The Feasibility of Telehealth-Based Palliative Care Intervention and Digital Symptom Monitoring on Patients With AML Receiving Low-Intensity Induction Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Rate of usage of digital symptom monitoring application, Noona
研究概览
简要总结
AML is the most common leukemia diagnosed in adults. In spite of recent low-intensity therapies that have improved outcomes for older AML patients, AML remains associated with poor prognosis as well as high symptom burden. While the benefits of early palliative care as well as electronic PROs have been well-described in the oncology population, neither have been well-studied in the AML population, and have never been studied in combination. We propose a prospective, single-center, single-arm trial to evaluate the feasibility of a virtually-mediated supportive care model utilizing both electronic PROs and palliative care for patients with AML being treated with low-intensity therapy.
AIM1: is to evaluate and describe the feasibility of implementing early specialty palliative care referrals carried out via telehealth/video-based modalities in combination with digital symptom monitoring for patients recently diagnosed with acute myeloid leukemia (AML) and starting low intensity induction therapy.
AIM2: study the differences in health-related quality-of-life (HRQoL) metrics using patient-reported outcomes (PROs) in patients recently diagnosed with AML and starting low intensity induction therapy who receive early referral to telehealth/video-based palliative care visits compared to standard care.
AIM3: to explore the patient experience of patients with AML on low-intensity therapy, capture rates of advance care planning, hospice utilization, and hospital utilization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients being treated for a diagnosis of acute myeloid leukemia at Stanford Cancer Center
- •Patients determined to be candidates for low intensity induction therapy (not requiring hospitalization to administer treatment) by their leukemia physician
- •Estimated life expectancy of 6 months
- •Functional status at the level of at least being capable of limited self-care, confined to chair or bed for half the day or better
- •Access to smartphone, tablet, or computer with capability to utilize a symptom tracking application
排除标准
- •Relapsed or refractory AML
- •Patients who have established care with palliative care previously
- •Non-English-speaking, as the Noona application is developed in the English language
研究组 & 干预措施
All patients
All patients enrolled in this trial will be referred to palliative care for planned monthly virtual visits, be instructed on the use of a digital application Noona that can be downloaded on their personal electronic device, and will be prompted to fill out symptom questionnaires using Noona prior to palliative care visits (required) as well as weekly (optional).
干预措施: Palliative Care + Digital Symptom Monitoring (Other)
结局指标
主要结局
Rate of usage of digital symptom monitoring application, Noona
时间窗: Through study completion, an average of 6 months
This will be measured by the percentage of patients who complete at least 50% of Noona surveys associated with their palliative care visits
Rate of completed palliative care referrals and monthly visits
时间窗: Through study completion, an average of 6 months
This will be measured as a percentage of patients who overall complete the initial palliative care referral and at least 50% of their scheduled monthly visits
次要结局
- Mean change in Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) scores(Baseline, 3 months, and 6 months)
- Mean change in Hospital Anxiety and Depression Scale (HADS) scores(Baseline, 3 months, and 6 months)
- Mean change in Satisfaction with Decision-Making Scale scores(Baseline, 3 months, and 6 months)
- Overall satisfaction with usage of Noona questionnaire(Baseline, 6 months)
- Mean change in Patient Health Questionnaire (PHQ)-9 scores(Baseline, 3 months, and 6 months)
研究者
Kavitha Ramchandran
Clinical Professor, Medicine - Oncology
Stanford University