NCT03244826

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
404

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 10, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2022

Completed
2 years until next milestone

Results Posted

Study results publicly available

August 16, 2024

Completed
Last Updated

August 16, 2024

Status Verified

March 1, 2024

Enrollment Period

4.6 years

First QC Date

August 3, 2017

Results QC Date

August 18, 2023

Last Update Submit

March 14, 2024

Conditions

Other Cancer

Keywords

Cancer

Outcome Measures

Primary Outcomes (3)

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

    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.

    180 days

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

    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.

    180 days

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

    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.

    100 days

Study Arms (3)

Shared Care

EXPERIMENTAL

* 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

Usual Care

OTHER

* 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

Non-Randomized

OTHER

Patients receive all follow-up care at DFCI only (Standard Care).

Other: Standard Care

Interventions

Shared CareOTHER

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

Shared Care
Standard CareOTHER

The usual care provided by the transplant center at DFCI.

Non-RandomizedUsual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Stamford Hospital

Stamford, Connecticut, 06902, United States

Location

Northern Light Cancer Center dba Eastern Maine Medical Center

Bangor, Maine, 04401, United States

Location

New England Cancer Specialists

Brunswick, Maine, 04011, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Dana-Farber at Milford

Milford, Massachusetts, 01757, United States

Location

Dana-Farber at South Shore Hospital

Weymouth, Massachusetts, 02190, United States

Location

Dana-Farber at Londonderry

Londonderry, New Hampshire, 03053, United States

Location

New York Oncology Hematology

Albany, New York, 12206, United States

Location

Lifespan Cancer Institute at Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (1)

  • Abel GA, Kim HT, Zackon I, Alyea ET, Bailey AS, Winters JP, Meehan KR, Reagan JL, Walsh JH, Walsh TP, Ivanov A, Faggen MA, Sinclair S, Joyce AC, Close SD, Emmert A, Koreth J, Antin JH, Cutler CS, Ho VT, Soiffer RJ. Shared Local Oncology Care After Allogeneic Hematopoietic Cell Transplantation: A Randomized Clinical Trial. JAMA Oncol. 2025 Mar 1;11(3):268-275. doi: 10.1001/jamaoncol.2024.5786.

    PMID: 39786764DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Limitations and Caveats

The Shared Care randomized clinical trial was limited by its status as a care delivery strategy wherein ability to share care with a local oncologist is heavily dependent on prevailing patient and participating center circumstances. Moreover, the study was not powered to detect QOL difference at earlier timepoints than Day 180.

Results Point of Contact

Title
Dr. Gregory Abel (Principal Investigator)
Organization
Dana-Farber Cancer Institute
gregory_abel@dfci.harvard.edu
617-632-1906

Study Officials

  • Gregory A. Abel, MD MPH

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gregory A. Abel. MD, MPH

Study Record Dates

First Submitted

August 3, 2017

First Posted

August 10, 2017

Study Start

January 1, 2018

Primary Completion

August 22, 2022

Study Completion

August 22, 2022

Last Updated

August 16, 2024

Results First Posted

August 16, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

US(9)