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Shared Care: Patient-Centered Management After Hematopoietic Cell Transplantation

Not Applicable
Completed
Conditions
Other Cancer
Interventions
Other: Standard Care
Other: Shared Care
Registration Number
NCT03244826
Lead Sponsor
Dana-Farber Cancer Institute
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

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
404
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Non-RandomizedStandard CarePatients receive all follow-up care at DFCI only (Standard Care).
Usual CareStandard 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.
Shared CareShared 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
Primary Outcome Measures
NameTimeMethod
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer (EORTC QLQ-C30) at Day 180180 days

European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer GLOBAL health status subscale. Higher values (range: 0 to 100) represent higher quality of life. This was selected by a consensus of patient stakeholders.

Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT) at Day 180180 days

Functional Assessment of Cancer Therapy - Bone Marrow Transplantation TOTAL score. The TOTAL score is a summed combination of the Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB), Functional Well-Being (FWB) and Bone Marrow Transplant Subscales (BMTS). Higher scores (range: 0 - 148) represent better transplant-related quality of life. It was selected by a consensus of patient stakeholders as a patient-reported outcome (PRO) for the trial.

100-day Non-relapse Mortality (NRM) for Patients in Shared Care Versus Usual Care100 days

Non-relapse mortality is a common measure to assess early outcomes for stem cell transplant, given that there can be a high level of early mortality from the transplant itself even in the absence of relapse. It is defined as a death occurring while in continuous remission. NRM is reported as a binary outcome.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (9)

Dana-Farber at South Shore Hospital

🇺🇸

Weymouth, Massachusetts, United States

Dana-Farber Cancer Institute

🇺🇸

Boston, Massachusetts, United States

Northern Light Cancer Center dba Eastern Maine Medical Center

🇺🇸

Bangor, Maine, United States

New York Oncology Hematology

🇺🇸

Albany, New York, United States

Lifespan Cancer Institute at Rhode Island Hospital

🇺🇸

Providence, Rhode Island, United States

Dana-Farber at Milford

🇺🇸

Milford, Massachusetts, United States

Dana-Farber at Londonderry

🇺🇸

Londonderry, New Hampshire, United States

New England Cancer Specialists

🇺🇸

Brunswick, Maine, United States

Stamford Hospital

🇺🇸

Stamford, Connecticut, United States

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