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Universidad de Wake ForestEvaluating a Physical Activity Index for Assessment and Counseling for Breast and Colon Cancer Survivors
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el ensayo' para ver y discutir la información del ensayo en el idioma que haya seleccionado.
El estudio clínico NCT06340503 es un ensayo intervencionista para Cáncer de mama, Cáncer de colon. Su estado actual es: activo, no reclutando. El ensayo se inició el 6 de noviembre de 2024, con el objetivo de reclutar a 20 participantes. Dirigido por la Universidad de Wake Forest, se espera que finalice el 1 de junio de 2026. Los datos se actualizaron por última vez en ClinicalTrials.gov el 2 de julio de 2025.
Resumen
The purpose of this research study is to determine whether using the physical activity index screener, exercise coaching, and self-monitoring will increase physical activity and reduce time spent sitting or being inactive in patients who had breast or colon cancer.
Descripción detallada
To assess the feasibility (participation rate, adherence, and retention) of the Physical Activity Index (PAI) intervention in breast and colon cancer survivors supported by exercise coaching and self-monitoring tools.
Título oficial
Evaluating a Physical Activity Index for Assessment and Counseling for Breast and Colon Cancer Survivors in Clinical Practice
Condiciones médicas
Cáncer de mamaCáncer de colonOtros ID del ensayo
- IRB00111331
- WFBCCC 01123 (Otro identificador) (Atrium Health Wake Forest Baptist Comprehensive Cancer Center)
- P30CA012197 (Subvención/contrato NIH (EE. UU.))
Número del NCT
Inicio del ensayo (real)
2024-11-06
Última actualización
2025-07-02
Fecha de finalización (estimada)
2026-06
Inscripción (prevista)
20
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Activo, no reclutando
Palabras clave
Physical activity
Exercise coaching
Exercise coaching
Objetivo principal
Cuidados de apoyo
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Ninguno (Etiqueta abierta)
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalExercise Group Participants randomized into the exercise group will receive a pre-exercise screening call about two weeks after enrolling into the study and complete the six (6) study visits and pre-determined test and procedures for the patient intervention arm. | Research-grade Accelerometer Participants will be instructed to wear device for 7 days prior to each visit and to bring the device to each visit. Study staff will extract data from the device within 14 days after each appointment and return the device to patients by mail. National Comprehensive Cancer Network (NCCN) Education Materials The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) are comprised of recommendations for the prevention, diagnosis, and management of malignancies across the continuum of care. Garmin Vivofit Activity Tracker This device can automatically capture and classify different physical activities such as walking, running, biking, swimming and using an elliptical. Exercise Consultation Calls The intervention group will receive five monthly exercise consultation calls with an exercise coach in between clinical visits and be provided with an exercise log for their personal use Entrevista The interviews will be conducted by a trained Q-PRO interviewer and audio recorded. Interviews are expected to last approximately 30 minutes. Discussion will include acceptability of the PAI intervention, related tools, and clinical experiences and will help shape/inform refinements need for a larger efficacy trial Physical Activity Index Assessment (Intervention Arm) Assessment will capture frequency and time spent in strenuous, moderate, and mild PA over the past 7 days. Survivors also report hours of TV or similar sedentary screen time per week as a measure of sedentary behavior. Completed at months 1, 3, 6, 9 and 12 while on study Health Surveys Various health surveys will be completed to assess participant health and physical activities. |
Comparador activoDelayed Exercise Group Participants randomized to the delayed exercise group, will have vitals collected and complete surveys at the first (baseline), 3-month, and 6-month visits pre-determined test and procedures for the waitlist control arm. The pre-exercise consultation will begin after the 6-month visit. | Research-grade Accelerometer Participants will be instructed to wear device for 7 days prior to each visit and to bring the device to each visit. Study staff will extract data from the device within 14 days after each appointment and return the device to patients by mail. National Comprehensive Cancer Network (NCCN) Education Materials The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) are comprised of recommendations for the prevention, diagnosis, and management of malignancies across the continuum of care. Garmin Vivofit Activity Tracker This device can automatically capture and classify different physical activities such as walking, running, biking, swimming and using an elliptical. Entrevista The interviews will be conducted by a trained Q-PRO interviewer and audio recorded. Interviews are expected to last approximately 30 minutes. Discussion will include acceptability of the PAI intervention, related tools, and clinical experiences and will help shape/inform refinements need for a larger efficacy trial Physical Activity Index Assessment (Control Arm) Assessment will capture frequency and time spent in strenuous, moderate, and mild PA over the past 7 days. Survivors also report hours of TV or similar sedentary screen time per week as a measure of sedentary behavior. Completed at months 6, 9 and 12 while on study. Health Surveys Various health surveys will be completed to assess participant health and physical activities. |
Resultado primario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Number of Eligible Participants - Participation Rate | Participation will be measured by the number of eligible participants who agree to participate. Investigators will calculate 95% confidence interval for each of the feasibility measures to determine the range of estimates that are consistent with the data. | 17 months |
Percentage of Participants to Complete Exercise Sessions - Adherence | Adherence will be measured by the percent of participants who complete at least 3 out 5 exercise sessions. Investigators will calculate 95% confidence interval for each of the feasibility measures to determine the range of estimates that are consistent with the data. | 17 months |
Number of Participants Who Complete Study Questionnaires - Retention | Retention will be defined as the number of participants who complete study questionnaires at baseline and one follow-up timepoint. Investigators will calculate 95% confidence interval for each of the feasibility measures to determine the range of estimates that are consistent with the data. | At baseline and up to 17 months |
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
50 Years
Criterios de sexo
Todos
- Survivors of breast or colon cancer (stages 0-III) diagnosed within the last three years prior to enrollment.
- Completed primary treatment (surgery, chemotherapy, and/or radiation) at least 3 months prior to enrollment.
- At least 50 years of age or older.
- Access to internet or cellular plan for video calls.
- Being willing and able to comply with the approved protocol and able to sign an IRB-approved informed consent document directly, remotely or via electronic consent.
- Able to read and speak English
- Participants with metastatic disease.
- Participants with recurrence or diagnosis of a different cancer.
- Participants receiving treatment other than maintenance therapy for their primary cancer (breast or colon).
- Participants has prior conditions that contraindicate exercise as determined by treating physician.
- Participants has gross cognitive impairment as determined by treating physician.
Universidad de Wake Forest323 ensayos clínicos activos para explorarInstituto Nacional del Corazón, los Pulmones y la Sangre, Estados Unidos3028 ensayos clínicos activos para explorarNo hay datos de contacto.
1 Sitios del ensayo en 1 países
North Carolina
Atrium Health Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem, North Carolina, 27157, United States