- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02412124
Peer-to-Peer Support Program in Improving Quality of Life Outcomes in Patients With Gynecologic Cancer and Their Caregivers
Quality of Life Outcomes From a Peer-to-Peer Support Program for Women With Gynecologic Cancer
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
PRIMARY OBJECTIVES:
I. To test the feasibility and acceptability of a Woman-to-Woman (W2W) program for patients with gynecologic cancer at City of Hope (COH). Address the following descriptive research questions: were patients, mentors, and patients' family caregivers satisfied with the timing, format, and content of the program? Did the program benefit patients, mentors, and patients' family caregivers?
OUTLINE:
Patients participate in the W2W program for which they are matched with a trained mentor and followed throughout treatment by phone, email, and/or in person.
After completion of study, patients are followed up at 6 and 12 months.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
California
-
Duarte, California, Estados Unidos, 91010
- City of Hope Medical Center
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- PATIENT PARTICIPANTS
- Patients with newly diagnosed or recurrent gynecologic cancer (ovarian, uterine, cervical, vaginal, vulvar) actively undergoing treatment (chemotherapy, surgery, or radiation therapy) at COH (including Duarte and South Pasadena campuses)
- English-speaking patients
- PEER MENTORS
- Peer mentors will be past gynecologic cancer patients not currently undergoing treatment for their cancer, and considered without evidence of disease
- Over age 18
- PEER MENTORS: English-speaking patients
- This study is open to patients of all races and ethnicities
Exclusion Criteria:
- PEER MENTORS:
- Major psychiatric disease
- Currently undergoing treatment for active gynecologic cancer
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Supportive care (W2W program)
Patients participate in the W2W program for which they are matched with a trained mentor and followed throughout treatment by phone, email, and/or in person.
|
Complete W2W mentoring program
Otros nombres:
Complete the FACT-G
Otros nombres:
Complete the W2W Patient Survey
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in quality of life benefits for patients, as assessed by the FACT-G
Periodo de tiempo: Baseline to up to 12 months
|
Changes from baseline will be tested using paired t-tests.
Data will be summarized using descriptive statistics, including means for normally distributed continuous data, medians for non-normally distributed continuous data or proportions for categorical data.
Established instruments will be scored according to standard instructions, and appropriate descriptive statistics computed.
Written comments from all open ended questions analyzed using content analysis methods.
|
Baseline to up to 12 months
|
Satisfaction of patients with the timing, content, and format of the program, as assessed by the W2W Patient Survey
Periodo de tiempo: Up to 12 months
|
Changes from baseline will be tested using paired t-tests.
Descriptive statistics on participants' satisfaction with the timing, content, and format of the intervention will be presented through summary statistics of data from the satisfaction tools.
Data will be summarized using descriptive statistics, including means for normally distributed continuous data, medians for non-normally distributed continuous data or proportions for categorical data.
|
Up to 12 months
|
Satisfaction of mentors with the timing, content, and format of the program, as assessed by the W2W Volunteer/Mentor Survey
Periodo de tiempo: Up to 12 months
|
Descriptive statistics on participants' satisfaction with the timing, content, and format of the intervention will be presented through summary statistics of data from the satisfaction tools.
|
Up to 12 months
|
Satisfaction of patients' family caregivers with the timing, content, and format of the program
Periodo de tiempo: Up to 12 months
|
Changes from baseline will be tested using paired t-tests.
Descriptive statistics on participants' satisfaction with the timing, content, and format of the intervention will be presented through summary statistics of data from the satisfaction tools.
|
Up to 12 months
|
Benefits for patients' family caregivers after participating in the program, as assessed by the Modified Caregiver Strain Index
Periodo de tiempo: Up to 12 months
|
Data will be summarized using descriptive statistics, including means for normally distributed continuous data, medians for non-normally distributed continuous data or proportions for categorical data.
Established instruments will be scored according to standard instructions, and appropriate descriptive statistics computed.
Written comments from all open ended questions analyzed using content analysis methods.
|
Up to 12 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Thanh Dellinger, MD, City of Hope Medical Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 14359 (Otro identificador: City of Hope Medical Center)
- NCI-2015-00467 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
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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