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.

Study Overview

• Status: Completed
• Conditions: Adult Hematopoietic Cell Transplant (HCT) Survivors 1-2 Yrs Post Most Recent HCT
• Intervention / Treatment: Other: Individualized Survivorship Care Plan (SCP)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 495
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)	Other: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Confidence in Survivorship Information instrument score	baseline to 6 months after the study intervention

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in HCT treatment distress instrument score	baseline to 6 months after the study intervention
Change in Health behaviors instrument score	baseline to 6 months after the study intervention
Changes in Healthcare utilization instrument score	baseline to 6 months after the study intervention
Change in Knowledge about transplant exposures instrument score	baseline to 6 months after the study intervention
Change in Quality of life instrument score	baseline to 6 months after the study intervention
Change in Self-efficacy instrument score	baseline to 6 months after the study intervention

Collaborators and Investigators

• Sponsor: Center for International Blood and Marrow Transplant Research
• Collaborators: Patient-Centered Outcomes Research Institute; National Marrow Donor Program
• Investigators: Study Chair: Elizabeth Murphy, EdD, RN, National Marrow Donor Program; Study Chair: Navneet Majhail, MD, MS, Cleveland Clinic Foundation; National Marrow Donor Program; Study Chair: K Scott Baker, MD, MS, Fred Hutchinson Cancer Center

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: July 21, 2014
• First Submitted That Met QC Criteria: July 24, 2014
• First Posted (Estimate): July 25, 2014

Study Record Updates

• Last Update Posted (Actual): September 7, 2017
• Last Update Submitted That Met QC Criteria: September 5, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Survivorship Care Plan; Hematopoietic cell transplant (HCT) survivors
• Other Study ID Numbers: 13-SCP