Shared Care: Patient-Centered Management After Hematopoietic Cell Transplantation

Sponsor

Dana-Farber Cancer Institute (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03244826

Collaborator

(none)

404

Enrollment

Locations

Arms

Anticipated Duration (Months)

44.9

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Other Cancer	Other: Shared Care Other: Standard Care	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

404 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Shared Care: Patient-Centered Management After Hematopoietic Cell Transplantation

Actual Study Start Date :

Jan 1, 2018

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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 following Formal Care Coordination Plan Patient Engagement and Education Local Oncologist Engagement and Education Patient/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.

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 following Formal Care Coordination Plan Patient Engagement and Education Local Oncologist Engagement and Education Patient/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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Overall Survival [2 years]
OS
cGVHD [2 years]
cGVHD

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stamford Hospital	Stamford	Connecticut	United States	06902
2	Northern Light Cancer Center dba Eastern Maine Medical Center	Bangor	Maine	United States	04401
3	New England Cancer Specialists	Brunswick	Maine	United States	04011
4	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02215
5	Dana-Farber at Milford	Milford	Massachusetts	United States	01757
6	Dana-Farber at South Shore Hospital	Weymouth	Massachusetts	United States	02190
7	Dana-Farber at Londonderry	Londonderry	New Hampshire	United States	03053
8	New York Oncology Hematology	Albany	New York	United States	12206
9	Lifespan Cancer Institute at Rhode Island Hospital	Providence	Rhode Island	United States	02903

Sponsors and Collaborators

Dana-Farber Cancer Institute

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gregory A. Abel, MD, Gregory A. Abel. MD, MPH, Dana-Farber Cancer Institute

ClinicalTrials.gov Identifier:

NCT03244826

Other Study ID Numbers:

17-253

First Posted:

Aug 10, 2017

Last Update Posted:

Mar 15, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Gregory A. Abel, MD, Gregory A. Abel. MD, MPH, Dana-Farber Cancer Institute

Cancer

Study Results

No Results Posted as of Mar 15, 2022