Effects of a Multifaceted Teleguided Pain Care Program in Patients With Cancer Pain
试验速览
- 阶段
- 不适用
- 入组人数
- 174
- 试验地点
- 2
- 主要终点
- Change in pain intensity (Brief Pain Inventory - Short Form (BPI-SF)
研究概览
简要总结
Pain is a prevalent and distressing symptom in patients with cancer, having an enormous impact on functioning and quality of life. Integration of patient self-management and professional care by means of care technology provides new opportunities in the outpatient setting. In this project a technology based and nurse delivered multicomponent self-management support intervention has been developed. Important components include monitoring, feedback, education, and nurse support. Following feasibility evaluation, the primary aim of this randomized controlled trial is to assess the effect of the intervention regarding pain intensity and quality of life as compared to care as usual. Secondary outcomes of the effect evaluation are self-efficacy, knowledge, anxiety and depression, and pain medication use. Besides, a cost-evaluation and summative process evaluation will be performed.
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
- Single (Outcomes Assessor)
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
- •Diagnosis of cancer
- •Patients who are under (palliative) anti-tumour treatment in a day clinic or outpatient clinic, or patients who have no treatment options available anymore
- •Cancer (treatment related) pain > 2 weeks
- •Pain is defined as a patient reported pain score of 4 or more on a numerical rating scale (scale 0-10)
- •Living at home
排除标准
- •Expected life expectancy < 3 months
- •Chronic non-cancer pain
- •Known cognitive impairments
- •Participation in other studies that interfere with this study
- •Not being able to read and understand the Dutch language
- •Reduced vision
- •Non-reachable by phone
结局指标
主要结局
Change in pain intensity (Brief Pain Inventory - Short Form (BPI-SF)
时间窗: 12 weeks
As measured with the Brief Pain Inventory - Short Form (BPI-SF)
Change in cancer related quality of life (European Organisation for Research and Treatment of Cancer Quality of life Questionnaire (EORTC QLQ-C30 version 3)
时间窗: 12 weeks
As measured with the European Organisation for Research and Treatment of Cancer Quality of life Questionnaire (EORTC QLQ-C30 version 3)
次要结局
- Change in self-efficacy (Chronic Pain Self-efficacy Scale (CPSS)(12 weeks)
- Change in knowledge about cancer pain (Pain Knowledge Questionnaire (PKQ)(12 weeks)
- Change in anxiety and depression (Hospital Anxiety and Depression Scale (HADS)(12 weeks)
- Change in pain medication use (Brief Pain Inventory - Short Form (BPI-SF), a cost diary and a pharmacist's overview)(12 weeks)