Breast CancerNCT02694640
Peers Promoting Exercise Adoption and Maintenance Among Cancer Survivors
A study testing Reach Plus, Reach Plus Phone and Reach Plus Message in people with Breast Cancer, run by University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Reach Plus, Reach Plus Phone and Reach Plus Message
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina, College of Nursing
Columbia, South Carolina, 29208
About this study
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Reach Plus, Reach Plus Phone, Reach Plus Message
- Keywords
- Breast cancer, Exercise, Physical activity, Community volunteers, Peer mentors, Peer coaches, Social support, Exercise maintenance
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reach PlusBehavioural
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 PhoneBehavioural
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 MessageBehavioural
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 group | Role | What they receive |
|---|---|---|
| Reach Plus | Experimental | 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. Receives: Behavioral: Reach Plus |
| Reach Plus Phone | Experimental | 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. Receives: Behavioral: Reach Plus Phone |
| Reach Plus Message | Experimental | 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. Receives: Behavioral: Reach Plus Message |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity
Through interviewer - administered Seven Day Activity Recall
Measured: 9 and 12 months
Min/Week Objectively Measured Moderate-to-vigorous Physical Activity
Minutes per week of at least moderate intensity activity as measured by accelerometer (GT3X)
Measured: 9 and 12 months
Secondary outcomes (3)
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. Scale ranges from 0-148 with higher scores indicating higher quality of life.
Measured: Change at 9 and 12 months
Fatigue
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).
Measured: Score at 9 and 12 months
Mood
Assessed via the Profile of Mood States (POMS). Higher scores indicated a greater mood disturbance. Scale ranges from 0-28.
Measured: Score at 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionMar 2020
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), American Cancer Society, Inc.
- Responsible party
- Principal investigator, Bernardine Pinto, University of South Carolina
- Investigators
- Bernardine M Pinto, PhD, Principal investigator, University of South Carolina - College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02694640
- Sponsor's protocol ID
- 042015
- Other IDs
- 5R01CA183849-05
- Status last verified
- Jun 2024
- First submitted
- 12 Feb 2016
- Last updated
- 10 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 34436552Pinto BM, Dunsiger SI, Kindred M, Mitchell S, DeScenza V. Effects of a peer-led physical activity program on psychosocial outcomes among breast cancer survivors. Psychooncology. 2024 Jan;33(1):e6292. doi: 10.1002/pon.6292.
PubMed 38282225Pinto BM, Dunsiger SI, Kindred MM, Mitchell S. Mediators of physical activity maintenance during a 12-month randomized controlled trial among breast Cancer survivors. J Behav Med. 2023 Oct;46(5):745-756. doi: 10.1007/s10865-023-00402-0. Epub 2023 Mar 9.
PubMed 36892780Pinto 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.
PubMed 34994945
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peers Promoting Exercise Adoption and Maintenance Among Cancer Survivors
- ClinicalTrials.gov ID
- NCT02694640
- Acronym / sponsor ID
- 042015
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Exercise, Physical activity, Community volunteers, Peer mentors, Peer coaches, Social support, Exercise maintenance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), American Cancer Society, Inc.
- Study start
- Jan 2016 (actual)
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 29 Feb 2016 (estimated)
- Results
- Posted 10 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Reach Plus | Experimental | Behavioral: Reach PlusIn 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 | Experimental | Behavioral: Reach Plus PhoneIn 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 | Experimental | Behavioral: Reach Plus MessageIn 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reach PlusIn 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. | Behavioural | Reach Plus |
| Reach Plus PhoneIn 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. | Behavioural | Reach Plus Phone |
| Reach Plus MessageIn 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. | Behavioural | Reach Plus Message |
Primary outcome
Physical Activity
Time frame: 9 and 12 months
Through interviewer - administered Seven Day Activity Recall
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)
3 secondary outcomes
Breast Cancer Quality of Life
Time frame: Change at 9 and 12 months
Fatigue
Time frame: Score at 9 and 12 months
Mood
Time frame: Score at 9 and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 34436552Pinto 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.
- Derived from this study: PubMed 38282225Pinto BM, Dunsiger SI, Kindred M, Mitchell S, DeScenza V. Effects of a peer-led physical activity program on psychosocial outcomes among breast cancer survivors. Psychooncology. 2024 Jan;33(1):e6292. doi: 10.1002/pon.6292.
- Derived from this study: PubMed 36892780Pinto BM, Dunsiger SI, Kindred MM, Mitchell S. Mediators of physical activity maintenance during a 12-month randomized controlled trial among breast Cancer survivors. J Behav Med. 2023 Oct;46(5):745-756. doi: 10.1007/s10865-023-00402-0. Epub 2023 Mar 9.
- Derived from this study: PubMed 34994945Pinto 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernardine M Pinto, PhD principal investigator
University of South Carolina - College of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reach Plus, Reach Plus Phone and Reach Plus Message in people with Breast Cancer, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity (time frame: 9 and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02694640, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2024.