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

NCT ID: NCT04482894

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-19
• Study Completion Date: 2026-04-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Palliative Care Intervention

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.

Group Type: EXPERIMENTAL

Palliative Care Visits

Intervention Type: OTHER

Regular visits with a palliative (supportive) care specialist

Standard Clinical Care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Palliative Care Visits

Regular visits with a palliative (supportive) care specialist

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Karen Ballen, MD

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karen Ballen, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

University of Virginia

Charlottesville, Virginia, United States

Countries

United States

Other Identifiers

HSR 200133

Identifier Type: -

Identifier Source: org_study_id