Other CancerNCT03244826
Shared Care: Patient-Centered Management After Hematopoietic Cell Transplantation
A study testing Shared Care in people with Other Cancer, run by Dana-Farber Cancer Institute at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Other Cancer
- What is being tested?
- Shared Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 404 participants
- Where
- 9 sitesUnited States
- Study dates
- 1 Jan 2018to 22 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
New York Oncology Hematology
Albany, New York, 12206
Northern Light Cancer Center dba Eastern Maine Medical Center
Bangor, Maine, 04401
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
New England Cancer Specialists
Brunswick, Maine, 04011
Dana-Farber at Londonderry
Londonderry, New Hampshire, 03053
Dana-Farber at Milford
Milford, Massachusetts, 01757
Lifespan Cancer Institute at Rhode Island Hospital
Providence, Rhode Island, 02903
Stamford Hospital
Stamford, Connecticut, 06902
Dana-Farber at South Shore Hospital
Weymouth, Massachusetts, 02190
About this study
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.
Read the 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
- Conditions
- Other Cancer
- Being tested
- Shared Care, Standard Care
- Keywords
- Cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Standard CareOther
The usual care provided by the transplant center at DFCI.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Standard Care |
| Non-Randomized | Other | Patients receive all follow-up care at DFCI only (Standard Care). Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2017
- Study start1 Jan 2018
- Primary completion22 Aug 2022
- Study completion22 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Other CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 404 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregory A. Abel, MD, Dana-Farber Cancer Institute
- Investigators
- Gregory A. Abel, MD MPH, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03244826
- Sponsor's protocol ID
- 17-253
- Status last verified
- Mar 2024
- First submitted
- 3 Aug 2017
- Last updated
- 16 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39786764
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared Care: Patient-Centered Management After Hematopoietic Cell Transplantation
- ClinicalTrials.gov ID
- NCT03244826
- Acronym / sponsor ID
- 17-253
- Conditions
- Other Cancer
- Keywords
- Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 404 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 22 Aug 2022 (actual)
- Study completion
- 22 Aug 2022 (actual)
- First posted
- 10 Aug 2017 (actual)
- Results
- Posted 16 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Shared Care | Experimental | Other: Shared 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 |
| Usual Care | Other | Other: Standard 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. |
| Non-Randomized | Other | Other: Standard CarePatients receive all follow-up care at DFCI only (Standard Care). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shared CareShared 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 | Other | Shared Care |
| Standard CareThe usual care provided by the transplant center at DFCI. | Other | Non-Randomized, Usual Care |
Primary outcome
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39786764Abel 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory A. Abel, MD MPH principal investigator
Dana-Farber Cancer Institute
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shared Care in people with Other Cancer, run by Dana-Farber Cancer Institute at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT) at Day 180 (time frame: 180 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03244826, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2024.