Community Volunteers Promoting Physical Activity Among Cancer Survivors (MFT2)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
Bernardine M. Pinto, The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT00948701
First received: July 27, 2009
Last updated: December 3, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Breast Cancer
Behavioral: Moving Forward Together 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Community Volunteers Promoting Physical Activity Among Cancer Survivors

Resource links provided by NLM:


Further study details as provided by The Miriam Hospital:

Primary Outcome Measures:
  • Physical activity - recorded via accelerometer and through interviewer-administered Seven Day Activity Recall (7 day PAR). [ Time Frame: Baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fatigue - assessed with FACT-F [ Time Frame: Baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 108
Study Start Date: January 2010
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.
Other Name: MFT2
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
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.
Other Name: MFT2

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00948701

Locations
United States, Rhode Island
Centers for Behavioral and Preventive Medicine, The Miriam Hospital, One Hoppin Street, Suite 314
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
The Miriam Hospital
American Cancer Society, Inc.
Investigators
Principal Investigator: Bernardine M. Pinto, Ph.D. The Miriam Hospital
  More Information

No publications provided

Responsible Party: Bernardine M. Pinto, Professor, The Miriam Hospital
ClinicalTrials.gov Identifier: NCT00948701     History of Changes
Other Study ID Numbers: 206208, 1R01CA132854-01A1
Study First Received: July 27, 2009
Last Updated: December 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The Miriam Hospital:
Breast cancer
Exercise
Physical activity
Community volunteers
Peer mentors
Peer coaches
Social support

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 20, 2014