Shared Care: Patient-Centered Management After Hematopoietic Cell Transplantation

Study Overview
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Brief Summary
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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
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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

Official Title
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Shared Care: Patient-Centered Management After Hematopoietic Cell Transplantation

Conditions
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Other Cancer

Intervention / Treatment
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* Other: Shared Care
* Other: Standard Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shared Care<br>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<br>* 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<br>|
| Other: Usual Care<br>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<br>* The usual care provided by the transplant center at DFCI.<br>|
| Other: Non-Randomized<br>Patients receive all follow-up care at DFCI only (Standard Care). | Other: Standard Care<br>* The usual care provided by the transplant center at DFCI.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer