Technology-based Symptom Monitoring Intervention for Locally Advanced Head and Neck Cancer Patients Initiating Chemoradiation: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Users' satisfaction
研究概览
简要总结
The goal of this observational study is to assess the satisfaction and usability of an interactive and patient-centered mobile application (app), Oleena™, designed to assist head and neck cancer patients undergoing chemoradiation in managing common and distressing symptoms in real-time, as well as to assess the satisfaction and usability of the related HCP web portal. Additional secondary usage and clinical endpoints that would be used to assess intervention efficacy in future trials will be collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •≥18 years old
- •Planned to initiate chemoradiation for locally advanced head and neck cancer at Moffitt Cancer Center
- •ECOG performance status ≤2
- •Able to speak and read US English or Spanish
- •Able to provide informed consent
- •Owns a smartphone with an iOS or Android operating systemcompatible with Oleena
- •Able to access the internet
- •Willing to use a mobile app for symptom management
排除标准
- •Documented or observable psychiatric or neurological disorders that would interfere with study participation (e.g., psychosis, active substance abuse).
- •A prior cancer diagnosis except for non-melanoma skin cancer.
- •Currently enrolled in an industry-sponsored clinical trial.
- •Pregnant women.
- •Patients undergoing RE-irradiation
- •Patients who meet the inclusion criteria may be excluded at Investigator's discretion
结局指标
主要结局
Users' satisfaction
时间窗: End of study - Day 90 +/-10 from first radiotherapy
Users' (participants and HCPs) level of satisfaction with the symptom management app, which will be assessed via a validated, 4-item scale, Acceptability of Intervention Measures (score range 0-20)
次要结局
- Feasibility of the technology enabled symptom management solution(Assessed up to 90 days)
- Usability of the technology enabled symptom management solution(Day 30 and Day 90 +/-10 from first radiotherapy)
- Appropriateness of the recommendations(After 15 and then 30 patients have reached Day 30 and then Day 90)
- Semi-structured exit interviews(End of study - Day 90 +/-10 from first radiotherapy)