A Feasibility Study to Evaluate The Effect of the Electronic Patient Visit Assessment On Pain and Quality of Life for Patients With Head and Neck Cancer (HNC)
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Patient completion of 6 out of 7 assessments
研究概览
简要总结
This randomized, non-blinded, phase 0/I study will assess the feasibility of conducting a large randomized clinical trial to evaluate the efficacy of the ePVA to improve pain management and HRQoL in HNC. Thirty participants undergoing radiation therapy (RT) (with or without chemotherapy) will be randomized to: 1) ePVA intervention or 2) usual care. The intervention consists of participants completing the ePVA every other week during radiation therapy (RT), then weeks 4, 12, and 24 after end of RT. Automated reports of ePVA data, including pain reports and patient-reports of pain medications, will be sent to providers to inform their clinical decisions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •To be eligible to participate in this study, an individual must meet all of the following criteria:
- •Histologically diagnosed HNC
- •Undergoing RT with or without chemotherapy,
- •English speaking,
- •aged 18 years or older.
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Unable to attend scheduled appointment due to geographical, social or mental reseaons,
- •In the opinion of the investigator, is unable or unlikely to comply fully with the study requirements or procedures for any reason (e.g. cognitve or physical impairment).
结局指标
主要结局
Patient completion of 6 out of 7 assessments
时间窗: 24 weeks
This is defined as a binary yes/no variable as to whether a participant completed 6 out of 7 assessments.
次要结局
- Change in health-related quality of life(Baseline, week 4, week 12, week 24)
- Change in pain severity(Baseline, Day 7, Day 21, Day 35)