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Completed

NCT Number: NCT02694640

Peers Promoting Exercise Adoption and Maintenance Among Cancer Survivors

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.

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Key information

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of South Carolina, College of Nursing

Columbia, South Carolina, 29208, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Reach Plus

Behavioral

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

Behavioral

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

Behavioral

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 outcomes

  1. Physical Activity

    Time frame: 9 and 12 months

    Through interviewer - administered Seven Day Activity Recall

  2. Min/Week Objectively Measured Moderate-to-vigorous Physical Activity

    Time frame: 9 and 12 months

    Minutes per week of at least moderate intensity activity as measured by accelerometer (GT3X)

Secondary outcomes

  1. 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. Scale ranges from 0-148 with higher scores indicating higher quality of life.

  2. Fatigue

    Time frame: Score at 9 and 12 months

    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).

  3. Mood

    Time frame: Score at 9 and 12 months

    Assessed via the Profile of Mood States (POMS). Higher scores indicated a greater mood disturbance. Scale ranges from 0-28.

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Collaborators

  • American Cancer Society, Inc.
  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Feb 29, 2016
Registry last updated
Jun 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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