Pilot Randomized Controlled Trial of a Remote Monitoring and Symptom Management Intervention (ASSIST) Among Patients Receiving Systemic Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Recruitment Rates
研究概览
简要总结
The goal of this clinical trial is to learn if an artificial intelligence phone application called ASSIST can help patients receiving cancer treatment.
The main question[s] it aims to answer are:
Is ASSIST feasible for patients (meaning can it be used by patients)? Is ASSIST acceptable to patients (meaning do patients like it)?
Researchers will compare the ASSIST phone application to see how it compares to usual clinical care.
Participants on the ASSIST arm will use the ASSIST phone application for 12 weeks, and participants in both groups will complete surveys.
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
- •Age 18 years or older
- •Ability to understand English
- •About to begin definitive systemic treatment (or within 4 weeks of beginning treatment) based upon the oncology treatment intent form for a new diagnosis of breast cancer, colorectal cancer, or lymphoma.
- •Expected treatment duration of at least 12 weeks
- •Own or willing to receive a smartphone
排除标准
- •Cognitive impairment that would interfere with ability to use smartphone application (as assessed by their attending physician)
- •Visual or motor impairment that would prevent smartphone use
- •Expected survival less than 3 months
研究组 & 干预措施
ASSIST phone application arm
The intervention consists of a smartphone-based application that provides personalized support using AI during cancer treatment. Patients will also receive standard care from their oncology team, including routine symptom management and supportive care measures.
干预措施: ASSIST phone application (Other)
Usual Care
Patients in the usual care group will receive standard care from their oncology team, including routine symptom management and supportive care measures.
结局指标
主要结局
Recruitment Rates
时间窗: From enrollment to end of intervention at 12 weeks
We will deem the intervention feasible if recruitment rates achieve ≥ 60% of eligible patients
Percentage of participants using the digital application once per week in at least 7/12 weeks
时间窗: From enrollment to end of intervention at 12 weeks
The intervention will be feasible if among those enrolled and randomized to the intervention arm, ≥ 60% use ASSIST once per week in at least 7/12 weeks.
次要结局
- Acceptability(From enrollment to the end of the intervention at 12 weeks)
研究者
Patrick C. Johnson, MD
Assistant Professor of Medicine
Massachusetts General Hospital