Breast CancerMFT4NCT05409664
Moving Forward Together 4
A study testing Physical activity adoption and Self monitoring in people with Breast Cancer and Physical Inactivity, run by University of South Carolina at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Physical Inactivity
- What is being tested?
- Physical activity adoption and Self monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2022to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- Stage 4 cancer
- Medical or psychiatric problem that may interfere with protocol adherence
- Peer Mentor Coaches:
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina
Columbia, South Carolina, 29208
About this study
Official title: Peer Coaching for Physical Activity Promotion Among Breast Cancer Survivors: Adapting an Efficacious Intervention to Prepare for Implementation
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
- Being tested
- Physical activity adoption, Self monitoring
- Keywords
- Peer support
- Medical subject headings
- Breast Neoplasms, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity adoptionBehavioural
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 monitoringBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Self monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accelerometer measured moderate-to-vigorous activity
Minutes of moderate-to-vigorous intensity activity at 3-month follow-up
Measured: 3-month intervention
Secondary outcomes (4)
Self-Reported Quality of Life
Assessed via FACT-B, validated questionnaire
Measured: Pre-intervention and post 3-month intervention
Self-Reported Physical Functioning
Assessed via SF-36, validated questionnaire
Measured: Pre-intervention and post 3-month intervention
Self-Reported Mood
Assessed via Profile of Mood States, validated questionnaire
Measured: Pre-intervention and post 3-month intervention
Self-Reported Fatigue
Assessed via FACIT-F, validated questionnaire
Measured: Pre-intervention and post 3-month intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start10 Nov 2022
- Primary completion1 May 2025
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver, Brown University, InquisitHealth, Inc.
- Responsible party
- Principal investigator, Bernardine Pinto, University of South Carolina
- Investigators
- Bernardine M. Pinto, PhD, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05409664
- Sponsor's protocol ID
- Pro00117242
- Acronym
- MFT4
- Status last verified
- May 2025
- First submitted
- 12 May 2022
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data can be shared upon request.
Publications
Chen BK, Kindred MM, Ostendorf DM, Huebschmann A, Patel A, Dunsiger S, Pinto BM. Cost-effectiveness of a web-based peer-delivered physical activity program for breast cancer survivors. Transl Behav Med. 2026 Jan 7;16(1):ibag067. doi: 10.1093/tbm/ibag067.
PubMed 42811427Ostendorf 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.
PubMed 41005365Pinto 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.
PubMed 40423894Pinto 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.
PubMed 38896452
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer Coaching for Physical Activity Promotion Among Breast Cancer Survivors: Adapting an Efficacious Intervention to Prepare for Implementation
- ClinicalTrials.gov ID
- NCT05409664
- Acronym / sponsor ID
- MFT4 / Pro00117242
- Conditions
- Breast Cancer, Physical Inactivity
- Keywords
- Peer support
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- University of Colorado, Denver, Brown University, InquisitHealth, Inc.
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 8 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| webMFT | Experimental | Behavioral: Physical activity adoptionSurvivors 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. |
| MVPA tracking | Active comparator | Behavioral: Self monitoringThese 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (3 listed)
- Stage 4 cancer
- Medical or psychiatric problem that may interfere with protocol adherence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity adoptionwebMFT 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. | Behavioural | webMFT |
| Self monitoringParticipants 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. | Behavioural | MVPA tracking |
Primary outcome
Accelerometer measured moderate-to-vigorous activity
Time frame: 3-month intervention
Minutes of moderate-to-vigorous intensity activity at 3-month follow-up
4 secondary outcomes
Self-Reported Quality of Life
Time frame: Pre-intervention and post 3-month intervention
Self-Reported Physical Functioning
Time frame: Pre-intervention and post 3-month intervention
Self-Reported Mood
Time frame: Pre-intervention and post 3-month intervention
Self-Reported Fatigue
Time frame: Pre-intervention and post 3-month intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Derived from this study: PubMed 42811427Chen BK, Kindred MM, Ostendorf DM, Huebschmann A, Patel A, Dunsiger S, Pinto BM. Cost-effectiveness of a web-based peer-delivered physical activity program for breast cancer survivors. Transl Behav Med. 2026 Jan 7;16(1):ibag067. doi: 10.1093/tbm/ibag067.
- Derived from this study: PubMed 41005365Ostendorf 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.
- Derived from this study: PubMed 40423894Pinto 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.
- Derived from this study: PubMed 38896452Pinto 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.
- Individual participant dataSharing planned: Yes. Data can be shared upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernardine M. Pinto, PhD principal investigator
University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity adoption and Self monitoring in people with Breast Cancer and Physical Inactivity, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accelerometer measured moderate-to-vigorous activity (time frame: 3-month intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05409664, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025; AzTrials last refreshed its copy on 28 Oct 2026.