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

N/AActive Not RecruitingNCT04482894

University of Virginia105 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

105

Conditions

Leukemia, Acute AML, Adult ALL, Adult Myelodysplastic Syndromes

Interventions

Palliative Care VisitsOTHER

Regular visits with a palliative (supportive) care specialist

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

University of Virginia

Charlottesville, Virginia, United States

Outcomes

Primary Outcomes

Place of death

Location of death (ICU, inpatient floor, hospice, home)

Time frame: At the time of death (for participants that die), assessed from enrollment through study completion, an average of 2 years

Secondary Outcomes

Overall survival

Time from enrollment through death (for participants that die)

Time frame: From enrollment through participant death or end of study from enrollment through participant death or study completion, an average of 2 years.

Duration of hospitalizations