- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02200133
Randomized Study of Individualized Care Plans for Hematopoietic Cell Transplant Survivors
Visão geral do estudo
Status
Intervenção / Tratamento
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
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
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
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
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
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)
|
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)
|
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
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
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
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 .