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Randomized Study of Individualized Care Plans for Hematopoietic Cell Transplant Survivors

5 de septiembre de 2017 actualizado por: Center for International Blood and Marrow Transplant Research
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 HCT-related emotional distress.

Descripción general del estudio

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

Intervencionista

Inscripción (Anticipado)

495

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Arizona
      • Scottsdale, Arizona, Estados Unidos, 85259-5499
        • Mayo Clinic
    • Florida
      • Gainesville, Florida, Estados Unidos, 32608
        • University of Florida, Shands Hospital
    • Illinois
      • Maywood, Illinois, Estados Unidos, 60153
        • Loyola Medical Center
    • Kansas
      • Westwood, Kansas, Estados Unidos, 66205
        • University of Kansas Cancer Center
    • Massachusetts
      • Worcester, Massachusetts, Estados Unidos, 01655
        • University of Massachusetts Memorial Medical Center
    • Michigan
      • Detroit, Michigan, Estados Unidos, 48201
        • Karmanos Cancer Institute
    • Minnesota
      • Minneapolis, Minnesota, Estados Unidos, 55455
        • University of Minnesota Medical Center
      • Rochester, Minnesota, Estados Unidos, 55905
        • Mayo Clinic Rochester
    • New York
      • Buffalo, New York, Estados Unidos, 14263
        • Roswell Park Cancer Institute
    • North Carolina
      • Chapel Hill, North Carolina, Estados Unidos, 27599
        • UNC Chapel Hill
    • Ohio
      • Cleveland, Ohio, Estados Unidos, 44195
        • Cleveland Clinic
      • Cleveland, Ohio, Estados Unidos, 44106
        • University Hospitals Case Medical Center
      • Columbus, Ohio, Estados Unidos, 43210
        • Ohio State University
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19104
        • University of Pennsylvania
    • Tennessee
      • Nashville, Tennessee, Estados Unidos, 37232
        • Vanderbilt-Ingram Cancer Center
    • Texas
      • Dallas, Texas, Estados Unidos, 75246
        • Baylor University Medical Center
    • Washington
      • Seattle, Washington, Estados Unidos, 98109
        • Fred Hutchinson Cancer Research Center

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

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

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿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)
  • Participant information sheet and instructions on how to use the SCP
  • Patient version of individualized SCP that includes but is not limited to: (1) a treatment summary that consists of disease characteristics and treatment details (including HCT), and (2) recommendations for preventive care and screening for late complications based on patient treatment exposures (age, type of transplant, use of TBI, corticosteroid exposure as part of HCT, and history of GVHD)
  • Newest Vital Sign nutrition label to measure health literacy and its instructions
  • Participants may receive other materials their transplant center routinely provides to patients for follow-up care (e.g., discharge summary or clinic note)
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)
  • Materials that their transplant center routinely provides to patients for follow-up care
  • Newest Vital Sign nutrition label to measure health literacy and its instructions
  • Participants randomized to the usual care arm who complete the 6 month study assessments will receive their individualized SCP upon completion of the patient's participation. Participants who withdraw from the study or who do not complete the 6 month assessment will not receive the individualized 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

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

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de abril de 2015

Finalización primaria (Actual)

1 de abril de 2017

Finalización del estudio (Actual)

1 de abril de 2017

Fechas de registro del estudio

Enviado por primera vez

21 de julio de 2014

Primero enviado que cumplió con los criterios de control de calidad

24 de julio de 2014

Publicado por primera vez (Estimar)

25 de julio de 2014

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

7 de septiembre de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

5 de septiembre de 2017

Última verificación

1 de septiembre de 2017

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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