Clinical trial NCT02200133: Randomized Study of Individualized Care Plans for Hematopoietic Cell Transplant Survivors
Official title: Randomized Study of Individualized Care Plans for Hematopoietic Cell Transplant Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adult Hematopoietic Cell Transplant (HCT) Survivors 1-2 Yrs Post Most Recent HCT
Keywords: Hematopoietic cell transplant (HCT) survivors
Survivorship Care Plan
Lead sponsor: Center for International Blood and Marrow Transplant Research
Sponsor class: NETWORK
Collaborators: name: Patient-Centered Outcomes Research Institute
name: National Marrow Donor Program
First posted: 2014-07-25
Enrollment: 495
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Confidence in Survivorship Information instrument score
timeFrame: baseline to 6 months after the study intervention
Secondary outcomes:
measure: Change in HCT treatment distress instrument score
timeFrame: baseline to 6 months after the study intervention
measure: Change in Health behaviors instrument score
timeFrame: baseline to 6 months after the study intervention
measure: Changes in Healthcare utilization instrument score
timeFrame: baseline to 6 months after the study intervention
measure: Change in Knowledge about transplant exposures instrument score
timeFrame: baseline to 6 months after the study intervention
measure: Change in Quality of life instrument score
timeFrame: baseline to 6 months after the study intervention
measure: Change in Self-efficacy instrument score
timeFrame: baseline to 6 months after the study intervention
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
city: Gainesville
country: United States
facility: University of Florida, Shands Hospital
state: Florida
city: Maywood
country: United States
facility: Loyola Medical Center
state: Illinois
city: Westwood
country: United States
facility: University of Kansas Cancer Center
state: Kansas
city: Worcester
country: United States
facility: University of Massachusetts Memorial Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Chapel Hill
country: United States
facility: UNC Chapel Hill
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
Study officials:
affiliation: National Marrow Donor Program
name: Elizabeth Murphy, EdD, RN
role: STUDY_CHAIR
affiliation: Cleveland Clinic Foundation; National Marrow Donor Program
name: Navneet Majhail, MD, MS
role: STUDY_CHAIR
affiliation: Fred Hutchinson Cancer Center
name: K Scott Baker, MD, MS
role: STUDY_CHAIR
References: