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

May 8, 2023 updated by: Firas El Chaer, MD, University of Virginia

Palliative Care Oncology in Patients With Relapsed, Refractory, and High-Risk Leukemias or High-Risk Myelodysplastic Syndrome: Randomized Phase II Study

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

105

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Palliative Care Visits
Regular visits with a palliative (supportive) care specialist
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 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)
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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: From enrollment through participant death or study completion, an average of 2 years.
Frequency/Number of emergency department visits
From enrollment through participant death or study completion, an average of 2 years.
Hospice services use
Time Frame: From enrollment through participant death or study completion, an average of 2 years.
Dates of use of hospice services
From enrollment through participant death or study completion, an average of 2 years.
Transfusions
Time Frame: From enrollment through participant death or study completion, an average of 2 years.
Frequency/number and types of transfusions received
From enrollment through participant death or study completion, an average of 2 years.
Quality of life measure
Time Frame: 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
At time of enrollment, and then once a month during participation through participant death or study completion, an average of 2 years.
Code status change
Time Frame: 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)
From enrollment through participant death or study completion, an average of 2 years.
Goals of Care (GOC) Discussions
Time Frame: 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
From enrollment through participant death or study completion, an average of 2 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Investigators

  • Principal Investigator: Firas El Chaer, MD, University of Virginia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 19, 2020

Primary Completion (Anticipated)

September 1, 2024

Study Completion (Anticipated)

April 1, 2025

Study Registration Dates

First Submitted

July 8, 2020

First Submitted That Met QC Criteria

July 19, 2020

First Posted (Actual)

July 23, 2020

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSR 200133

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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