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Randomized Study of Individualized Care Plans for Hematopoietic Cell Transplant Survivors

2017년 9월 5일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (예상)

495

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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)
다른: 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.
간섭 없음: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Change in Confidence in Survivorship Information instrument score
기간: baseline to 6 months after the study intervention
baseline to 6 months after the study intervention

2차 결과 측정

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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Center for International Blood and Marrow Transplant Research

협력자

Patient-Centered Outcomes Research Institute
National Marrow Donor Program

수사관

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

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2015년 4월 1일

기본 완료 (실제)

2017년 4월 1일

연구 완료 (실제)

2017년 4월 1일

연구 등록 날짜

최초 제출

2014년 7월 21일

QC 기준을 충족하는 최초 제출

2014년 7월 24일

처음 게시됨 (추정)

2014년 7월 25일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2017년 9월 7일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 9월 5일

마지막으로 확인됨

2017년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

기타 연구 ID 번호

  • 13-SCP

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