CClinicalTrials.gg
Status unknownNCT00948701MFT2Updated Dec 4, 2012

Community Volunteers Promoting Physical Activity Among Cancer Survivors

An interventional study of Moving Forward Together 2 in Breast Cancer, sponsored by The Miriam Hospital. Status unknown at 1 site in United States. Open to female participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-12-04.

Sponsored by The Miriam Hospital · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Dec 2012), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
108
Allocation
Randomized
Ages
21 Years and older
Sex
Female
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Study 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 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.

02

Conditions studied

  • Breast Cancer

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Keywords

  • Breast cancer
  • Exercise
  • Physical activity
  • Community volunteers
  • Peer mentors
  • Peer coaches
  • Social support
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 108 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

The Miriam Hospital is the lead sponsor of 178 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
108 participants (estimated)

Study arms

  • Experimental
    Phone-based PA program (RTR Plus)

    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.

    Behavioral: Moving Forward Together 2

  • Active comparator
    Standard RTR services (RTR)

    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.

    Behavioral: Moving Forward Together 2

Interventions

  • BehavioralMoving Forward Together 2

    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.

    Also known as: MFT2

06

What researchers measure

Primary outcomes

  1. Physical activity - recorded via accelerometer and through interviewer-administered Seven Day Activity Recall (7 day PAR).

    Time frame: Baseline, 12 weeks, 24 weeks

Secondary outcomes

  1. Fatigue - assessed with FACT-F

    Time frame: Baseline, 12 weeks, 24 weeks

07

Study locations

1 site
  • Centers for Behavioral and Preventive Medicine, The Miriam Hospital, One Hoppin Street, Suite 314
    Providence, Rhode Island 02903, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00948701
Lead sponsor
The Miriam Hospital
Collaborators
American Cancer Society, Inc.
Responsible party
Bernardine M. Pinto (Professor, The Miriam Hospital) — Principal investigator
First posted
Jul 29, 2009
Start date
Jan 2010
Primary completion
Jan 2013 (estimated)
Completion
Jan 2013 (estimated)
Last update
Dec 4, 2012

Study contacts

Bernardine M. Pinto, Ph.D.
principal investigator · The Miriam Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.

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