- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02200133
Randomized Study of Individualized Care Plans for Hematopoietic Cell Transplant Survivors
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
This randomized study will compare a personalized Survivorship Care Plan (SCP) template with usual care (no SCP). The investigators hypothesize that the personalized SCP that incorporates patient specific treatment exposures and provides a framework for long term followup based on those exposures and subsequent risks for late complications will enhance patient survivorship confidence in knowledge, increase adherence to recommended healthcare, improve health behaviors and reduce hematopoietic cell transplant (HCT) - related emotional distress.
The randomized study design will be able to evaluate the efficacy of individualized SCP in enhancing transplant survivor knowledge, health behaviors and health care utilization for recommended preventive care. Most transplant centers do not use a standardized SCP for their HCT recipients, and hence, the control arm would represent prevalent standard of care (e.g., discharge summary, provider-to-provider communication).
Transplant centers that will participate in this study will represent a spectrum of center types (e.g., geographic location, center volume, resources and infrastructure) and patient populations (e.g., healthcare disparities, urban/rural population, distance from transplant center). Usual care for each center will be documented at the time of determining center eligibility. The study principal investigators, in consultation with the protocol team, will make the determination about center eligibility after reviewing the centers "usual care" procedures. In order to avoid contamination of the study intervention, centers will be asked not to change their follow-up practices for the period they are enrolling patients on the study.
The primary objective of the investigators study is to evaluate the impact of an individualized SCP on survivor knowledge about past diagnostic and treatment details, confidence in knowledge about prevention and treatment of late-effects, access to resources and familial risk of cancer. For this objective, the investigators will compare the change in score on the Confidence in Survivorship Information instrument from baseline to 6 months after the study intervention.
Secondary objectives will investigate the influence of individualized SCP on standardized measures of HCT related distress, knowledge of recommended care, health behaviors, self-efficacy, and health care utilization.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Arizona
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Scottsdale, Arizona, Estados Unidos, 85259-5499
- Mayo Clinic
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Florida
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Gainesville, Florida, Estados Unidos, 32608
- University of Florida, Shands Hospital
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Illinois
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Maywood, Illinois, Estados Unidos, 60153
- Loyola Medical Center
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Kansas
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Westwood, Kansas, Estados Unidos, 66205
- University of Kansas Cancer Center
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Massachusetts
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Worcester, Massachusetts, Estados Unidos, 01655
- University of Massachusetts Memorial Medical Center
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Michigan
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Detroit, Michigan, Estados Unidos, 48201
- Karmanos Cancer Institute
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55455
- University of Minnesota Medical Center
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic Rochester
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New York
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Buffalo, New York, Estados Unidos, 14263
- Roswell Park Cancer Institute
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599
- UNC Chapel Hill
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Ohio
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Cleveland, Ohio, Estados Unidos, 44195
- Cleveland Clinic
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Cleveland, Ohio, Estados Unidos, 44106
- University Hospitals Case Medical Center
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Columbus, Ohio, Estados Unidos, 43210
- Ohio State University
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- University of Pennsylvania
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37232
- Vanderbilt-Ingram Cancer Center
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Texas
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Dallas, Texas, Estados Unidos, 75246
- Baylor University Medical Center
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Washington
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Seattle, Washington, Estados Unidos, 98109
- Fred Hutchinson Cancer Research Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Adult (≥ 18 years at time of allogeneic HCT recipient at participating transplant centers)
- Survival 1-2 years after most recent HCT with no evidence of relapse, disease progression, or secondary cancer on last follow-up
- All diagnoses will be eligible
- All transplant types will be eligible (autologous or allogeneic related or unrelated)
- All graft sources will be eligible (bone marrow, peripheral blood or umbilical cord blood)
- All conditioning regimens will be eligible (in case of allogeneic HCT, patient could have received myeloablative or non-myeloablative/reduced-intensity conditioning)
- Patient may have received more than one HCT
- Patient must be proficient in English (written and spoken) to complete study assessments
- Patient must have a valid mailing address within the United States to receive study materials
- Signed informed consent form from patient
Exclusion Criteria:
- Patients who have received their transplant at a different transplant center will not be eligible for the study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Individualized Survivorship Care Plan (SCP)
|
The individualized SCP incorporates patient specific treatment exposures and provides a framework for long term followup based on those exposures and subsequent risks for late complications.
|
Sin intervención: Usual care (no SCP)
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Change in Confidence in Survivorship Information instrument score
Periodo de tiempo: baseline to 6 months after the study intervention
|
baseline to 6 months after the study intervention
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Change in HCT treatment distress instrument score
Periodo de tiempo: baseline to 6 months after the study intervention
|
baseline to 6 months after the study intervention
|
Change in Health behaviors instrument score
Periodo de tiempo: baseline to 6 months after the study intervention
|
baseline to 6 months after the study intervention
|
Changes in Healthcare utilization instrument score
Periodo de tiempo: baseline to 6 months after the study intervention
|
baseline to 6 months after the study intervention
|
Change in Knowledge about transplant exposures instrument score
Periodo de tiempo: baseline to 6 months after the study intervention
|
baseline to 6 months after the study intervention
|
Change in Quality of life instrument score
Periodo de tiempo: baseline to 6 months after the study intervention
|
baseline to 6 months after the study intervention
|
Change in Self-efficacy instrument score
Periodo de tiempo: baseline to 6 months after the study intervention
|
baseline to 6 months after the study intervention
|
Colaboradores e Investigadores
Investigadores
- Silla de estudio: Elizabeth Murphy, EdD, RN, National Marrow Donor Program
- Silla de estudio: Navneet Majhail, MD, MS, Cleveland Clinic Foundation; National Marrow Donor Program
- Silla de estudio: K Scott Baker, MD, MS, Fred Hutchinson Cancer 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
Otros números de identificación del estudio
- 13-SCP
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. .
Ensayos clínicos sobre Individualized Survivorship Care Plan (SCP)
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University Health Network, TorontoMcGill University Health Centre/Research Institute of the McGill University... y otros colaboradoresTerminado
-
UNC Lineberger Comprehensive Cancer CenterUniversity of North Carolina, Chapel HillTerminado
-
Fondazione Italiana Linfomi - ETSAún no reclutandoLinfoma de Hodgkin clásico | Linfoma primario de células B grandes del mediastino (PMBCL) | Linfoma difuso de células B grandes (DLBCL)Italia
-
Indiana UniversityNational Cancer Institute (NCI)ReclutamientoCáncerEstados Unidos
-
NRG OncologyNational Cancer Institute (NCI)Activo, no reclutandoSobreviviente de cáncer | Adenocarcinoma de próstataEstados Unidos
-
University of Illinois at ChicagoFogarty International Center of the National Institute of HealthTerminadoCáncer de cuello uterino | ComportamientoEstados Unidos, Senegal