4th Affiliated Hospital, School of Medicine, Zhejiang University, China
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- pain intensity
研究概览
简要总结
This study aims to develop and pilot a cloud-based Patient-Reported Outcomes (PROs) management program for home-based cancer pain patients within a hospital setting. It is expected to serve as a reference for improving pain management in home-based cancer care and to provide insights for future related research as well as the broader application and dissemination of the program.
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
- •Aged 18 years or older; Pathologically confirmed diagnosis of cancer with concomitant pain requiring analgesic medication; Alert and oriented, free of psychiatric disorders or cognitive impairment; Adequate comprehension, essentially normal vision and hearing, and basic literacy; Proficient in using a smartphone (patient or primary caregiver), willing to accept cloud-platform follow-up and participate throughout the study; Informed consent and voluntary participation.
排除标准
- •Presence of severe psychiatric disorders; Critically ill or debilitated patients with advanced-stage tumor who are unable to complete the study procedures.
- •Withdrawal Criteria:
- •Voluntary withdrawal or failure to complete the entire study process; Death during follow-up; Occurrence of accidents or clinical deterioration rendering continued participation infeasible; Request to withdraw for any reason.
研究组 & 干预措施
Control Group
The control group received conventional telephone follow-up. Specifically, at 1 week and 3 weeks after discharge, ward follow-up nurses who had undergone standardized training conducted the follow-up using a pre-established checklist. The telephone calls covered pain intensity, location, medication usage, and adverse drug reactions.
Intervention Group
Prior to discharge, a nurse instructed patients on using the cloud-based follow-up platform. Patients then reported outcomes weekly via the platform using the PROMIS-29 profile. The system automatically monitored this data against preset thresholds; any exceedance triggered an alert to the care team for immediate assessment. Based on the reported data, the system also pushed personalized education on pain management and medication. Follow-up calls provided further guidance, including on non-pharmacological techniques to complement analgesic therapy.
干预措施: Proactive monitoring and patient education (Other)
结局指标
主要结局
pain intensity
时间窗: 1 month
Use the Numerical Rating Scale (NRS) to assess pain intensity, with scores ranging from 0 to 10, where a higher number indicates more severe pain.
次要结局
- Medication adherence(1 month)