SIGNAL:Identifying Behavioral Anomalies Using Smartphones to Improve Cancer Care
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Rate of completion
研究概览
简要总结
This research study is testing the use of a smartphone app to identify clinically meaningful changes in the behaviors of patients' with gynecological cancers by using passively collected smartphone data.
详细描述
This is a pilot study of patients with advanced gynecologic cancers and oncology providers from the Dana-Farber Cancer Institute's Gynecologic Oncology Program to explore the feasibility and acceptability of a smartphone-based real-time behavioral anomaly detection system (SIGNAL).
The research study procedures include screening for eligibility and study interventions including smartphone data collection, surveys, and a brief interview once you have completed the study to learn more about your experiences on the study.
Participants will download the adapted Beiwe app for a 6-month period and the investigators will collect passive smartphone sensor data and active PRO data bi-weekly.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Women >18 years of age with newly diagnosed ovarian cancer (i.e. prior to completion of cytoreductive surgery-whether primary or interval cytoreductive surgery).
- •Own a smartphone (Android or iOS).
- •Capable of downloading and running the study apps.
- •Can read and provide informed consent in English.
- •Do not have cognitive or visual impairments that would preclude use of the app.
- •Exclusion Criteria
- •Patients will be ineligible if they are participating in an investigational drug treatment trial that requires structured symptom or toxicity reporting at the time of enrollment.
- •Patients with severe cognitive impairments or who appear too weak, emotionally distraught, agitated or ill to participate, as judged by either the research study staff or an oncology provider, will be excluded.
- •Patients who are unable to provide informed consent in English will be excluded because the smartphone app is only available in English at this time.
- •Children and young adults up to age 17 will be excluded because the diagnosis of metastatic gynecologic cancers in this age group is rare and the proposed instruments are not designed for people of those ages.
排除标准
- 未提供
结局指标
主要结局
Rate of completion
时间窗: 6 Months
Feasibility will be demonstrated if ≥50% of eligible participants adhere to the smartphone app
Burden rate
时间窗: 6 Months
Acceptability will be defined as: \<30% of patients rate the study as burdensome.
Rate of enrollment
时间窗: 6 Months
Feasibility will be demonstrated if ≥50% of eligible participants enroll
次要结局
未报告次要终点
研究者
Alexi A. Wright
Principal Investigator
Dana-Farber Cancer Institute