Peers Promoting Exercise Adoption and Maintenance Among Cancer Survivors

June 6, 2024 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
161

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Physical Activity
Time Frame: 9 and 12 months
Through interviewer - administered Seven Day Activity Recall
9 and 12 months
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)
9 and 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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. Scale ranges from 0-148 with higher scores indicating higher quality of life.
Change at 9 and 12 months
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).
Score at 9 and 12 months
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.
Score at 9 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of South Carolina

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)
American Cancer Society, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 29, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 10, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 042015
  • 5R01CA183849-05 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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