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Community Volunteers Promoting Physical Activity Among Cancer Survivors (MFT2)

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Moving Forward Together 2
Sponsored by
The Miriam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Breast cancer, Exercise, Physical activity, Community volunteers, Peer mentors, Peer coaches, Social support

Eligibility Criteria

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

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.

Sites / Locations

  • Centers for Behavioral and Preventive Medicine, The Miriam Hospital, One Hoppin Street, Suite 314

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Phone-based PA program (RTR Plus)

Standard RTR services (RTR)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Fatigue - assessed with FACT-F

Full Information

First Posted
July 27, 2009
Last Updated
December 3, 2012
Sponsor
The Miriam Hospital
Collaborators
American Cancer Society, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00948701
Brief Title
Community Volunteers Promoting Physical Activity Among Cancer Survivors
Acronym
MFT2
Official Title
Community Volunteers Promoting Physical Activity Among Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2013 (Anticipated)
Study Completion Date
January 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Miriam Hospital
Collaborators
American Cancer Society, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast cancer, Exercise, Physical activity, Community volunteers, Peer mentors, Peer coaches, Social support

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phone-based PA program (RTR Plus)
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard RTR services (RTR)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Moving Forward Together 2
Other Intervention Name(s)
MFT2
Intervention Description
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.
Primary Outcome Measure Information:
Title
Physical activity - recorded via accelerometer and through interviewer-administered Seven Day Activity Recall (7 day PAR).
Time Frame
Baseline, 12 weeks, 24 weeks
Secondary Outcome Measure Information:
Title
Fatigue - assessed with FACT-F
Time Frame
Baseline, 12 weeks, 24 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernardine M. Pinto, Ph.D.
Organizational Affiliation
The Miriam Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centers for Behavioral and Preventive Medicine, The Miriam Hospital, One Hoppin Street, Suite 314
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

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Community Volunteers Promoting Physical Activity Among Cancer Survivors

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