- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02816866
Comparing Two Modes of Survivorship Care
Comparing Two Modes of Survivorship Care: A Randomized Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Although 80% of children with cancer will be cured of their primary disease, at least 70% of survivors will develop chronic medical, neurocognitive, and/or emotional conditions as a complication of their therapy. Most of these conditions are amenable to prevention and early intervention. In response, the Institute of Medicine strongly advised that all cancer patients should receive survivorship care with the following key elements: 1) a summary of previous cancer therapy, 2) individualized life-long screening for potential adverse therapy-related effects, and 3) education regarding desirable health behaviors. However, less than 30% of survivors receive recommended care. There is a tremendous need for research that addresses how to best implement evidence-based recommendations for this population.
Two main health care delivery models have been advocated for survivorship care, but no comparison studies exist. The first model is a specialty survivor clinic, usually at a cancer treatment center. The second model, termed the empowered primary care model, involves patients receiving an individualized "prescription" for follow-up care prepared by a cancer survivor specialist to be implemented by the primary care doctor. Each model poses unique strengths and weaknesses. Specialty survivor clinics can be expensive and geographically inaccessible, can cause anxiety and stress to patients, and can accommodate limited numbers of patients. Primary care doctors may lack adequate expertise and time for these complex patients. Unless we know how these approaches compare with regard to quality of care and risks, advocates and policy makers will be stymied in their efforts to support the health needs of cancer survivors. This study seeks to compare subjects randomized to the empowered primary care model vs. a specialty survivor clinic.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Diagnosis of any malignancy at age <18 years and reported to Yale-New Haven Hospital or Connecticut Children's Medical Center (CCMC) tumor registry
- Currently alive and cancer-free
- Primary residence within approximately 100 miles of Yale-New Haven Hospital or CCMC
- ≥ 1 year status post completion of all cancer-related therapy
- Elapsed time of less than 12.0 years since diagnosis of malignancy
- Speaking and writing knowledge of English. For subjects <18 years, at least one parent must satisfy this requirement.
- No previous attendance at the Yale HEROS or CCMC Reach for the STARS survivorship clinics, or other specialty survivorship clinic
Exclusion Criteria:
- n/a
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: empowered primary care model
patients receive an individualized "prescription" for survivorship care prepared by a cancer survivor specialist to be implemented by the primary care doctor
|
mode of survivorship care
|
|
Experimental: specialty survivor clinic
patient attends a specialty survivor clinic at Yale for survivorship care
|
mode of survivorship care
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
adherence to guideline-recommended surveillance (medical record abstraction)
Periodo de tiempo: 12 months post-intervention
|
quality of survivorship care
|
12 months post-intervention
|
|
number of newly-identified late effects of therapy (medical record abstraction)
Periodo de tiempo: 12 months post-intervention
|
quality of survivorship care
|
12 months post-intervention
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
anxiety (Brief Symptom Inventory (BSI))
Periodo de tiempo: 12 months post-intervention
|
adverse effects of receiving survivorship care
|
12 months post-intervention
|
|
depression (Behavior Assessment System for Children, 2nd Edition (BASC-2))
Periodo de tiempo: 12 months post-intervention
|
adverse effects of receiving survivorship care
|
12 months post-intervention
|
|
post-traumatic stress symptoms (Post-Traumatic Stress Disorder Reaction Index (PTSD-RI))
Periodo de tiempo: 12 months post-intervention
|
adverse effects of receiving survivorship care
|
12 months post-intervention
|
|
level of physical activity (2008 questionnaires of the Behavioral Risk Factor Surveillance System (BRFSS))
Periodo de tiempo: 12 months post-intervention
|
adherence to desirable health behaviors
|
12 months post-intervention
|
|
avoidance of tobacco (2008 questionnaires of the Behavioral Risk Factor Surveillance System (BRFSS))
Periodo de tiempo: 12 months post-intervention
|
adherence to desirable health behaviors
|
12 months post-intervention
|
|
intake of at least five servings per day of fruits and vegetables (2008 questionnaires of the Behavioral Risk Factor Surveillance System (BRFSS))
Periodo de tiempo: 12 months post-intervention
|
adherence to desirable health behaviors
|
12 months post-intervention
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Nina S Kadan-Lottick, MD, MSPH, Yale School of Medicine
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
Palabras clave
Otros números de identificación del estudio
- 1007007080
- 119700-RSGHP-10-107-01-CPHPS (Otro número de subvención/financiamiento: American Cancer Society)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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. .