- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02694640
Peers Promoting Exercise Adoption and Maintenance Among Cancer Survivors
November 2, 2020 updated by: Bernardine Pinto, University of South Carolina
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
161
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
South Carolina
-
Columbia, South Carolina, United States, 29208
- University of South Carolina, College of Nursing
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical Activity
Time Frame: Change at 9 and 12 months
|
Through interviewer - administered Seven Day Activity Recall & wearing the Actigraph accelerometer (GT3X)
|
Change at 9 and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Change at 9 and 12 months
|
Fatigue
Time Frame: Change at 9 and 12 months
|
Assessed via the Functional Assessment of Cancer Therapy Scale - Fatigue (FACT-F)
|
Change at 9 and 12 months
|
Mood
Time Frame: Change at 9 and 12 months
|
Assessed via the Profile of Mood States (POMS)
|
Change at 9 and 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Bernardine M Pinto, PhD, University of South Carolina - College of Nursing
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. 2022 Jan 7. doi: 10.1007/s11764-021-01162-z. Online ahead of print.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2016
Primary Completion (Actual)
March 1, 2020
Study Completion (Actual)
March 1, 2020
Study Registration Dates
First Submitted
February 12, 2016
First Submitted That Met QC Criteria
February 23, 2016
First Posted (Estimate)
February 29, 2016
Study Record Updates
Last Update Posted (Actual)
November 4, 2020
Last Update Submitted That Met QC Criteria
November 2, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 042015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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