Breast CancerMFT2NCT00948701
Community Volunteers Promoting Physical Activity Among Cancer Survivors
A study testing Moving Forward Together 2 in people with Breast Cancer, run by The Miriam Hospital at 1 site in United States.
Trial summary
Physical activity programs, when offered in research settings, have been shown to improve quality of life and reduce fatigue among breast cancer survivors. The investigators are training Reach to Recovery volunteers at the American Cancer Society (New England Division) to provide a 12-week telephone-based physical… 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
- What is being tested?
- Moving Forward Together 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Women aged 21 years or over with Stage 0-3 breast cancer will be eligible if they:
- Are requesting Reach to Recovery services from the American Cancer Society.
- Have been diagnosed in the past 5 years with Stage 0-3 breast cancer.
- Are able to read and speak English.
- Are ambulatory.
- Are sedentary (i.e., do not meet recommendations for moderate-intensity PA [30 minutes/ day or more for at least 5 days/ week] or vigorous-intensity PA [20 minutes/day or more for at least 3 days/week].
- Are able to walk unassisted.
- Have access to a telephone.
Who cannot join
- Women with:
- More advanced disease (Stage 4).
- Medical or psychiatric problems (e.g., substance abuse, coronary artery disease, peripheral vascular disease, diabetes, and orthopedic problems) that may interfere with protocol adherence will not be included.
- Participants will be asked to provide consent for medical chart review to extract disease and treatment variables. Eligible participants will obtain medical clearance from their physicians.
Trial locations and contacts
1 site in 1 country.
United States1 site
Centers for Behavioral and Preventive Medicine, The Miriam Hospital, One Hoppin Street, Suite 314
Providence, Rhode Island, 02903
About this study
Physical activity programs, when offered in research settings, have been shown to improve quality of life and reduce fatigue among breast cancer survivors. The investigators are training Reach to Recovery volunteers at the American Cancer Society (New England Division) to provide a 12-week telephone-based physical activity program (RTR Plus) for breast cancer survivors. The comparison group of survivors will receive Reach to Recovery services (RTR). Physical activity, fatigue and other outcomes will be examined among 108 breast cancer survivors at the start of the program, at 12 weeks and 24 weeks. If the physical activity program is found to be effective, there is a potential for dissemination among the 13,000 Reach to Recovery volunteers across the U.S.
Read the detailed description
The current study, a randomized controlled trial, represents the next step in our efforts to extend the research on physical activity to the community setting; community volunteers will deliver the intervention, thereby making physical activity interventions much more accessible to survivors. In partnership with the National ACS office (Atlanta, GA) and the New England ACS Division, researchers at the Miriam Hospital will share their skills, experience and resources to examine the effects of training RTR volunteers to deliver brief physical activity counseling to breast cancer survivors. Fifteen to twenty RTR volunteers will be trained to offer a 12-week telephone-based PA program as a supplement to 12-week RTR services (RTR Plus) vs. delivering the standard 12-week RTR services (RTR) to 108 breast cancer survivors. Assessments of physical activity, fatigue and other outcomes will be completed at baseline, 12 weeks and 24 weeks. Data on side-effects of the intervention and costs of intervention delivery will be tracked. If the proposed randomized trial demonstrates positive effects, the results will be used to design and support a dissemination trial of the effects of physical activity promotion to enhance cancer recovery in a community setting.
- Conditions
- Breast Cancer
- Being tested
- Moving Forward Together 2
- Keywords
- Breast cancer, Exercise, Physical activity, Community volunteers, Peer mentors, Peer coaches, Social support
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moving Forward Together 2Behavioural
Also called MFT2
RTR volunteers from the ACS will be trained to offer a 12-week telephone-based PA program as a supplement to standard 12-week RTR services.
| Study group | Role | What they receive |
|---|---|---|
| Phone-based PA program (RTR Plus) | Experimental | The PA intervention consists of PA counseling, matched to participants' motivational readiness, plus educational materials. RTR volunteers or "coaches" will be asked to contact participants by telephone once a week for 12 weeks. The purpose of these calls is to build a supportive relationship with the participant, monitor PA participation, identify any health concerns, assist the participant to identify relevant barriers to PA and help her to problem solve to overcome such barriers. Receives: Behavioral: Moving Forward Together 2 |
| Standard RTR services (RTR) | Active comparator | RTR volunteers will contact the participants in this group by telephone once a week, providing support and information integral to RTR. The volunteers will also review the educational materials sent to all participants receiving RTR services. This will allow the volunteers to build a relationship with the participants over 12 weeks and ensure that these participants receive a minimal intervention, reducing the risk of attrition at the 12-week assessment. Receives: Behavioral: Moving Forward Together 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity - recorded via accelerometer and through interviewer-administered Seven Day Activity Recall (7 day PAR).
