Clinical trial NCT02694640: Peers Promoting Exercise Adoption and Maintenance Among Cancer Survivors
Official title: Peers Promoting Exercise Adoption and Maintenance Among Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer
Exercise
Physical activity
Community volunteers
Peer mentors
Peer coaches
Social support
Exercise maintenance
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: American Cancer Society, Inc.
First posted: 2016-02-29
Enrollment: 161
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Exercise adoption enhances well-being and recovery from breast cancer. Researchers trained American Cancer Society volunteers to provide exercise counseling to breast cancer survivors and the survivors increased their exercise in the short-term. This RCT examines the effects of three maintenance conditions on survivors' exercise participation at longer follow-ups. The cost-effectiveness of the three groups will be examined to guide implementation of this peer mentoring approach in community-based organizations.

Detailed description: The current study, a randomized controlled trial (RCT), represents the next step of the efforts to 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 American Cancer Society office (Atlanta, GA) and Reach To Recovery (RTR) programs in North Carolina, South Carolina, and Georgia, researchers at the University of South Carolina's College of Nursing will share skills, experience and resources to examine the effects of RTR coaches offering a theoretically-based 3-month exercise program among 150 breast cancer survivors to increase moderate-to-vigorous physical activity (MVPA) followed by self-monitoring (i.e. exercise logs) and feedback reports in Months 4-9 (Reach Plus), monthly phone calls from RTR coaches, self monitoring and feedback reports in Months 4-9 (Reach Plus Message) or weekly email/text messages, self-monitoring and feedback reports in Months 4-9 (Reach Plus Message). In this three group study, researchers will assess survivors' exercise, fatigue, mood, quality of life, and self-reported physical functioning at baseline, 3, 9 and 12 months. The costs of the methods vary and data on costs will be collected to guide the selection of maintenance strategies for dissemination. If the results are promising, researchers will proceed with a dissemination trial wherein the large network of RTR volunteers can expand the scope of their services to benefit breast cancer survivors.

Eligibility criteria: Inclusion Criteria:

Women aged 21 years or over will be eligible if they:

* 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
timeFrame: 9 and 12 months
measure: Min/Week Objectively Measured Moderate-to-vigorous Physical Activity
timeFrame: 9 and 12 months
Secondary outcomes:
measure: Breast Cancer Quality of Life
timeFrame: Change at 9 and 12 months
measure: Fatigue
timeFrame: Score at 9 and 12 months
measure: Mood
timeFrame: Score at 9 and 12 months
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of South Carolina, College of Nursing
state: South Carolina
Study officials:
affiliation: University of South Carolina - College of Nursing
name: Bernardine M Pinto, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pinto BM, Dunsiger SI, Kindred MM, Mitchell S. Physical Activity Adoption and Maintenance Among Breast Cancer Survivors: A Randomized Trial of Peer Mentoring. Ann Behav Med. 2022 Aug 2;56(8):842-855. doi: 10.1093/abm/kaab078.
citation: Pinto BM, Dunsiger SI, Kindred MM, Mitchell S. Peer mentoring for physical activity adoption and maintenance among breast cancer survivors: moderators of physical activity outcomes. J Cancer Surviv. 2023 Aug;17(4):1211-1220. doi: 10.1007/s11764-021-01162-z. Epub 2022 Jan 7.