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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Other: Palliative Care Visits


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Palliative Care Intervention<br>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<br>* Regular visits with a palliative (supportive) care specialist<br>|
| No Intervention: Standard Clinical Care<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| Duration of hospitalizations | Duration of hospitalizations | From enrollment through participant death or study completion, an average of 2 years. | 
| Type(s) of hospitalizations | Type(s) of hospitalizations | From enrollment through participant death or study completion, an average of 2 years. | 
| Frequency of hospitalizations | Frequency of hospitalizations | From enrollment through participant death or study completion, an average of 2 years. | 
| Emergency department visits | Frequency/Number of emergency department visits | From enrollment through participant death or study completion, an average of 2 years. | 
| Hospice services use | Dates of use of hospice services | From enrollment through participant death or study completion, an average of 2 years. | 
| Transfusions | Frequency/number and types of transfusions received | From enrollment through participant death or study completion, an average of 2 years. | 
| 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. | 
| 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. | 
| 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. |