Skip to main content
OpenTrials
Completed

NCT Number: NCT03244826

Shared Care: Patient-Centered Management After Hematopoietic Cell Transplantation

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Other Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stamford Hospital, Stamford, Connecticut, United States

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Shared Care

Other

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

Other

The usual care provided by the transplant center at DFCI.

Primary outcomes

  1. Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT) at Day 180

    Time frame: 180 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.

  2. European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer (EORTC QLQ-C30) at Day 180

    Time frame: 180 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.

  3. 100-day Non-relapse Mortality (NRM) for Patients in Shared Care Versus Usual Care

    Time frame: 100 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.

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Aug 10, 2017
Registry last updated
Aug 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.