Palliative Care Oncology in Patients With Relapsed, Refractory, and High-Risk Leukemias or High-Risk Myelodysplastic Syndrome: Randomized Phase II Study
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Leukemia, Acute
- Sponsor
- University of Virginia
- Enrollment
- 105
- Locations
- 1
- Primary Endpoint
- Place of death
- Status
- Active, Not Recruiting
- Last Updated
- 11 months ago
Overview
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.
Investigators
Karen Ballen, MD
Professor of Medicine
University of Virginia
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.
- •Patients with relapsed AML, ALL, high risk MDS or high risk CMML, ages 18 and older.
- •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
- •Participants must not have a diagnosis of Acute Promyelocytic Leukemia (APL)
Outcomes
Primary Outcomes
Place of death
Time Frame: At the time of death (for participants that die), assessed from enrollment through study completion, an average of 2 years
Location of death (ICU, inpatient floor, hospice, home)
Secondary Outcomes
- Hospice services use(From enrollment through participant death or study completion, an average of 2 years.)
- Goals of Care (GOC) Discussions(From enrollment through participant death or study completion, an average of 2 years.)
- Frequency of hospitalizations(From enrollment through participant death or study completion, an average of 2 years.)
- Emergency department visits(From enrollment through participant death or study completion, an average of 2 years.)
- Overall survival(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(From enrollment through participant death or study completion, an average of 2 years.)
- Transfusions(From enrollment through participant death or study completion, an average of 2 years.)
- Code status change(From enrollment through participant death or study completion, an average of 2 years.)
- Type(s) of hospitalizations(From enrollment through participant death or study completion, an average of 2 years.)
- Quality of life measure(At time of enrollment, and then once a month during participation through participant death or study completion, an average of 2 years.)