Peers Promoting Exercise Adoption and Maintenance Among Cancer Survivors

Breast Cancer Clinical Trial

Official title:

Peers Promoting Exercise Adoption and Maintenance Among Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02694640
• Other study ID #: 042015
• Secondary ID: 5R01CA183849-05
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: March 2020

Study information

• Verified date: June 2024
• Source: University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Reach Plus
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 Phone
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 Message
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.

Locations

Country	Name	City	State
United States	University of South Carolina, College of Nursing	Columbia	South Carolina

Sponsors (3)

Lead Sponsor	Collaborator
University of South Carolina	American Cancer Society, Inc., National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical Activity	Through interviewer - administered Seven Day Activity Recall	9 and 12 months
Primary	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	Breast Cancer Quality of Life	Assessed via the Functional Assessment of Cancer Therapy Scale - Breast (FACT-B) Sub-scales scored: Physical well-being, social/family well-being, emotional well-being, functional well-being and other breast cancer related statements. Scale ranges from 0-148 with higher scores indicating higher quality of life.	Change at 9 and 12 months
Secondary	Fatigue	Assessed via the Functional Assessment of Cancer Therapy Scale - Fatigue (FACT-F). This scale ranges from 0-52. Higher values indicate better functioning (or lower fatigue).	Score at 9 and 12 months
Secondary	Mood	Assessed via the Profile of Mood States (POMS). Higher scores indicated a greater mood disturbance. Scale ranges from 0-28.	Score at 9 and 12 months