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Hospice care at the end of life (EOL) includes a multidisciplinary team that helps patients and families focus on symptom control and quality of life. For patients with "solid" (e.g. lung, breast) cancers it has been shown to improve quality of life for both patients and families. Unfortunately, patients with blood cancers (e.g. leukemia, lymphoma) often delay their enrollment and receive more aggressive care at the EOL. One factor in this delay is the inability for patients to receive blood transfusions while on hospice. Patients with blood cancers often require frequent blood transfusions near the EOL for symptom control. The structure of Medicare hospice benefit makes coverage for transfusions financially unfeasible for hospice agencies, and therefore patients with blood cancers will delay enrollment onto hospice in order to continue to receive blood transfusions.
The objective of this study is to evaluate whether removing this financial burden, through external funding of blood transfusions for patients while on hospice, will encourage patients with blood cancers to enroll on hospice earlier and ultimately improve their and their caregivers EOL care.
The overall objective is to demonstrate the feasibility of providing blood transfusions to patients with HM enrolled on hospice, and to evaluate both EOL care quality outcomes in these patients, and caregiver quality of life and perception of patient EOL care quality. Palliative blood transfusions will be provided to patients on this study free of cost through study funding. The hypothesis is that removing transfusion dependence as a barrier to hospice enrollment for patients with hematologic malignancies will result in improved EOL care quality outcomes. This hypothesis is derived from our previous research demonstrating that for Medicare beneficiaries with HM, transfusion dependence poses a significant barrier to timely hospice referral.
The study design is to conduct a single-center, prospective pilot study . Patients with aggressive hematologic malignancies who are hospice eligible, not pursuing further cancer directed therapy, and whose primary hematologist is planning to initiate a conversation regarding transition to hospice will be pursued for enrollment. These patients will be offered to enroll in this study in which funding will be provided to receive palliative blood transfusions while enrolled on hospice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Experimental | Patients with aggressive hematologic malignancies who are hospice eligible, not pursuing further cancer directed therapy, and whose primary hematologist is planning to initiate a conversation regarding transition to hospice will be eligible for enrollment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transfusion support | Other | Patients will be offered symptom-driven transfusion support in addition to standard hospice care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Eligible Patients Choosing to Participate in the Care Model Under Study Rather Than Standard of Care. | Measured as: the number of eligible patients approached and number who elect to enter the study and participate in the novel care model rather than through the traditional hospice care model. | Through study completion, on average 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time Enrolled on Hospice. | Count endpoint: number of days enrolled on hospice | From enrollment until death or withdrawal of consent, on average 2 months. |
| Number of Days in the ICU in the Last 30 Days of Life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pamela C Egan, MD | Rhode Island Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
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| Label | URL |
|---|---|
| Cancer Research and Clinical Trials at Lifespan Cancer Institute | View source |
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Of 22 patients and 9 caregivers screened, 10 patients (45%) and 8 caregivers enrolled. 4 screened patients died before consenting.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Arm | Patients with aggressive hematologic malignancies who are hospice eligible, not pursuing further cancer directed therapy, and whose primary hematologist is planning to initiate a conversation regarding transition to hospice will be eligible for enrollment. Transfusion support: Patients will be offered symptom-driven transfusion support in addition to standard hospice care |
| FG001 | Caregivers | Patient caregivers |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Arm | Patients with aggressive hematologic malignancies who are hospice eligible, not pursuing further cancer directed therapy, and whose primary hematologist is planning to initiate a conversation regarding transition to hospice will be eligible for enrollment. Transfusion support: Patients will be offered symptom-driven transfusion support in addition to standard hospice care |
| 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 | Proportion of Eligible Patients Choosing to Participate in the Care Model Under Study Rather Than Standard of Care. | Measured as: the number of eligible patients approached and number who elect to enter the study and participate in the novel care model rather than through the traditional hospice care model. | Eligible patients approached for participation | Posted | Count of Participants | Participants | Through study completion, on average 2 years |
|
From the date of study enrollment until the date of death.
Information about adverse effects associated with blood transfusions were collected, only for participants in Arm A (Intervention Arm). Adverse events in the "Caregiver" arm were not 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 | Intervention Arm | Patients with aggressive hematologic malignancies who are hospice eligible, not pursuing further cancer directed therapy, and whose primary hematologist is planning to initiate a conversation regarding transition to hospice will be eligible for enrollment. Transfusion support: Patients will be offered symptom-driven transfusion support in addition to standard hospice care |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roxanne Wood | Brown University | 401-863-3000 | roxanne_wood@brown.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 | Sep 24, 2020 | Nov 24, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D009190 | Myelodysplastic Syndromes |
| D015470 | Leukemia, Myeloid, Acute |
| D008223 | Lymphoma |
| D007938 | Leukemia |
| D054219 | Neoplasms, Plasma Cell |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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single-center, prospective pilot study
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Count endpoint: Number of days subject spent in the ICU in the last 30 days of life
| Last 30 days of life. |
| Death in an Acute Care Hospital | Binary endpoint: met if subject passed away in an acute care hospital | From enrollment until death or withdrawal of consent, on average 2 months. |
| Receipt of Chemotherapy in the Last 14 Days of Life | Binary endpoint: met if subject received chemotherapy in the last 14 days of life | Last 14 days of life |
| BG001 | Caregivers | Caregivers of participants in Arm A |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Diagnosis | Only relevant to the Intervention Arm | Caregivers do not have a diagnosis, so 0 participants from that arm have been analyzed and they are not included in the total | Count of Participants | Participants |
|
|
|
| Secondary | Time Enrolled on Hospice. | Count endpoint: number of days enrolled on hospice | Posted | Median | Full Range | days | From enrollment until death or withdrawal of consent, on average 2 months. |
|
|
|
| Secondary | Number of Days in the ICU in the Last 30 Days of Life | Count endpoint: Number of days subject spent in the ICU in the last 30 days of life | Posted | Median | Full Range | days | Last 30 days of life. |
|
|
|
| Secondary | Death in an Acute Care Hospital | Binary endpoint: met if subject passed away in an acute care hospital | Posted | Count of Participants | Participants | From enrollment until death or withdrawal of consent, on average 2 months. |
|
|
|
| Secondary | Receipt of Chemotherapy in the Last 14 Days of Life | Binary endpoint: met if subject received chemotherapy in the last 14 days of life | Posted | Count of Participants | Participants | Last 14 days of life |
|
|
|
| 10 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
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| D001855 |
| Bone Marrow Diseases |
| D007951 | Leukemia, Myeloid |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|