Palliative Care Oncology in Patients With Relapsed, Refractory, and High-Risk Leukemias or MDS

Phase 2

Active, not recruiting

• Conditions: Leukemia, Acute; AML, Adult; Myelodysplastic Syndromes; ALL, Adult

• Registration Number: NCT04482894
• Lead Sponsor: University of Virginia

Brief Summary

The purpose of this study is to estimate the potential benefit of early and continued palliative care (PC) consultation on end of life issues.

Detailed Description

Participants in this study will be randomized to either an intervention group or a standard of care group. Participants in the intervention group will participate in regular visits with a palliative (or supportive) care specialist, while participants in the standard of care group will only see palliative care specialists if the clinician requests a referral. All participants will be asked to complete monthly questionnaires regarding their general well-being.

Participants have a greater chance of being assigned to the intervention group than to the standard of care group. On average, in every 5 people randomized, 3 will be randomized to the intervention and 2 will be randomized to standard of care.

Study Timeline

• Study First Submitted: 2020-07-08
• Study First Submitted QC: 2020-07-19
• Study First Posted: 2020-07-23
• Study Start: 2020-08-19
• Status Verified: 2025-05
• Primary Completion: 2025-05-09
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

1. Ability to provide informed consent

2. Stated willingness to comply with all study procedures and availability for the duration of the study

3. Any of the following:

   1. Patients with a new diagnosis of AML, ALL, high risk myelodysplastic syndrome (MDS), or high risk chronic myelomonocytic leukemia (CMML) who are age 65 and older.

      OR

   2. Patients with relapsed AML, ALL, high risk MDS or high risk CMML, ages 18 and older.

      OR

   3. Patients with refractory AML, ALL, high risk MDS or high risk CMML, ages 18 and older.

Refractory AML/ALL will be defined as persistent leukemia despite two or more cycles of induction chemotherapy.

Refractory MDS will be defined according to the 2006 IWG response criteria Refractory CMML will be based on the assessment of the treating investigator.

Exclusion Criteria

1. Participants must not have a diagnosis of Acute Promyelocytic Leukemia (APL)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Place of death	At the time of death (for participants that die), assessed from enrollment through study completion, an average of 2 years	Location of death (ICU, inpatient floor, hospice, home)

Secondary Outcome Measures

Name	Time	Method
Hospice services use	From enrollment through participant death or study completion, an average of 2 years.	Dates of use of hospice services
Goals of Care (GOC) Discussions	From enrollment through participant death or study completion, an average of 2 years.	Whether a GOC discussion occurs while on study, and if so, date and location of discussion
Frequency of hospitalizations	From enrollment through participant death or study completion, an average of 2 years.	Frequency of hospitalizations
Emergency department visits	From enrollment through participant death or study completion, an average of 2 years.	Frequency/Number of emergency department visits
Overall survival	From enrollment through participant death or end of study from enrollment through participant death or study completion, an average of 2 years.	Time from enrollment through death (for participants that die)
Duration of hospitalizations	From enrollment through participant death or study completion, an average of 2 years.	Duration of hospitalizations
Transfusions	From enrollment through participant death or study completion, an average of 2 years.	Frequency/number and types of transfusions received
Code status change	From enrollment through participant death or study completion, an average of 2 years.	Dates and types of changes to code status (e.g. Do not rescuscitate (DNR) with details)
Type(s) of hospitalizations	From enrollment through participant death or study completion, an average of 2 years.	Type(s) of hospitalizations
Quality of life measure	At time of enrollment, and then once a month during participation through participant death or study completion, an average of 2 years.	Quality of life based on FACT-Leukemia questionnaire, scored from 0 to 176, with a higher score indicating better quality of life

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States