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Peers Promoting Exercise Adoption and Maintenance Among Cancer Survivors

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reach Plus
Reach Plus Phone
Reach Plus Message
Sponsored by
University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast cancer, Exercise, Physical activity, Community volunteers, Peer mentors, Peer coaches, Social support, Exercise maintenance

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • University of South Carolina, College of Nursing

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Reach Plus

Reach Plus Phone

Reach Plus Message

Arm Description

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, 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, 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.

Outcomes

Primary Outcome Measures

Physical Activity
Through interviewer - administered Seven Day Activity Recall & wearing the Actigraph accelerometer (GT3X)

Secondary Outcome Measures

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.
Fatigue
Assessed via the Functional Assessment of Cancer Therapy Scale - Fatigue (FACT-F)
Mood
Assessed via the Profile of Mood States (POMS)

Full Information

First Posted
February 12, 2016
Last Updated
November 2, 2020
Sponsor
University of South Carolina
Collaborators
American Cancer Society, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02694640
Brief Title
Peers Promoting Exercise Adoption and Maintenance Among Cancer Survivors
Official Title
Peers Promoting Exercise Adoption and Maintenance Among Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
March 2020 (Actual)
Study Completion Date
March 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Carolina
Collaborators
American Cancer Society, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast cancer, Exercise, Physical activity, Community volunteers, Peer mentors, Peer coaches, Social support, Exercise maintenance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
161 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reach Plus
Arm Type
Experimental
Arm Description
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.
Arm Title
Reach Plus Phone
Arm Type
Experimental
Arm Description
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.
Arm Title
Reach Plus Message
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Reach Plus
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Reach Plus Phone
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Reach Plus Message
Intervention Description
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.
Primary Outcome Measure Information:
Title
Physical Activity
Description
Through interviewer - administered Seven Day Activity Recall & wearing the Actigraph accelerometer (GT3X)
Time Frame
Change at 9 and 12 months
Secondary Outcome Measure Information:
Title
Breast Cancer Quality of life
Description
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.
Time Frame
Change at 9 and 12 months
Title
Fatigue
Description
Assessed via the Functional Assessment of Cancer Therapy Scale - Fatigue (FACT-F)
Time Frame
Change at 9 and 12 months
Title
Mood
Description
Assessed via the Profile of Mood States (POMS)
Time Frame
Change at 9 and 12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernardine M Pinto, PhD
Organizational Affiliation
University of South Carolina - College of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Carolina, College of Nursing
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29208
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34994945
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.
Results Reference
derived
PubMed Identifier
34436552
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.
Results Reference
derived

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Peers Promoting Exercise Adoption and Maintenance Among Cancer Survivors

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