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Moving Forward Together 4 (MFT4)

Primary Purpose

Breast Cancer, Physical Inactivity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical activity adoption
Self monitoring
Sponsored by
University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Cancer focused on measuring Peer support

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of South CarolinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

webMFT

MVPA tracking

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Self-Reported Quality of Life
Assessed via FACT-B, validated questionnaire
Self-Reported Physical Functioning
Assessed via SF-36, validated questionnaire
Self-Reported Mood
Assessed via Profile of Mood States, validated questionnaire
Self-Reported Fatigue
Assessed via FACIT-F, validated questionnaire

Full Information

First Posted
May 12, 2022
Last Updated
December 15, 2022
Sponsor
University of South Carolina
Collaborators
University of Colorado, Denver, Brown University, InquisitHealth, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05409664
Brief Title
Moving Forward Together 4
Acronym
MFT4
Official Title
Peer Coaching for Physical Activity Promotion Among Breast Cancer Survivors: Adapting an Efficacious Intervention to Prepare for Implementation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Carolina
Collaborators
University of Colorado, Denver, Brown University, InquisitHealth, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Physical Inactivity
Keywords
Peer support

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
webMFT
Arm Type
Experimental
Arm Description
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.
Arm Title
MVPA tracking
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Physical activity adoption
Intervention Description
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
Intervention Name(s)
Self monitoring
Intervention Description
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 Outcome Measure Information:
Title
Accelerometer measured moderate-to-vigorous activity
Description
Minutes of moderate-to-vigorous intensity activity at 3-month follow-up
Time Frame
3-month intervention
Secondary Outcome Measure Information:
Title
Self-Reported Quality of Life
Description
Assessed via FACT-B, validated questionnaire
Time Frame
Pre-intervention and post 3-month intervention
Title
Self-Reported Physical Functioning
Description
Assessed via SF-36, validated questionnaire
Time Frame
Pre-intervention and post 3-month intervention
Title
Self-Reported Mood
Description
Assessed via Profile of Mood States, validated questionnaire
Time Frame
Pre-intervention and post 3-month intervention
Title
Self-Reported Fatigue
Description
Assessed via FACIT-F, validated questionnaire
Time Frame
Pre-intervention and post 3-month intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Madison Kindred, PhD
Phone
803-777-7608
Email
demello@email.sc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernardine M. Pinto, PhD
Organizational Affiliation
University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Carolina
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madison Kindred, PhD
First Name & Middle Initial & Last Name & Degree
Bernardine M Pinto, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data can be shared upon request.

Learn more about this trial

Moving Forward Together 4

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