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Removing Transfusion Dependence as a Barrier to Hospice Enrollment (BRUOG-407)

Primary Purpose

Hematologic Malignancy, Myelodysplastic Syndromes, Acute Myeloid Leukemia

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transfusion support
Sponsored by
Adam Olszewski
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hematologic Malignancy focused on measuring palliative care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rhode Island Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention arm

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time enrolled on hospice.
Count endpoint: number of days enrolled on hospice
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
Death in an acute care hospital
Binary endpoint: met if subject passed away in an acute care hospital
Receipt of chemotherapy in the last 14 days of life
Binary endpoint: met if subject received chemotherapy in the last 14 days of life

Full Information

First Posted
September 11, 2021
Last Updated
February 6, 2023
Sponsor
Adam Olszewski
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1. Study Identification

Unique Protocol Identification Number
NCT05063591
Brief Title
Removing Transfusion Dependence as a Barrier to Hospice Enrollment
Acronym
BRUOG-407
Official Title
Removing Transfusion Dependence as a Barrier to Hospice Enrollment
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 9, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Adam Olszewski

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Malignancy, Myelodysplastic Syndromes, Acute Myeloid Leukemia, Lymphoma, Leukemia, Myeloma
Keywords
palliative care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
single-center, prospective pilot study
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Transfusion support
Intervention Description
Patients will be offered symptom-driven transfusion support in addition to standard hospice care
Primary Outcome Measure Information:
Title
Proportion of eligible patients choosing to participate in the care model under study rather than standard of care.
Description
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.
Time Frame
Through study completion, on average 2 years
Secondary Outcome Measure Information:
Title
Time enrolled on hospice.
Description
Count endpoint: number of days enrolled on hospice
Time Frame
From enrollment until death or withdrawal of consent, on average 2 months.
Title
Number of days in the ICU in the last 30 days of life
Description
Count endpoint: Number of days subject spent in the ICU in the last 30 days of life
Time Frame
From enrollment until death or withdrawal of consent, on average 2 months.
Title
Death in an acute care hospital
Description
Binary endpoint: met if subject passed away in an acute care hospital
Time Frame
From enrollment until death or withdrawal of consent, on average 2 months.
Title
Receipt of chemotherapy in the last 14 days of life
Description
Binary endpoint: met if subject received chemotherapy in the last 14 days of life
Time Frame
From enrollment until death or withdrawal of consent, on average 2 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela C Egan, MD
Organizational Affiliation
Rhode Island Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.lifespan.org/centers-services/cancer-research-and-clinical-trials
Description
Cancer Research and Clinical Trials at Lifespan Cancer Institute

Learn more about this trial

Removing Transfusion Dependence as a Barrier to Hospice Enrollment

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