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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Palliative Care Intervention | Experimental | 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. |
|
| Standard Clinical Care | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palliative Care Visits | Other | Regular visits with a palliative (supportive) care specialist |
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| 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 |
| 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 |
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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)
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| Name | Affiliation | Role |
|---|---|---|
| Karen Ballen, MD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia | Charlottesville | Virginia | 22903 | United States |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| D015470 | Leukemia, Myeloid, Acute |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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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. |
| D007951 | Leukemia, Myeloid |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001855 | Bone Marrow Diseases |