Peers Promoting Exercise Adoption and Maintenance Among Cancer Survivors
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ClinicalTrials.gov Identifier: NCT02694640 |
Recruitment Status :
Completed
First Posted : February 29, 2016
Last Update Posted : November 4, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer | Behavioral: Reach Plus Behavioral: Reach Plus Phone Behavioral: Reach Plus Message | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 161 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Peers Promoting Exercise Adoption and Maintenance Among Cancer Survivors |
Actual Study Start Date : | January 2016 |
Actual Primary Completion Date : | March 2020 |
Actual Study Completion Date : | March 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: 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.
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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. |
Experimental: 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.
|
Behavioral: 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. |
Experimental: 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.
|
Behavioral: 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. |
- Physical Activity [ Time Frame: Change at 9 and 12 months ]Through interviewer - administered Seven Day Activity Recall & wearing the Actigraph accelerometer (GT3X)
- Breast Cancer Quality of life [ Time Frame: Change at 9 and 12 months ]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.
- Fatigue [ Time Frame: Change at 9 and 12 months ]Assessed via the Functional Assessment of Cancer Therapy Scale - Fatigue (FACT-F)
- Mood [ Time Frame: Change at 9 and 12 months ]Assessed via the Profile of Mood States (POMS)

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Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02694640
United States, South Carolina | |
University of South Carolina, College of Nursing | |
Columbia, South Carolina, United States, 29208 |
Principal Investigator: | Bernardine M Pinto, PhD | University of South Carolina - College of Nursing |
Responsible Party: | Bernardine Pinto, Associate Dean, University of South Carolina |
ClinicalTrials.gov Identifier: | NCT02694640 |
Other Study ID Numbers: |
042015 |
First Posted: | February 29, 2016 Key Record Dates |
Last Update Posted: | November 4, 2020 |
Last Verified: | November 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Breast cancer Exercise Physical activity Community volunteers |
Peer mentors Peer coaches Social support Exercise maintenance |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |