Integrated Smartphone Technology to Alleviate Malignant Pain (I-STAMP): Development, Usability, and Acceptability Testing
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Usability
研究概览
简要总结
The purpose of the study is to evaluate if the smartphone app, I-STAMP (Integrated Smartphone Technology to Alleviate Malignant Pain), helps participants with cancer pain manage symptoms and keep track of medications.
详细描述
The goal of this study is to develop and refine I-STAMP (Integrated Smartphone Technology to Alleviate Malignant Pain), an electronic health record-integrated mobile health (mHealth) application designed to support advanced cancer patients and care teams in pain management.
The research study procedures include screening for eligibility, surveys, and interviews. It is expected that up to 73 participants will take part in this research study. Activities 1-3 are non-interventional and will be used to collect data for application development.
Activity 4: This activity will be interventional and will be added with a future amendment.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for Participants (Activities 1a, 2a, 3a):
- •Age ≥ 21 years
- •Current or previous diagnosis of advanced cancer
- •Current or previous experience with cancer pain
排除标准
- •for Participants (Activities 1a, 2a, 3a):
- •Inability to understand, speak, or read English
- •Any condition that would impede the patient's ability to complete study procedures such as visual impairment or significant cognitive impairment as determined by the participant's treating provider.
研究组 & 干预措施
I-STAMP Testing
Study procedures will be conducted as follows:
Activities 1-3: Data Collection for application development
Activity 4: To be added with future amendment
干预措施: I-STAMP (Behavioral)
结局指标
主要结局
Usability
时间窗: 2 weeks
Patients will complete a validated 10-item system usability scale (SUS) with total scores ranging from 0-100, where a score of 100 being the best possible usability score.
E-scale Acceptability
时间窗: 2 weeks
Patients will rate overall acceptability of the application using a modified acceptability e-scale. This 6-item measure asks patients to rate the app on ease of use, understandability, enjoyment, helpfulness, time spent, and overall satisfaction, on a 1 to 5 Likert scale. Items are summed to for a total score, ranging from 6 to 30 with 30 being the highest acceptability score.
次要结局
未报告次要终点
研究者
Andrea Enzinger, MD
Principal Investigator
Dana-Farber Cancer Institute