Estudio de asesoramiento sobre cáncer y educación remota para el autoempoderamiento (CARES)
This Pilot Study will evaluate a 12-week pilot program that offers digital health coaching for individuals with pancreatic cancer and their caregivers.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase temprana 1
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Florida
-
Tampa, Florida, Estados Unidos, 33612
- Moffitt Cancer Center
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- 18 years of age or older.
- Participant must have a pancreatic cancer diagnosis or be a caregiver such as a friend or spouse.
- Participant must be planning to receive treatment and/or care management at Moffitt Cancer Center.
- Participant must be able to speak and read English.
- Participant must be able to provide informed consent.
Exclusion Criteria:
- Documented or observable psychiatric or neurological disorder that would interfere with study participation such as severe dementia
- Any participant that does not meet all inclusion criteria will be excluded.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: Digital Health Coaching for Pancreatic Cancer Patients
Initial in-person and/or virtual supportive care, social work, and dietitian consultation within 4 weeks of diagnosis and/or 3 weeks of study enrollment. |
Enrolled participants will set up an account through a secure and encrypted web portal managed by Osara Health. Coaches will follow-up with their designated patients and/or caregivers to schedule individual coaching sessions via phone, text, or email depending on the participant's communication preference. Participants will have an initial coaching consultation by phone to go over the purpose and structure of coaching sessions. Participants will then have an additional 3-4 coaching sessions (depending on time availability and need) to discuss symptom management, nutrition and exercise, sleep, and mindfulness. Participants will receive content for each of the modules via email. |
|
Otro: Digital Health Coaching for Caregivers
Initial in-person and/or virtual supportive care, social work, and dietitian consultation within 4 weeks of diagnosis and/or 3 weeks of study enrollment. |
Enrolled participants will set up an account through a secure and encrypted web portal managed by Osara Health. Coaches will follow-up with their designated patients and/or caregivers to schedule individual coaching sessions via phone, text, or email depending on the participant's communication preference. Participants will have an initial coaching consultation by phone to go over the purpose and structure of coaching sessions. Participants will then have an additional 3-4 coaching sessions (depending on time availability and need) to discuss symptom management, nutrition and exercise, sleep, and mindfulness. Participants will receive content for each of the modules via email. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Recruitment Rate
Periodo de tiempo: Up to 12 Months
|
Measured by ≥ 50% of eligible participants recruited. |
Up to 12 Months
|
|
Participant Acceptance of the Digital Health Coaching Program
Periodo de tiempo: Up to 12 Weeks
|
Measured by ≥ 70% of participant rating of the intervention as satisfactory. 4 item scale (score range 0-20) will be utilized. |
Up to 12 Weeks
|
|
Participant Ease of Usability of the Digital Health Coaching Program
Periodo de tiempo: Up to 12 Weeks
|
Measured by ≥ 70% of participant rating the mobile application as easy-to-use for scheduling coaching visits. 4 item scale (score range 0-20) will be utilized. |
Up to 12 Weeks
|
|
Feasibility of Utilizing the Digital Health Coaching Program
Periodo de tiempo: Up to 12 Weeks
|
Measured by ≥ 70% of participant rating of being likely to utilize the intervention. 4 item scale (score range 0-20) will be utilized. |
Up to 12 Weeks
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Pamela Hodul, MD, Moffitt Cancer Center
- Investigador principal: Amir Alishahi Tabriz, MD, PhD, Moffitt Cancer Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- MCC-23077
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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