Other Cancer
Conditions
Keywords
Cancer
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
Interventions
OTHERShared 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
OTHERStandard Care
The usual care provided by the transplant center at DFCI.
Sponsors
Dana-Farber Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT) at Day 180 | 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 | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
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 | 152 |
| Usual 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.
Standard Care: The usual care provided by the transplant center at DFCI. | 150 |
| Total | 302 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Transplant delayed or withdrawn | 12 | 10 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Total | Shared Care | Usual Care |
|---|---|---|---|
| Age, Continuous | 63 years | 63 years | 62 years |
| Human leukocyte antigen (HLA) type Matched Related | 47 Participants | 28 Participants | 19 Participants |
| Human leukocyte antigen (HLA) type Matched Unrelated | 181 Participants | 87 Participants | 94 Participants |
| Human leukocyte antigen (HLA) type Mismatched | 37 Participants | 19 Participants | 18 Participants |
| Human leukocyte antigen (HLA) type Unknown/Other | 37 Participants | 18 Participants | 19 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 12 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) White | 277 Participants | 141 Participants | 136 Participants |
| Region of Enrollment United States | 302 participants | 152 participants | 150 participants |
| Sex: Female, Male Female | 117 Participants | 53 Participants | 64 Participants |
| Sex: Female, Male Male | 185 Participants | 99 Participants | 86 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 9 / 152 | 7 / 150 |
| other Total, other adverse events | 47 / 152 | 45 / 150 |
| serious Total, serious adverse events | 0 / 152 | 0 / 150 |
Outcome results
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.
Time frame: 100 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Shared Care | 100-day Non-relapse Mortality (NRM) for Patients in Shared Care Versus Usual Care | 4 Participants |
| Usual Care | 100-day Non-relapse Mortality (NRM) for Patients in Shared Care Versus Usual Care | 4 Participants |
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.
Time frame: 180 days
Population: Participants with complete EORTC QLQ-C30 response sufficient to calculate global score.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Shared Care | European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer (EORTC QLQ-C30) at Day 180 | 68.93 score on a scale | Standard Deviation 20.6 |
| Usual Care | European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer (EORTC QLQ-C30) at Day 180 | 67.01 score on a scale | Standard Deviation 20.76 |
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.
Time frame: 180 days
Population: Participants with complete FACT-BMT responses sufficient to calculate the total FACT-BMT score.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Shared Care | Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT) at Day 180 | 110.68 score on a scale | Standard Deviation 18.34 |
| Usual Care | Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT) at Day 180 | 106.89 score on a scale | Standard Deviation 20.42 |