- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02694640
Peers Promoting Exercise Adoption and Maintenance Among Cancer Survivors
2. november 2020 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
161
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
South Carolina
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Columbia, South Carolina, Forenede Stater, 29208
- University of South Carolina, College of Nursing
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
21 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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.
|
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.
|
Eksperimentel: 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.
|
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.
|
Eksperimentel: 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.
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Physical Activity
Tidsramme: Change at 9 and 12 months
|
Through interviewer - administered Seven Day Activity Recall & wearing the Actigraph accelerometer (GT3X)
|
Change at 9 and 12 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Breast Cancer Quality of life
Tidsramme: 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.
|
Change at 9 and 12 months
|
Fatigue
Tidsramme: Change at 9 and 12 months
|
Assessed via the Functional Assessment of Cancer Therapy Scale - Fatigue (FACT-F)
|
Change at 9 and 12 months
|
Mood
Tidsramme: Change at 9 and 12 months
|
Assessed via the Profile of Mood States (POMS)
|
Change at 9 and 12 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Bernardine M Pinto, PhD, University of South Carolina - College of Nursing
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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. 2022 Jan 7. doi: 10.1007/s11764-021-01162-z. Online ahead of print.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. januar 2016
Primær færdiggørelse (Faktiske)
1. marts 2020
Studieafslutning (Faktiske)
1. marts 2020
Datoer for studieregistrering
Først indsendt
12. februar 2016
Først indsendt, der opfyldte QC-kriterier
23. februar 2016
Først opslået (Skøn)
29. februar 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. november 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. november 2020
Sidst verificeret
1. november 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 042015
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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