Trial Outcomes & Findings for Removing Transfusion Dependence as a Barrier to Hospice Enrollment (NCT NCT05063591)

Last Updated: 2026-01-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

18 participants

Primary outcome timeframe

Through study completion, on average 2 years

Results posted on

2026-01-15

Participant Flow

Of 22 patients and 9 caregivers screened, 10 patients (45%) and 8 caregivers enrolled. 4 screened patients died before consenting.

Participant milestones

Participant milestones
Measure	Caregivers Patient caregivers	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
Overall Study STARTED	8	10
Overall Study COMPLETED	8	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Caregivers do not have a diagnosis, so 0 participants from that arm have been analyzed and they are not included in the total

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Arm n=10 Participants 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	Caregivers n=8 Participants Caregivers of participants in Arm A	Total n=18 Participants Total of all reporting groups
Age, Continuous	80 years n=10 Participants	60 years n=8 Participants	77.5 years n=18 Participants
Sex: Female, Male Female	4 Participants n=10 Participants	8 Participants n=8 Participants	12 Participants n=18 Participants
Sex: Female, Male Male	6 Participants n=10 Participants	0 Participants n=8 Participants	6 Participants n=18 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=10 Participants	0 Participants n=8 Participants	0 Participants n=18 Participants
Race (NIH/OMB) Asian	0 Participants n=10 Participants	0 Participants n=8 Participants	0 Participants n=18 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=10 Participants	0 Participants n=8 Participants	0 Participants n=18 Participants
Race (NIH/OMB) Black or African American	0 Participants n=10 Participants	0 Participants n=8 Participants	0 Participants n=18 Participants
Race (NIH/OMB) White	10 Participants n=10 Participants	7 Participants n=8 Participants	17 Participants n=18 Participants
Race (NIH/OMB) More than one race	0 Participants n=10 Participants	0 Participants n=8 Participants	0 Participants n=18 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants	1 Participants n=8 Participants	1 Participants n=18 Participants
Diagnosis Acute myeloid leukemia	6 Participants n=10 Participants • Caregivers do not have a diagnosis, so 0 participants from that arm have been analyzed and they are not included in the total	0 Participants Caregivers do not have a diagnosis, so 0 participants from that arm have been analyzed and they are not included in the total	6 Participants n=10 Participants • Caregivers do not have a diagnosis, so 0 participants from that arm have been analyzed and they are not included in the total
Diagnosis Other	4 Participants n=10 Participants • Caregivers do not have a diagnosis, so 0 participants from that arm have been analyzed and they are not included in the total	0 Participants Caregivers do not have a diagnosis, so 0 participants from that arm have been analyzed and they are not included in the total	4 Participants n=10 Participants • Caregivers do not have a diagnosis, so 0 participants from that arm have been analyzed and they are not included in the total

PRIMARY outcome

Timeframe: Through study completion, on average 2 years

Population: Eligible patients approached for participation

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.

Outcome measures

Outcome measures
Measure	Intervention Arm n=22 Participants 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
Proportion of Eligible Patients Choosing to Participate in the Care Model Under Study Rather Than Standard of Care.	10 Participants

SECONDARY outcome

Timeframe: From enrollment until death or withdrawal of consent, on average 2 months.

Count endpoint: number of days enrolled on hospice

Outcome measures

Outcome measures
Measure	Intervention Arm n=10 Participants 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
Time Enrolled on Hospice.	13 days Interval 4.0 to 103.0

SECONDARY outcome

Timeframe: Last 30 days of life.

Count endpoint: Number of days subject spent in the ICU in the last 30 days of life

Outcome measures

Outcome measures
Measure	Intervention Arm n=10 Participants 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
Number of Days in the ICU in the Last 30 Days of Life	0 days Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: From enrollment until death or withdrawal of consent, on average 2 months.

Binary endpoint: met if subject passed away in an acute care hospital

Outcome measures

Outcome measures
Measure	Intervention Arm n=10 Participants 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
Death in an Acute Care Hospital	0 Participants

SECONDARY outcome

Timeframe: Last 14 days of life

Binary endpoint: met if subject received chemotherapy in the last 14 days of life

Outcome measures

Outcome measures
Measure	Intervention Arm n=10 Participants 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
Receipt of Chemotherapy in the Last 14 Days of Life	0 Participants

Adverse Events

Intervention Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 10 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Roxanne Wood

Brown University

Phone: 401-863-3000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place