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Trial record 1 of 1 for:    NCT02694640
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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
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
Bernardine Pinto, University of South Carolina

Tracking Information
First Submitted Date  ICMJE February 12, 2016
First Posted Date  ICMJE February 29, 2016
Last Update Posted Date November 4, 2020
Actual Study Start Date  ICMJE January 2016
Actual Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2019)
Physical Activity [ Time Frame: Change at 9 and 12 months ]
Through interviewer - administered Seven Day Activity Recall & wearing the Actigraph accelerometer (GT3X)
Original Primary Outcome Measures  ICMJE
 (submitted: February 23, 2016)
Physical Activity [ Time Frame: Change at 9 and 12 months ]
Through interviewer - administered Seven Day Activity Recall
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2018)
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2016)
  • Quality of life [ Time Frame: Change at 9 and 12 months ]
    Assessed via FACT-B
  • Fatigue [ Time Frame: Change at 9 and 12 months ]
    Assessed via FACT-F
  • Mood [ Time Frame: Change at 9 and 12 months ]
    Assessed via POMS
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Peers Promoting Exercise Adoption and Maintenance Among Cancer Survivors
Official Title  ICMJE Peers Promoting Exercise Adoption and Maintenance Among Cancer Survivors
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • 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.
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Reach Plus
  • 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.
    Intervention: Behavioral: Reach Plus Phone
  • 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.
    Intervention: Behavioral: Reach Plus Message
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 2, 2020)
161
Original Estimated Enrollment  ICMJE
 (submitted: February 23, 2016)
150
Actual Study Completion Date  ICMJE March 2020
Actual Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02694640
Other Study ID Numbers  ICMJE 042015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Bernardine Pinto, University of South Carolina
Study Sponsor  ICMJE University of South Carolina
Collaborators  ICMJE American Cancer Society, Inc.
Investigators  ICMJE
Principal Investigator: Bernardine M Pinto, PhD University of South Carolina - College of Nursing
PRS Account University of South Carolina
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP