Palliative Care Oncology in Patients With Relapsed, Refractory, and High-Risk Leukemias or High-Risk Myelodysplastic Syndrome: Randomized Phase II Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Place of death
研究概览
简要总结
The purpose of this study is to estimate the potential benefit of early and continued palliative care (PC) consultation on end of life issues.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •1. Participants must not have a diagnosis of Acute Promyelocytic Leukemia (APL)
研究组 & 干预措施
Palliative Care Intervention
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.
干预措施: Palliative Care Visits (Other)
Standard Clinical Care
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.
结局指标
主要结局
Place of death
时间窗: 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)
次要结局
- 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.)
研究者
Karen Ballen, MD
Professor of Medicine
University of Virginia