Clinical trial NCT00948701: Community Volunteers Promoting Physical Activity Among Cancer Survivors
Official title: Community Volunteers Promoting Physical Activity Among Cancer Survivors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer
Exercise
Physical activity
Community volunteers
Peer mentors
Peer coaches
Social support
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2009-07-29
Enrollment: 108
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Physical activity - recorded via accelerometer and through interviewer-administered Seven Day Activity Recall (7 day PAR).
timeFrame: Baseline, 12 weeks, 24 weeks
Secondary outcomes:
measure: Fatigue - assessed with FACT-F
timeFrame: Baseline, 12 weeks, 24 weeks
Other outcomes:
Locations:
city: Providence
country: United States
facility: Centers for Behavioral and Preventive Medicine, The Miriam Hospital, One Hoppin Street, Suite 314
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital
name: Bernardine M. Pinto, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: