Peers Promoting Exercise Adoption and Maintenance Among Cancer Survivors

NCT02694640 | Completed Results

• 2 other identifiers: 0420155R01CA183849-05
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Physical Activity

  Through interviewer - administered Seven Day Activity Recall

  9 and 12 months

• Min/Week Objectively Measured Moderate-to-vigorous Physical Activity

  Minutes per week of at least moderate intensity activity as measured by accelerometer (GT3X)

  9 and 12 months

Secondary Outcomes (3)

• Breast Cancer Quality of Life

  Change at 9 and 12 months

• Fatigue

  Score at 9 and 12 months

• Mood

  Score at 9 and 12 months

Study Arms (3)

Reach Plus

EXPERIMENTAL

In Months 1-3, participants in this group will receive the previously tested telephone counseling for exercise. RTR volunteers or "coaches" will be asked to contact participants by telephone weekly over 3 months (12 calls). In months 4-9, participants will no longer receive calls from RTR coaches and will be encouraged to use the heart rate monitors and pedometers during exercise. Participants will continue to complete their exercise logs and receive feedback reports from study staff.

Behavioral: Reach Plus

Reach Plus Phone

EXPERIMENTAL

In Months 1-3, participants in this group will receive the previously tested telephone counseling for exercise. RTR volunteers or "coaches" will be asked to contact participants by telephone weekly over 3 months (12 calls). In months 4-9, these participants will have the opportunity to continue to receive support calls from their coach. Participants will also continue to complete their exercise logs and receive feedback reports from study staff.

Behavioral: Reach Plus Phone

Reach Plus Message

EXPERIMENTAL

In Months 1-3, participants in this group will receive the previously tested telephone counseling for exercise. RTR volunteers or "coaches" will be asked to contact participants by telephone weekly over 3 months (12 calls). In months 4-9, participants will receive messages by email or text to motivate, prompt and reinforce continued exercise. Participants will also continue to complete their exercise logs and receive feedback reports from study staff.

Behavioral: Reach Plus Message

Interventions

Reach Plus BEHAVIORAL

In Months 1-3, participants in this group will receive the previously tested telephone counseling for exercise. RTR volunteers or "coaches" will be asked to contact participants by telephone weekly over 3 months (12 calls). In months 4-9, participants will no longer receive calls from RTR coaches and will be encouraged to use the heart rate monitors and pedometers during exercise. Participants will continue to complete their exercise logs and receive feedback reports from study staff.

Reach Plus

Reach Plus Phone BEHAVIORAL

In Months 1-3, participants in this group will receive the previously tested telephone counseling for exercise. RTR volunteers or "coaches" will be asked to contact participants by telephone weekly over 3 months (12 calls). In months 4-9, these participants will have the opportunity to continue to receive support calls from their coach. Participants will also continue to complete their exercise logs and receive feedback reports from study staff.

Reach Plus Phone

Reach Plus Message BEHAVIORAL

In Months 1-3, participants in this group will receive the previously tested telephone counseling for exercise. RTR volunteers or "coaches" will be asked to contact participants by telephone weekly over 3 months (12 calls). In months 4-9, participants will receive messages by email or text to motivate, prompt and reinforce continued exercise. Participants will also continue to complete their exercise logs and receive feedback reports from study staff.

Reach Plus Message

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 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.

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

• University of South Carolina: lead
• National Cancer Institute (NCI): collaborator
• American Cancer Society, Inc.: collaborator

Study Sites (1)

University of South Carolina, College of Nursing

Columbia, South Carolina, 29208, United States

Location

Related Publications (3)

• 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.

  PMID: 34436552 RESULT

• Pinto BM, Dunsiger SI, Kindred MM, Mitchell S. Mediators of physical activity maintenance during a 12-month randomized controlled trial among breast Cancer survivors. J Behav Med. 2023 Oct;46(5):745-756. doi: 10.1007/s10865-023-00402-0. Epub 2023 Mar 9.

  PMID: 36892780 DERIVED

• 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.

  PMID: 34994945 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

Limitations and Caveats

Limitations include limited generalizability of the findings. Further, retention rates differed by treatment condition.

Results Point of Contact

• Title: Dr. Bernardine Pinto
• Organization: University of South Carolina

pintob@mailbox.sc.edu

8037779272

Study Officials

• Bernardine M Pinto, PhD

  University of South Carolina - College of Nursing

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: February 12, 2016
• First Posted: February 29, 2016
• Study Start: January 1, 2016
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: June 10, 2024
• Results First Posted: June 10, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)