A Pilot Study for a Pain Management Smartphone Application for Patients Undergoing Radiation Therapy for Locally Advanced Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Compliance characteristics of patients' use of the pain management smartphone application
研究概览
简要总结
This pilot clinical trial studies a pain management smartphone application for monitoring pain in patients with locally advanced head and neck cancer who are undergoing radiation therapy. The study is also open to patients with esophageal or lung cancer. A smartphone application may allow patients to assess their symptoms in a manner that is closer to real-time than having to recall pain episodes during once weekly on-treatment visits with a health care provider. This real-time monitoring may improve the timing and efficacy of interventions leading to better pain-control and quality of life.
详细描述
PRIMARY OBJECTIVES:
I. Obtain consumer input to determine the optimal way to address and monitor the patient's symptoms.
II. Train patients to use the pain management smartphone application (PMSA) and determine the compliance characteristics and the number of additional on-treatment visits (OTVs) prompted by usage of the application.
OUTLINE:
Selected patients are interviewed for input that will help guide the wording of questions of the PMSA. All patients/caregivers are then instructed to download the PMSA and are demonstrated how to properly use the application. Beginning on the first day of radiation therapy (day 1), patients are instructed to use the PMSA for the duration of their radiation therapy (up to day 50), although the timing may change based on the availability of the app.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- •Radiation oncology patients undergoing 5-7 weeks of definitive radiation therapy for head and neck, esophageal or lung cancer.
- •Ability to understand and the willingness to use the PMSA on the patient's personal smartphone
- •Displays ability to use and understand the PMSA as evidenced by successful response to alarm and successful entries while monitored by the principal investigator (PI)
- •Willing and able to provide informed consent and fill out demographic, disease, and pain assessment questionnaires
- •English speaking
排除标准
- •Radiation oncology patients undergoing palliative courses of radiation
- •Patients who do not own smartphones
- •Patients who are unable to successfully respond to the PMSA alarm and properly enter their data
- •Patients who are unable to eat and drink normally
- •Patients who are unable to validate their understanding of the pain scale
结局指标
主要结局
Compliance characteristics of patients' use of the pain management smartphone application
时间窗: Up to day 50
Summaries of feasibility will be generated using rates (percentages). Descriptive statistics will be used to summarize patient ratings of satisfaction regarding the PMSA, instruction, usage, and future recommendation.
次要结局
- Number of additional OTVs prompted by usage of the application(Up to day 50)
研究者
Jeffrey Friedman
Principal Investigator
Vanderbilt-Ingram Cancer Center