Shared Care: Patient-Centered Management After Hematopoietic Cell Transplantation

NCT ID: NCT03244826

Last Updated: 2024-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 404 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2022-08-22

Brief Summary

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.

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

Conditions

Other Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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 following

• Formal Care Coordination Plan
• Patient Engagement and Education
• Local Oncologist Engagement and Education
• Patient/Local Oncologist/Transplant Oncologist Web Portal

Group Type: EXPERIMENTAL

Shared Care

Intervention Type: OTHER

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

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.

Group Type: OTHER

Standard Care

Intervention Type: OTHER

The usual care provided by the transplant center at DFCI.

Non-Randomized

Patients receive all follow-up care at DFCI only (Standard Care).

Group Type: OTHER

Standard Care

Intervention Type: OTHER

The usual care provided by the transplant center at DFCI.

Interventions

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

Intervention Type: OTHER

Standard Care

The usual care provided by the transplant center at DFCI.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Gregory A. Abel, MD

Gregory A. Abel. MD, MPH

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gregory A. Abel, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Stamford Hospital

Stamford, Connecticut, United States

Northern Light Cancer Center dba Eastern Maine Medical Center

Bangor, Maine, United States

New England Cancer Specialists

Brunswick, Maine, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Dana-Farber at Milford

Milford, Massachusetts, United States

Dana-Farber at South Shore Hospital

Weymouth, Massachusetts, United States

Dana-Farber at Londonderry

Londonderry, New Hampshire, United States

New York Oncology Hematology

Albany, New York, United States

Lifespan Cancer Institute at Rhode Island Hospital

Providence, Rhode Island, United States

Countries

United States

References

Abel GA, Kim HT, Zackon I, Alyea ET, Bailey AS, Winters JP, Meehan KR, Reagan JL, Walsh JH, Walsh TP, Ivanov A, Faggen MA, Sinclair S, Joyce AC, Close SD, Emmert A, Koreth J, Antin JH, Cutler CS, Ho VT, Soiffer RJ. Shared Local Oncology Care After Allogeneic Hematopoietic Cell Transplantation: A Randomized Clinical Trial. JAMA Oncol. 2025 Mar 1;11(3):268-275. doi: 10.1001/jamaoncol.2024.5786.

Reference Type: DERIVED

PMID: 39786764 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

17-253

Identifier Type: -

Identifier Source: org_study_id