A Decisional Intervention for Older Adults With Acute Myeloid Leukemia and Their Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,020
- 试验地点
- 7
- 主要终点
- Distress Thermometer Questionnaire at 1 month
研究概览
简要总结
This is a multicenter randomized controlled trial that assesses the efficacy of a decisional intervention [University of Rochester-Geriatric Oncology assessment for Acute myeloid Leukemia (UR-GOAL)] compared to an attention control.
详细描述
This is a multicenter randomized controlled trial with four sites that assesses the efficacy of a decisional intervention [University of Rochester-Geriatric Oncology assessment for Acute myeloid Leukemia (UR-GOAL)] compared to an attention control. Subjects will be randomized 1:1 to either the intervention arm or the attention control arm. Compared to an attention control, UR-GOAL will improve patient distress, observed and patient-perceived shared decision making (SDM), and patient decisional conflict.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria:
- •Age ≥60 years (from date of consent, confirmed on electronic medical records)
- •A new diagnosis of AML
- •Diagnosis can be based on the International Consensus Classification or World Health Organization
- •Myeloid sarcoma is allowed
- •AML with central nervous system involvement is allowed
- •Cancer-directed treatment has not started
- •Treatment to temporarily decrease white blood cells is acceptable; these may include hydroxyurea, leukapheresis, or cytarabine
- •Intrathecal chemotherapy is acceptable
- •The patient's oncologist has been or will be enrolled on the study
- •English or Spanish-speaking
- •Patients without a caregiver will still be eligible to participate in the study
排除标准
- •A diagnosis of acute promyelocytic leukemia
- •Patients with psychiatric or cognitive conditions which the treating oncologist believes prohibits informed consent or compliance with study procedures
- •Prior cancer-directed treatment for AML
- •Inclusion criteria:
- •Selected by the patient when asked if there is a "family member, partner, friend or caregiver [age 18 or older] with whom you discuss or who can be helpful in healthrelated matters."
- •Caregiver may be paid/professional or informal caregiver
- •Able to provide informed consent
- •English or Spanish-speaking
- •Oncologists
- •Inclusion criteria:
- •Oncologists caring for patients with AML Exclusion criteria
研究组 & 干预措施
Attention Control Arm
Patients will view a nutritional video, complete a nutrition questionnaire, and will be provided with a nutrition handout and asked to review and discuss at upcoming clinical visits. Caregivers, if available, will view the nutritional video, and will be provided with a nutrition handout and asked to review and discuss at upcoming clinical visits. Oncologists will be provided with the patient's completed nutrition questionnaire and asked to review and discuss at upcoming clinical visits.
UR-GOAL Intervention
Patients will view an AML video, complete the best-worst scaling, and be provided with a summary report consisting of their priorities; they will will be asked to review and discuss at upcoming clinical visits. Caregivers, if available, will view the same AML video and be provided with the same summary report. Oncologists will be provided with a summary report consisting of the patient's geriatric assessment, priorities, and perception of prognosis; they will be asked to review and discuss at upcoming clinical visits.
干预措施: UR-GOAL (Behavioral)
结局指标
主要结局
Distress Thermometer Questionnaire at 1 month
时间窗: 1 month
A self-report measure to capture distress and identify a list of sources of that distress. This is a 10-item scale, rated from 0-10 (0=no distress, 10=severe distress), with a possible total of 10; a higher score indicates greater distress.
次要结局
- 9-item Shared Decision Making Questionnaire at 2 weeks(2 weeks)
- Decisional Conflict Scale Questionnaire at 2 weeks(2 weeks)
- Observed shared decision making(Day 0)
研究者
Kah Poh Loh
Associate Professor, Division of Hematology/Oncology, Department of Medicine
University of Rochester