Measured: Baseline, 12 weeks, 24 weeks
Secondary outcomes (1)
Fatigue - assessed with FACT-F
Measured: Baseline, 12 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2009 (estimated)
- Study startJan 2010
- Primary completionJan 2013 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Principal investigator, Bernardine M. Pinto, The Miriam Hospital
- Investigators
- Bernardine M. Pinto, Ph.D., Principal investigator, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00948701
- Sponsor's protocol ID
- 206208
- Other IDs
- 1R01CA132854-01A1
- Acronym
- MFT2
- Status last verified
- Dec 2012
- First submitted
- 27 Jul 2009
- Last updated
- 4 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pinto BM, Dunsiger SI, DeScenza VR, Stein K. Mediators of physical activity outcomes in a peer-led intervention for breast cancer survivors. Psychooncology. 2023 Apr;32(4):619-627. doi: 10.1002/pon.6107. Epub 2023 Jan 27.
PubMed 36683179
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Volunteers Promoting Physical Activity Among Cancer Survivors
- ClinicalTrials.gov ID
- NCT00948701
- Acronym / sponsor ID
- MFT2 / 206208
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Exercise, Physical activity, Community volunteers, Peer mentors, Peer coaches, Social support
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- Jan 2010
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 29 Jul 2009 (estimated)
- 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.
Physical activity programs, when offered in research settings, have been shown to improve quality of life and reduce fatigue among breast cancer survivors. The investigators are training Reach to Recovery volunteers at the American Cancer Society (New England Division) to provide a 12-week telephone-based physical activity program (RTR Plus) for breast cancer survivors. The comparison group of survivors will receive Reach to Recovery services (RTR). Physical activity, fatigue and other outcomes will be examined among 108 breast cancer survivors at the start of the program, at 12 weeks and 24 weeks. If the physical activity program is found to be effective, there is a potential for dissemination among the 13,000 Reach to Recovery volunteers across the U.S.
Detailed description
The current study, a randomized controlled trial, represents the next step in our efforts to extend the research on physical activity to the community setting; community volunteers will deliver the intervention, thereby making physical activity interventions much more accessible to survivors. In partnership with the National ACS office (Atlanta, GA) and the New England ACS Division, researchers at the Miriam Hospital will share their skills, experience and resources to examine the effects of training RTR volunteers to deliver brief physical activity counseling to breast cancer survivors. Fifteen to twenty RTR volunteers will be trained to offer a 12-week telephone-based PA program as a supplement to 12-week RTR services (RTR Plus) vs. delivering the standard 12-week RTR services (RTR) to 108 breast cancer survivors. Assessments of physical activity, fatigue and other outcomes will be completed at baseline, 12 weeks and 24 weeks. Data on side-effects of the intervention and costs of intervention delivery will be tracked. If the proposed randomized trial demonstrates positive effects, the results will be used to design and support a dissemination trial of the effects of physical activity promotion to enhance cancer recovery in a community setting.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phone-based PA program (RTR Plus) | Experimental | Behavioral: Moving Forward Together 2The PA intervention consists of PA counseling, matched to participants' motivational readiness, plus educational materials. RTR volunteers or "coaches" will be asked to contact participants by telephone once a week for 12 weeks. The purpose of these calls is to build a supportive relationship with the participant, monitor PA participation, identify any health concerns, assist the participant to identify relevant barriers to PA and help her to problem solve to overcome such barriers. |
| Standard RTR services (RTR) | Active comparator | Behavioral: Moving Forward Together 2RTR volunteers will contact the participants in this group by telephone once a week, providing support and information integral to RTR. The volunteers will also review the educational materials sent to all participants receiving RTR services. This will allow the volunteers to build a relationship with the participants over 12 weeks and ensure that these participants receive a minimal intervention, reducing the risk of attrition at the 12-week assessment. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Women aged 21 years or over with Stage 0-3 breast cancer will be eligible if they:
Key exclusion criteria (4 listed)
- Women with:
- Participants will be asked to provide consent for medical chart review to extract disease and treatment variables. Eligible participants will obtain medical clearance from their physicians.
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 |
|---|---|---|
| Moving Forward Together 2Also: MFT2RTR volunteers from the ACS will be trained to offer a 12-week telephone-based PA program as a supplement to standard 12-week RTR services. | Behavioural | Phone-based PA program (RTR Plus), Standard RTR services (RTR) |
Primary outcome
Physical activity - recorded via accelerometer and through interviewer-administered Seven Day Activity Recall (7 day PAR).
Time frame: Baseline, 12 weeks, 24 weeks
1 secondary outcome
Fatigue - assessed with FACT-F
Time frame: Baseline, 12 weeks, 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2012.
- Derived from this study: PubMed 36683179Pinto BM, Dunsiger SI, DeScenza VR, Stein K. Mediators of physical activity outcomes in a peer-led intervention for breast cancer survivors. Psychooncology. 2023 Apr;32(4):619-627. doi: 10.1002/pon.6107. Epub 2023 Jan 27.
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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, Ph.D. principal investigator
The Miriam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moving Forward Together 2 in people with Breast Cancer, run by The Miriam Hospital 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 8 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 4 Dec 2012. 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?
Results are not available in the source record.
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?
Physical activity - recorded via accelerometer and through interviewer-administered Seven Day Activity Recall (7 day PAR). (time frame: Baseline, 12 weeks, 24 weeks). 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 NCT00948701, which also lists 1 linked publication.
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 4 Dec 2012.