Nurse AMIE (Addressing Malignancies in Individuals Everyday)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 344
- 试验地点
- 8
- 主要终点
- Survival
研究概览
简要总结
Nurse AMIE 3.0 is testing the effectiveness of an electronic symptom management system on overall survival in people with stage 3 and 4 cancer who live in rural areas.
详细描述
After being informed about the details of the study, including risks and potential benefits, participants who give their informed consent will do baseline measurements. After these measures are collected, participants will be randomly assigned to either receive the computer tablet Nurse AMIE program or a supportive care book. Participants will be asked to complete measurements throughout the course of their active participation, which will last for 2 years.
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
- Single (Outcomes Assessor)
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
- •Patient receiving care for their cancer
- •Age: 18+ years of age
- •Has stage 3 or 4 cancer, or an unstaged cancer that is considered 'advanced' (greater than stage 2) by their treating oncologist
- •Must be within six months of initiation of pharmacologic or radiation treatment, for curative or palliative purposes, from a medical or radiation oncologist
- •Clinician-rated ECOG function of 0-3
- •Lives in a county with RUCC code 4 - 9 and/or zip code with RUCA code 4-10
- •Has access to personal device capable of receiving telephone calls for study facilitator check-ins
- •Fluent in written and spoken English
- •Sufficient vision/hearing to interact with the tablet and study staff
- •Clinician-defined life expectancy of 6 months or more
排除标准
- •Patients with medical or psychiatric conditions documented in the medical record (beyond cancer, its treatments, and its symptoms) that would impair our ability to test study hypotheses (e.g. psychotic disorders, dementia, inability to give informed consent, or follow study instructions).
- •Patients who are participating in any other supportive care or behavioral intervention studies.
- •Non-English speaking patients will be excluded, as they represent less than 2% of the population targeted.
研究组 & 干预措施
Nurse AMIE Supportive Care Intervention
Participants in the intervention arm will receive the computer tablet with the Nurse AMIE program. Nurse AMIE will assess their symptoms daily and provide an intervention to help manage their symptoms.
干预措施: Nurse AMIE (Behavioral)
Usual Care
Participants in the usual care arm will receive a book with some supportive care educational materials and recommendations.
干预措施: Usual Care (Behavioral)
结局指标
主要结局
Survival
时间窗: through study completion, an average of two years
Survival of each participant will be monitored through the electronic medical records throughout the course of the study. After the study is completed, we will monitor survival using the National Death Index from the Centers for Disease Control and Prevention (CDC).
次要结局
- Change in Physical Function measured using the Short Physical Performance Battery (SPPB)(baseline, month 6, month 12, month 18, month 24)
- Cost-Effectiveness measured using a self-report survey of Healthcare Utilization(month 24)
- Change in Symptoms measured using the Patient-Reported Outcomes Measurement Information System: The PROMIS ®-Preference (PROPr)(baseline, month 1, month 3, month 6, month 9, month 12, month 18, month 24)
- Change in Health-Related Quality of Life measured using the 36-Item Short Form Health Survey (SF-36)(baseline, month 6, month 12, month 18, month 24)
- Cost-Effectiveness measured using a self-report survey of Healthcare Utilization(baseline)
- Cost-Effectiveness measured using a self-report survey of Healthcare Utilization(month1)
- Cost-Effectiveness measured using a self-report survey of Healthcare Utilization(month 3)
- Cost-Effectiveness measured using a self-report survey of Healthcare Utilization(month 6)
- Cost-Effectiveness measured using a self-report survey of Healthcare Utilization(month 9)
- Cost-Effectiveness measured using a self-report survey of Healthcare Utilization(month 12)
- Cost-Effectiveness measured using a self-report survey of Healthcare Utilization(month 18)
研究者
Kathryn Schmitz
Professor
University of Pittsburgh