Clinical trial NCT03244826: Shared Care: Patient-Centered Management After Hematopoietic Cell Transplantation
Official title: Shared Care: Patient-Centered Management After Hematopoietic Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Other Cancer
Keywords: Cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2017-08-10
Enrollment: 404
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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

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

Primary outcomes:
measure: Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT) at Day 180
timeFrame: 180 days
measure: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer (EORTC QLQ-C30) at Day 180
timeFrame: 180 days
measure: 100-day Non-relapse Mortality (NRM) for Patients in Shared Care Versus Usual Care
timeFrame: 100 days
Secondary outcomes:
Other outcomes:
Locations:
city: Stamford
country: United States
facility: Stamford Hospital
state: Connecticut
city: Bangor
country: United States
facility: Northern Light Cancer Center dba Eastern Maine Medical Center
state: Maine
city: Brunswick
country: United States
facility: New England Cancer Specialists
state: Maine
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Milford
country: United States
facility: Dana-Farber at Milford
state: Massachusetts
city: Weymouth
country: United States
facility: Dana-Farber at South Shore Hospital
state: Massachusetts
city: Londonderry
country: United States
facility: Dana-Farber at Londonderry
state: New Hampshire
city: Albany
country: United States
facility: New York Oncology Hematology
state: New York
city: Providence
country: United States
facility: Lifespan Cancer Institute at Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Gregory A. Abel, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: