recruiting

NCT Number: NCT05409664

Moving Forward Together 4

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Breast Cancer Behavior Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Physical Inactivity Sedentary Behavior Skin Diseases Skin and Connective Tissue Diseases

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of South Carolina

Columbia, South Carolina, 29208, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical activity adoption

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Accelerometer measured moderate-to-vigorous activity

    Time frame: 3-month intervention

    Minutes of moderate-to-vigorous intensity activity at 3-month follow-up

Secondary outcomes

  1. Self-Reported Quality of Life

    Time frame: Pre-intervention and post 3-month intervention

    Assessed via FACT-B, validated questionnaire

  2. Self-Reported Physical Functioning

    Time frame: Pre-intervention and post 3-month intervention

    Assessed via SF-36, validated questionnaire

  3. Self-Reported Mood

    Time frame: Pre-intervention and post 3-month intervention

    Assessed via Profile of Mood States, validated questionnaire

  4. Self-Reported Fatigue

    Time frame: Pre-intervention and post 3-month intervention

    Assessed via FACIT-F, validated questionnaire

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Collaborators

  • Brown University
  • InquisitHealth, Inc.
  • University of Colorado, Denver

Registry information

Official study title

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

Acronym: MFT4

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jun 8, 2022
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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