Shared Care: Patient-Centered Management After Hematopoietic Cell Transplantation

Other Cancer Clinical Trial

Official title:

Shared Care: Patient-Centered Management After Hematopoietic Cell Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03244826
• Other study ID #: 17-253
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: August 22, 2022

Study information

• Verified date: November 2022
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 404
• Est. completion date: August 22, 2022
• Est. primary completion date: August 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Other Cancer

Intervention

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
• Standard Care
The usual care provided by the transplant center at DFCI.

Locations

Country	Name	City	State
United States	New York Oncology Hematology	Albany	New York
United States	Northern Light Cancer Center dba Eastern Maine Medical Center	Bangor	Maine
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	New England Cancer Specialists	Brunswick	Maine
United States	Dana-Farber at Londonderry	Londonderry	New Hampshire
United States	Dana-Farber at Milford	Milford	Massachusetts
United States	Lifespan Cancer Institute at Rhode Island Hospital	Providence	Rhode Island
United States	Stamford Hospital	Stamford	Connecticut
United States	Dana-Farber at South Shore Hospital	Weymouth	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	100-day non-relapse mortality (NRM) for patients in Shared Care versus Usual Care	NRM	100 days
Secondary	Overall Survival	OS	2 years
Secondary	cGVHD	cGVHD	2 years