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

NCT04482894 | Active Not Recruiting DMC

• 1 other identifier: HSR 200133
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Place of death

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

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

Secondary Outcomes (10)

• Overall survival

  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

  From enrollment through participant death or study completion, an average of 2 years.

• Type(s) of hospitalizations

  From enrollment through participant death or study completion, an average of 2 years.

• Frequency of hospitalizations

  From enrollment through participant death or study completion, an average of 2 years.

• Emergency department visits

  From enrollment through participant death or study completion, an average of 2 years.

Study Arms (2)

Palliative Care Intervention

EXPERIMENTAL

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.

Other: Palliative Care Visits

Standard Clinical Care

NO INTERVENTION

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.

Interventions

Palliative Care Visits OTHER

Regular visits with a palliative (supportive) care specialist

Palliative Care Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to provide informed consent
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Any of the following:
• 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.
• Patients with relapsed AML, ALL, high risk MDS or high risk CMML, ages 18 and older.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Leukemia; Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Bone Marrow Diseases

Study Officials

• Karen Ballen, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: July 23, 2020
• Study Start: August 19, 2020
• Primary Completion (Estimated): May 9, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)