Clinical trial NCT04482894: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Leukemia, Acute
AML, Adult
ALL, Adult
Myelodysplastic Syndromes
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2020-07-23
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Place of death
timeFrame: At the time of death (for participants that die), assessed from enrollment through study completion, an average of 2 years
Secondary outcomes:
measure: Overall survival
timeFrame: From enrollment through participant death or end of study from enrollment through participant death or study completion, an average of 2 years.
measure: Duration of hospitalizations
timeFrame: From enrollment through participant death or study completion, an average of 2 years.
measure: Type(s) of hospitalizations
timeFrame: From enrollment through participant death or study completion, an average of 2 years.
measure: Frequency of hospitalizations
timeFrame: From enrollment through participant death or study completion, an average of 2 years.
measure: Emergency department visits
timeFrame: From enrollment through participant death or study completion, an average of 2 years.
measure: Hospice services use
timeFrame: From enrollment through participant death or study completion, an average of 2 years.
measure: Transfusions
timeFrame: From enrollment through participant death or study completion, an average of 2 years.
measure: Quality of life measure
timeFrame: At time of enrollment, and then once a month during participation through participant death or study completion, an average of 2 years.
measure: Code status change
timeFrame: From enrollment through participant death or study completion, an average of 2 years.
measure: Goals of Care (GOC) Discussions
timeFrame: From enrollment through participant death or study completion, an average of 2 years.
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Karen Ballen, MD
role: PRINCIPAL_INVESTIGATOR
References: