跳至主要内容
临床试验/NCT06117709
NCT06117709
尚未招募
不适用

Integrated Smartphone Technology to Alleviate Malignant Pain (I-STAMP): Development, Usability, and Acceptability Testing

Dana-Farber Cancer Institute1 个研究点 分布在 1 个国家目标入组 73 人2026年5月1日
干预措施I-STAMP

概览

阶段
不适用
干预措施
I-STAMP
疾病 / 适应症
Advanced Cancer
发起方
Dana-Farber Cancer Institute
入组人数
73
试验地点
1
主要终点
Usability
状态
尚未招募
最后更新
上个月

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.

注册库
clinicaltrials.gov
开始日期
2026年5月1日
结束日期
2026年8月30日
最后更新
上个月
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

责任方
Principal Investigator
主要研究者

Andrea Enzinger, MD

Principal Investigator

Dana-Farber Cancer Institute

入排标准

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

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.

研究点 (1)

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