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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shared Care | Experimental |
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| Usual Care | Other |
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| Non-Randomized | Other | Patients receive all follow-up care at DFCI only (Standard Care). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory A. Abel, MD MPH | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stamford Hospital | Stamford | Connecticut | 06902 | United States | ||
| Northern Light Cancer Center dba Eastern Maine Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39786764 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Shared Care |
Shared Care: 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 |
| FG001 | Usual Care |
Standard Care: The usual care provided by the transplant center at DFCI. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Shared Care |
Shared Care: 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants with complete FACT-BMT responses sufficient to calculate the total FACT-BMT score. | Posted | Mean | Standard Deviation | score on a scale | 180 days |
|
Acute graft-versus-host disease (aGVHD), all-cause mortality and non-relapse mortality (NRM) was collected for the first 100 days of participation (until Day 100).
Adverse event collection was limited to collection of aGVHD and NRM and graded on clinical scales. No other adverse events were collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Shared Care |
Shared Care: 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Grade II-IV aGVHD D100 | Blood and lymphatic system disorders | Non-systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gregory Abel (Principal Investigator) | Dana-Farber Cancer Institute | 617-632-1906 | gregory_abel@dfci.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 16, 2020 | Aug 18, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard Care | Other | The usual care provided by the transplant center at DFCI. |
|
| Bangor |
| Maine |
| 04401 |
| United States |
| New England Cancer Specialists | Brunswick | Maine | 04011 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Dana-Farber at Milford | Milford | Massachusetts | 01757 | United States |
| Dana-Farber at South Shore Hospital | Weymouth | Massachusetts | 02190 | United States |
| Dana-Farber at Londonderry | Londonderry | New Hampshire | 03053 | United States |
| New York Oncology Hematology | Albany | New York | 12206 | United States |
| Lifespan Cancer Institute at Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| BG001 | Usual Care |
Standard Care: The usual care provided by the transplant center at DFCI. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Human leukocyte antigen (HLA) type | Count of Participants | Participants |
|
| OG001 | Usual Care |
Standard Care: The usual care provided by the transplant center at DFCI. |
|
|
| Primary | 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. | Participants with complete EORTC QLQ-C30 response sufficient to calculate global score. | Posted | Mean | Standard Deviation | score on a scale | 180 days |
|
|
|
| Primary | 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. | Posted | Count of Participants | Participants | 100 days |
|
|
|
| 9 |
| 152 |
| 0 |
| 152 |
| 47 |
| 152 |
| EG001 | Usual Care |
Standard Care: The usual care provided by the transplant center at DFCI. | 7 | 150 | 0 | 150 | 45 | 150 |
| Grade I aGVHD D100 | Blood and lymphatic system disorders | Non-systematic Assessment |
|
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