Pain Management in Cancer Patients Using a Mobile Application
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Pain symptoms using the Brief Pain Inventory
研究概览
简要总结
The investigators have developed a mobile application (for use on smart phones) to help cancer patients better manage cancer pain. This study is a randomized controlled trial to evaluate the effect of this mobile-based intervention. The investigators' hypothesis is that subjects randomized to the intervention group will have a reduction in pain and pain-related hospitalizations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •All adult patients, 18 years and above suffering from solid-organ cancer.
- •Diagnosed with moderate or severe cancer pain (i.e. pain intensity score of at least 4/10 on numeric rating scale (NRS)) at the Massachusetts General Hospital (MGH) Palliative Care Center, as determined by the patient's care provider at the MGH Palliative Care Center. Subjects do not need to experience a specific nature of pain for eligibility.
- •Patients must be ambulatory and not currently admitted to the hospital at time of enrollment.
- •Must have a smart phone and be willing to download the study application (Phase II only)
- •Must be able to read and speak English.
排除标准
- •Life expectancy less than 2-months as determined by the palliative care provider
- •Significant medical or psychiatric co-morbidities (other than depression or anxiety) or cognitive impediments that would prevent participant from being able to utilize the program
- •Known history of substance abuse
- •Patients currently on investigational therapies or other study protocols that may have an impact on pain intensity or quality of life which are main outcomes of this intervention.
研究组 & 干预措施
Intervention
The intervention group will use the study's mobile application during the 8-week study.
干预措施: ePAL Mobile Application (Other)
Control
The control group will not use the study's mobile application during the study.
结局指标
主要结局
Pain symptoms using the Brief Pain Inventory
时间窗: up to 8 weeks
The primary aim is to assess the effect of a tailored, multi-dimensional mobile-based intervention on the intensity of cancer pain in cancer patients with moderate to severe pain.
次要结局
- Pain related hospitalization from the Electronic Health Record(up to 8 weeks)
- Patient-related barriers to pain management using the Barriers Questionnaire-II(up to 8 weeks)
- Engagement as tracked by the app(up to 8 weeks)
- Anxiety symptoms using the Generalized Anxiety Disorder (GAD-7)(up to 8 weeks)
- Quality of life using the Functional Assessment of Cancer Therapy (FACT-G)(up to 8 weeks)
研究者
Mihir M. Kamdar,M.D.
Attending Physician
Massachusetts General Hospital