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

University of Virginia

Status and phase: Active, not recruiting; Phase 2

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

Treatments: Other: Palliative Care Visits

Study type: Interventional

Funder types: Other

Identifiers

NCT04482894

HSR 200133

Details and patient eligibility

About

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

Full 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.

Enrollment: 105 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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105 participants in 2 patient groups

Palliative Care Intervention

Experimental group

Description:

Participants on this arm will see a palliative care specialist twice a week while they are in the hospital and about every other week when they are out of the hospital. If participants see their oncologist less often than every other week while they're out of the hospital, then visits with the palliative care specialist would be timed to occur on the same day as the oncologist visit. Participants will complete a questionnaire about once a month.

Treatment:

Other: Palliative Care Visits

Standard Clinical Care

No Intervention group

Description:

Participants will see a palliative care specialist only if they have a referral from their oncologist according to standard clinical care. Participants on this arm will not be discouraged from requesting a consult.