Removing Transfusion Dependence as a Barrier to Hospice Enrollment

Lymphoma Clinical Trial

— BRUOG-407  

Official title:

Removing Transfusion Dependence as a Barrier to Hospice Enrollment

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05063591
• Other study ID #: BRUOG-407
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 9, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2023
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Hematologic Malignancy
• Hematologic Neoplasms
• Leukemia
• Lymphoma
• Myelodysplastic Syndromes
• Myeloma

Intervention

Other:
• Transfusion support
Patients will be offered symptom-driven transfusion support in addition to standard hospice care

Locations

Country	Name	City	State
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Adam Olszewski

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Through study completion, on average 2 years
Secondary	Time enrolled on hospice.	Count endpoint: number of days enrolled on hospice	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	From enrollment until death or withdrawal of consent, on average 2 months.
Secondary	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.
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	From enrollment until death or withdrawal of consent, on average 2 months.

External Links

•   Cancer Research and Clinical Trials at Lifespan Cancer Institute