Clinical trial NCT05063591: Removing Transfusion Dependence as a Barrier to Hospice Enrollment
Official title: Removing Transfusion Dependence as a Barrier to Hospice Enrollment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hematologic Malignancy
Myelodysplastic Syndromes
Acute Myeloid Leukemia
Lymphoma
Leukemia
Myeloma
Keywords: palliative care
Lead sponsor: Brown University
Sponsor class: OTHER
First posted: 2021-10-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single-center, prospective pilot study
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Aged 18 and older
* Advanced hematologic malignancies
* Hospice eligible as determined by their primary hematologist
* Have opted to forego further cancer-directed therapy.
* Transfusion Dependent: Requiring at least 2 units of blood products

Exclusion Criteria:

* Patients with major psychiatric illness
* Patients without the ability to speak and read English

Primary outcomes:
measure: Proportion of eligible patients choosing to participate in the care model under study rather than standard of care.
timeFrame: Through study completion, on average 2 years
Secondary outcomes:
measure: Time enrolled on hospice.
timeFrame: From enrollment until death or withdrawal of consent, on average 2 months.
measure: Number of days in the ICU in the last 30 days of life
timeFrame: From enrollment until death or withdrawal of consent, on average 2 months.
measure: Death in an acute care hospital
timeFrame: From enrollment until death or withdrawal of consent, on average 2 months.
measure: Receipt of chemotherapy in the last 14 days of life
timeFrame: From enrollment until death or withdrawal of consent, on average 2 months.
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Pamela C Egan, MD
role: PRINCIPAL_INVESTIGATOR
References: