Shared Care: Patient-Centered Management After Hematopoietic Cell Transplantation

This research study aims to evaluate the effectiveness of allowing patients who have had a hematopoietic cell transplant to receive some of their post-transplant care with a local oncologist rather than returning to the transplant center for all of their follow-up.

Study Overview

• Status: Completed
• Conditions: Other Cancer
• Intervention / Treatment: Other: Shared Care; Other: Standard Care

Detailed Description

Hematopoietic Cell Transplantation (HCT) - also known as bone marrow transplant - is only available at select centers in the United States which can collect and store stem cells, as well as care for patients before their new immune system cells take hold. For this reason, many patients who undergo HCT live at great distances from their HCT center. Also, after hospital discharge, the first 180 days post-HCT are very important, as patients must be managed closely with frequent follow-up visits.

A potential way to make life easier for HCT patients is to allow some of the post-transplant care to be provided by local oncologists who practice closer to where patients live. This could reduce the burden on patients and their caregivers; however, it is not known if a shared care model would ultimately benefit them. The investigators want to assess the effectiveness of a Shared Care program which allows patients to receive half of their post-HCT care at the HCT center, and the other half with their local oncologist

• Study Type: Interventional
• Enrollment (Actual): 404
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Stamford, Connecticut, United States, 06902
      • Stamford Hospital
  • Maine
    • Bangor, Maine, United States, 04401
      • Northern Light Cancer Center dba Eastern Maine Medical Center
    • Brunswick, Maine, United States, 04011
      • New England Cancer Specialists
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute
    • Milford, Massachusetts, United States, 01757
      • Dana-Farber at Milford
    • Weymouth, Massachusetts, United States, 02190
      • Dana-Farber at South Shore Hospital
  • New Hampshire
    • Londonderry, New Hampshire, United States, 03053
      • Dana-Farber at Londonderry
  • New York
    • Albany, New York, United States, 12206
      • New York Oncology Hematology
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Lifespan Cancer Institute at Rhode Island Hospital

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:

• Age >= 18 years of age
• Scheduled to receive an allogeneic HCT at the Dana-Farber Inpatient Hospital or BWH under the care of a DFCI physician
• Residence in New York, Maine, New Hampshire, Vermont, Connecticut, or Massachusetts
• Referred from or live less than 1 hour from one of the local participating centers.
• Ability to read English (to fill out standard QOL forms)

Exclusion Criteria:

• Age <18 years of age
• Scheduled to receive an autologous HCT
• Has received an allogeneic transplant in the past; scheduled to receive a second allogeneic transplant
• Did not receive an allogeneic HCT at Dana-Farber
• Does not live in New York, Maine, New Hampshire, Vermont, Connecticut, or Massachusetts

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shared Care; For the first 90 days, patients alternate between local oncologist and DFCI for weekly visits.; From 90 to 180 days, patients alternate between local and DFCI every 2-3 weeks.; Shared Care include the followingFormal Care Coordination PlanPatient Engagement and EducationLocal Oncologist Engagement and EducationPatient/Local Oncologist/Transplant Oncologist Web Portal	Other: Shared Care; Shared Care involves four specific strategies to allow patients to have a portion of their care locally after HCT, where clinic and laboratory visits are equally shared between the local oncologist and primary HCT team
Other: Usual Care; Patients receive all follow-up care at DFCI only, which is currently the Standard Care.; Majority of routine visits in first 180 days will be at DFCI.	Other: Standard Care; The usual care provided by the transplant center at DFCI.
Other: Non-Randomized; Patients receive all follow-up care at DFCI only (Standard Care).	Other: Standard Care; The usual care provided by the transplant center at DFCI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Highly-relevant PROs for Shared versus Usual Care at 180 days post-HCT	Fact-BMT (standard measure of transplant-related quality of life)	180 days
Highly-relevant PROs for Shared versus Usual Care at 180 days post-HCT	EORTC QLQ-C30 (standard measure of cancer-related quality of life)	180 days
Highly-relevant PROs for Shared versus Usual Care at 180 days post-HCT	Dana-Farber post-transplant Survey (questionnaire developed to measure financial hardship after transplant; See Abel, et al BBMT, 2016)	180 days
100-day non-relapse mortality (NRM) for patients in Shared Care versus Usual Care	NRM	100 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	OS	2 years
cGVHD	cGVHD	2 years

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Investigators: Principal Investigator: Gregory A. Abel, MD MPH, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): August 22, 2022
• Study Completion (Actual): August 22, 2022

Study Registration Dates

• First Submitted: August 3, 2017
• First Submitted That Met QC Criteria: August 7, 2017
• First Posted (Actual): August 10, 2017

Study Record Updates

• Last Update Posted (Actual): November 2, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Cancer
• Other Study ID Numbers: 17-253

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No