Moving Forward Together 4

NCT05409664 | Active Not Recruiting

• 1 other identifier: Pro00117242
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Physical Inactivity

Keywords

Peer support

Outcome Measures

Primary Outcomes (1)

• Accelerometer measured moderate-to-vigorous activity

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

  3-month intervention

Secondary Outcomes (4)

• Self-Reported Quality of Life

  Pre-intervention and post 3-month intervention

• Self-Reported Physical Functioning

  Pre-intervention and post 3-month intervention

• Self-Reported Mood

  Pre-intervention and post 3-month intervention

• Self-Reported Fatigue

  Pre-intervention and post 3-month intervention

Study Arms (2)

webMFT

EXPERIMENTAL

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

MVPA tracking

ACTIVE COMPARATOR

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

Interventions

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.

webMFT

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.

MVPA tracking

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Stage 4 cancer
• Medical or psychiatric problem that may interfere with protocol adherence
• Peer Mentor Coaches:
• 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

Sponsors & Collaborators

• University of South Carolina: lead
• University of Colorado, Denver: collaborator
• Brown University: collaborator
• InquisitHealth, Inc.: collaborator

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

Related Publications (3)

• Ostendorf DM, Huebschmann AG, Wickersham KE, Kindred M, Pinto BM. Adopting and implementing an efficacious peer-delivered physical activity program for web platform delivery in survivors of breast cancer: organizational readiness and perspectives. Transl Behav Med. 2025 Jan 16;15(1):ibaf051. doi: 10.1093/tbm/ibaf051.

  PMID: 41005365 DERIVED

• Pinto BM, Kindred M, Dunsiger S, Mitchell S, Patel A, Ostendorf D, Huebschmann AG. Effects of web platform delivery of a physical activity program for breast cancer survivors: a randomized controlled trial. J Cancer Surviv. 2025 May 27. doi: 10.1007/s11764-025-01811-7. Online ahead of print.

  PMID: 40423894 DERIVED

• Pinto BM, Patel A, Ostendorf DM, Huebschmann AG, Dunsiger SI, Kindred MM. Adapting an Efficacious Peer-Delivered Physical Activity Program for Survivors of Breast Cancer for Web Platform Delivery: Protocol for a 2-Phase Study. JMIR Res Protoc. 2024 Jun 19;13:e52494. doi: 10.2196/52494.

  PMID: 38896452 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Sedentary Behavior

Interventions

Blood Glucose Self-Monitoring

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Self-Testing; Self Care; Therapeutics; Investigative Techniques

Study Officials

• Bernardine M. Pinto, PhD

  University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Dean for Research

Model Details: 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.

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: June 8, 2022
• Study Start: November 10, 2022
• Primary Completion: May 1, 2025
• Study Completion: January 31, 2026
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)