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Randomized Study of Individualized Care Plans for Hematopoietic Cell Transplant Survivors

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.

Visão geral do estudo

Descrição detalhada

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 estudo

Intervencional

Inscrição (Antecipado)

495

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • 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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Cuidados de suporte
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Sem intervenção: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
Change in Confidence in Survivorship Information instrument score
Prazo: baseline to 6 months after the study intervention
baseline to 6 months after the study intervention

Medidas de resultados secundários

Medida de resultado
Prazo
Change in HCT treatment distress instrument score
Prazo: baseline to 6 months after the study intervention
baseline to 6 months after the study intervention
Change in Health behaviors instrument score
Prazo: baseline to 6 months after the study intervention
baseline to 6 months after the study intervention
Changes in Healthcare utilization instrument score
Prazo: baseline to 6 months after the study intervention
baseline to 6 months after the study intervention
Change in Knowledge about transplant exposures instrument score
Prazo: baseline to 6 months after the study intervention
baseline to 6 months after the study intervention
Change in Quality of life instrument score
Prazo: baseline to 6 months after the study intervention
baseline to 6 months after the study intervention
Change in Self-efficacy instrument score
Prazo: baseline to 6 months after the study intervention
baseline to 6 months after the study intervention

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Cadeira de estudo: Elizabeth Murphy, EdD, RN, National Marrow Donor Program
  • Cadeira de estudo: Navneet Majhail, MD, MS, Cleveland Clinic Foundation; National Marrow Donor Program
  • Cadeira de estudo: K Scott Baker, MD, MS, Fred Hutchinson Cancer Center

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de abril de 2015

Conclusão Primária (Real)

1 de abril de 2017

Conclusão do estudo (Real)

1 de abril de 2017

Datas de inscrição no estudo

Enviado pela primeira vez

21 de julho de 2014

Enviado pela primeira vez que atendeu aos critérios de CQ

24 de julho de 2014

Primeira postagem (Estimativa)

25 de julho de 2014

Atualizações de registro de estudo

Última Atualização Postada (Real)

7 de setembro de 2017

Última atualização enviada que atendeu aos critérios de controle de qualidade

5 de setembro de 2017

Última verificação

1 de setembro de 2017

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • 13-SCP

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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