Harnessing Mobile Technology to Deliver Tailored, Brief Pain-CBT for Advanced Cancer Patients on Opioids for Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 6
- 主要终点
- Overall Intervention Adherence Rate
研究概览
简要总结
The purpose of this study is to test whether a mobile application developed to help people with cancer pain is useful and helpful to patients with cancer.
详细描述
This research study involves the use of a smartphone app at home in addition to surveys and potentially an interview at the end of the study.
The research study procedures include screening for eligibility, study interventions include surveys at the beginning of the study, after 4 weeks, and after 6 weeks and use of the smartphone app.
Participants will be on this research study for up to 6 weeks.
It is expected that about 15 people will take part in this research study
This research study is a Feasibility Study, which is the first-time investigators are examining this mobile application meant to help participant to learn behavioral techniques to manage cancer pain. The purpose is to make sure the app is usable and helpful for patients with cancer, and to get feedback about patient experiences after using the app for four weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •PILOT COHORT
- •Age ≥ 18 years
- •Patients diagnosed with an active cancer diagnosis, either undergoing active cancer treatment or receiving treatment for an advanced cancer or are receiving palliative care
- •Treatment managed at participating clinic (DFCI outpatient palliative care, gastrointestinal cancer center, and DFCI satellite clinic Merrimack Valley or Londonderry)
- •Chronic pain related to cancer or treatment (> pain score of 4)
- •Has an active prescription for at least one opioid medication to treat their cancer pain (i.e. not for post-surgical pain)
- •Own a compatible smartphone (android) or is willing to use an android device provided by the study team
- •Completes baseline survey
排除标准
- •Patients in survivorship: patients who have completed their treatment regimens, are not actively receiving treatment for an advanced cancer, or have a cancer that is in remission
- •Cognitive impairment that would interfere with study participation, as judged by treating clinician
- •Inability to speak English: the intervention has not yet been translated to Spanish
- •History of opioid use disorders
- •Enrolled in hospice
- •Currently hospitalized
- •Use of transmucosal fentanyl, given safety concerns and ongoing risk mitigation program required to prescribe these (TIRF REMS).
- •Pain primarily related to a recent surgery
结局指标
主要结局
Overall Intervention Adherence Rate
时间窗: 4 Weeks
\>70% of subjects complete \>4 of the 6 pain-CBT modules and patients will complete 50% of surveys by the end of 4 weeks (completion of the 4-week intervention study period)
Acceptability Rate
时间窗: 4 weeks
Participants completed a modified version of the Acceptability E-scale, rating the app on a 5-point Likert scale (1-5), across 5 unique items on the following 5 domains: understandability, enjoyability, ease of use, time required to use it, and overall satisfaction.\[Tariman, 2011\] Higher scores indicated greater acceptability. Acceptability was pre-defined as \>80% across all acceptability items rated as \>4 or higher out of 5. Acceptability was evaluated by determining the mean score of all items for all participants (range of scale of score 1-5).
次要结局
- Number of Enrolled Participants Who Consented and Completed the Study(7 Months)
- Study Retention(6 Months)
- COMPREHENSIVE ENDPOINT(6 Weeks)
研究者
Desiree R. Azizoddin PsyD
Principal Investigator
Dana-Farber Cancer Institute