Randomized Study of Individualized Care Plans for Hematopoietic Cell Transplant Survivors
NCT ID: NCT02200133
Last Updated: 2017-09-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
495 participants
INTERVENTIONAL
2015-04-30
2017-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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)
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.
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
National Marrow Donor Program
OTHER
Center for International Blood and Marrow Transplant Research
NETWORK
Responsible Party
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Principal Investigators
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Elizabeth Murphy, EdD, RN
Role: STUDY_CHAIR
National Marrow Donor Program
Navneet Majhail, MD, MS
Role: STUDY_CHAIR
Cleveland Clinic Foundation; National Marrow Donor Program
K Scott Baker, MD, MS
Role: STUDY_CHAIR
Fred Hutchinson Cancer Center
Locations
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Mayo Clinic
Scottsdale, Arizona, United States
University of Florida, Shands Hospital
Gainesville, Florida, United States
Loyola Medical Center
Maywood, Illinois, United States
University of Kansas Cancer Center
Westwood, Kansas, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
UNC Chapel Hill
Chapel Hill, North Carolina, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Baylor University Medical Center
Dallas, Texas, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Countries
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Other Identifiers
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13-SCP
Identifier Type: -
Identifier Source: org_study_id
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