Community Volunteers Promoting Physical Activity Among Cancer Survivors

NCT00948701 | Unknown DMC

• 2 other identifiers: 2062081R01CA132854-01A1
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  Baseline, 12 weeks, 24 weeks

Secondary Outcomes (1)

• Fatigue - assessed with FACT-F

  Baseline, 12 weeks, 24 weeks

Study Arms (2)

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.

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.

Behavioral: Moving Forward Together 2

Interventions

Moving Forward Together 2 BEHAVIORAL

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

Phone-based PA program (RTR Plus); Standard RTR services (RTR)

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Miriam Hospital: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

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

Providence, Rhode Island, 02903, United States

Location

Related Publications (1)

• 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.

  PMID: 36683179 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Study Officials

• Bernardine M. Pinto, Ph.D.

  The Miriam Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 27, 2009
• First Posted: July 29, 2009
• Study Start: January 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: December 4, 2012

Record last verified: 2012-12

Locations

US (1)