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

Myelodysplastic Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04482894
• Other study ID #: HSR 200133
• Status: Recruiting
• Phase: Phase 2
• Start date: August 19, 2020
• Est. completion date: April 1, 2025

Study information

• Verified date: May 2023
• Source: University of Virginia
• Contact: Emily Leytham
• Phone: (434) 924-7621
• Email: EL5MF[@]hscmail.mcc.virginia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: April 1, 2025
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• ALL, Adult
• AML, Adult
• Leukemia
• Leukemia, Acute
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Other:
• Palliative Care Visits
Regular visits with a palliative (supportive) care specialist

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall survival	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.
Secondary	Duration of hospitalizations	Duration of hospitalizations	From enrollment through participant death or study completion, an average of 2 years.
Secondary	Type(s) of hospitalizations	Type(s) of hospitalizations	From enrollment through participant death or study completion, an average of 2 years.
Secondary	Frequency of hospitalizations	Frequency of hospitalizations	From enrollment through participant death or study completion, an average of 2 years.
Secondary	Emergency department visits	Frequency/Number of emergency department visits	From enrollment through participant death or study completion, an average of 2 years.
Secondary	Hospice services use	Dates of use of hospice services	From enrollment through participant death or study completion, an average of 2 years.
Secondary	Transfusions	Frequency/number and types of transfusions received	From enrollment through participant death or study completion, an average of 2 years.
Secondary	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	At time of enrollment, and then once a month during participation through participant death or study completion, an average of 2 years.
Secondary	Code status change	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.
Secondary	Goals of Care (GOC) Discussions	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.