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

Primary Purpose

Leukemia, Acute, AML, Adult, ALL, Adult

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Palliative Care Visits
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Leukemia, Acute

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • University of VirginiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Palliative Care Intervention

Standard Clinical Care

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall survival
Time from enrollment through death (for participants that die)
Duration of hospitalizations
Duration of hospitalizations
Type(s) of hospitalizations
Type(s) of hospitalizations
Frequency of hospitalizations
Frequency of hospitalizations
Emergency department visits
Frequency/Number of emergency department visits
Hospice services use
Dates of use of hospice services
Transfusions
Frequency/number and types of transfusions received
Quality of life measure
Quality of life based on FACT-Leukemia questionnaire, scored from 0 to 176, with a higher score indicating better quality of life
Code status change
Dates and types of changes to code status (e.g. Do not rescuscitate (DNR) with details)
Goals of Care (GOC) Discussions
Whether a GOC discussion occurs while on study, and if so, date and location of discussion

Full Information

First Posted
July 8, 2020
Last Updated
May 8, 2023
Sponsor
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT04482894
Brief Title
Palliative Care Oncology in Patients With Relapsed, Refractory, and High-Risk Leukemias or MDS
Official Title
Palliative Care Oncology in Patients With Relapsed, Refractory, and High-Risk Leukemias or High-Risk Myelodysplastic Syndrome: Randomized Phase II Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 19, 2020 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
April 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Acute, AML, Adult, ALL, Adult, Myelodysplastic Syndromes

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Palliative Care Intervention
Arm Type
Experimental
Arm 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.
Arm Title
Standard Clinical Care
Arm Type
No Intervention
Arm 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.
Intervention Type
Other
Intervention Name(s)
Palliative Care Visits
Intervention Description
Regular visits with a palliative (supportive) care specialist
Primary Outcome Measure Information:
Title
Place of death
Description
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 Outcome Measure Information:
Title
Overall survival
Description
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.
Title
Duration of hospitalizations
Description
Duration of hospitalizations
Time Frame
From enrollment through participant death or study completion, an average of 2 years.
Title
Type(s) of hospitalizations
Description
Type(s) of hospitalizations
Time Frame
From enrollment through participant death or study completion, an average of 2 years.
Title
Frequency of hospitalizations
Description
Frequency of hospitalizations
Time Frame
From enrollment through participant death or study completion, an average of 2 years.
Title
Emergency department visits
Description
Frequency/Number of emergency department visits
Time Frame
From enrollment through participant death or study completion, an average of 2 years.
Title
Hospice services use
Description
Dates of use of hospice services
Time Frame
From enrollment through participant death or study completion, an average of 2 years.
Title
Transfusions
Description
Frequency/number and types of transfusions received
Time Frame
From enrollment through participant death or study completion, an average of 2 years.
Title
Quality of life measure
Description
Quality of life based on FACT-Leukemia questionnaire, scored from 0 to 176, with a higher score indicating better quality of life
Time Frame
At time of enrollment, and then once a month during participation through participant death or study completion, an average of 2 years.
Title
Code status change
Description
Dates and types of changes to code status (e.g. Do not rescuscitate (DNR) with details)
Time Frame
From enrollment through participant death or study completion, an average of 2 years.
Title
Goals of Care (GOC) Discussions
Description
Whether a GOC discussion occurs while on study, and if so, date and location of discussion
Time Frame
From enrollment through participant death or study completion, an average of 2 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. OR Patients with relapsed AML, ALL, high risk MDS or high risk CMML, ages 18 and older. OR 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Leytham
Phone
(434) 924-7621
Email
EL5MF@hscmail.mcc.virginia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Morgan van Ornum
Phone
(434) 297-4579
Email
NQK9GS@hscmail.mcc.virginia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Firas El Chaer, MD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Leytham
Phone
434-924-7621
Email
EL5MF@hscmail.mcc.virginia.edu
First Name & Middle Initial & Last Name & Degree
Emily Hoade
Phone
(434) 243-3983
Email
ESH5RQ@hscmail.mcc.virginia.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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