Moving Forward Together 4

NCT ID: NCT05409664

Last Updated: 2025-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-10

Study Completion Date

2026-01-31

Brief Summary

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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

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Conditions

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Breast Cancer Physical Inactivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Physical activity adoption

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Self monitoring

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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


* 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

Exclusion Criteria

* Stage 4 cancer
* Medical or psychiatric problem that may interfere with protocol adherence

Peer Mentor Coaches:
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role collaborator

Brown University

OTHER

Sponsor Role collaborator

InquisitHealth, Inc.

OTHER

Sponsor Role collaborator

University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Bernardine Pinto

Associate Dean for Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bernardine M. Pinto, PhD

Role: PRINCIPAL_INVESTIGATOR

University of South Carolina

Locations

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University of South Carolina

Columbia, South Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 41005365 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40423894 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38896452 (View on PubMed)

Other Identifiers

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Pro00117242

Identifier Type: -

Identifier Source: org_study_id

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