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- Ensayo clínico NCT02694640
Peers Promoting Exercise Adoption and Maintenance Among Cancer Survivors
2 de noviembre de 2020 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
161
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
South Carolina
-
Columbia, South Carolina, Estados Unidos, 29208
- University of South Carolina, College of Nursing
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
21 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Femenino
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
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.
|
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.
|
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.
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Physical Activity
Periodo de tiempo: Change at 9 and 12 months
|
Through interviewer - administered Seven Day Activity Recall & wearing the Actigraph accelerometer (GT3X)
|
Change at 9 and 12 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Breast Cancer Quality of life
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Change at 9 and 12 months
|
Assessed via the Profile of Mood States (POMS)
|
Change at 9 and 12 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Bernardine M Pinto, PhD, University of South Carolina - College of Nursing
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de enero de 2016
Finalización primaria (Actual)
1 de marzo de 2020
Finalización del estudio (Actual)
1 de marzo de 2020
Fechas de registro del estudio
Enviado por primera vez
12 de febrero de 2016
Primero enviado que cumplió con los criterios de control de calidad
23 de febrero de 2016
Publicado por primera vez (Estimar)
29 de febrero de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de noviembre de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
2 de noviembre de 2020
Última verificación
1 de noviembre de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 042015
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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