Improvement of Self Management Skills for Oncologic Patients With Pain Through a Trans Institutional Nursing Intervention: a Cluster Randomized Multi Center Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 208
- 试验地点
- 6
- 主要终点
- Patient-related barriers to management of cancer pain (Barriers Questionnaire II)
研究概览
简要总结
This study will test the SCION (Self care improvement through oncology nursing)-PAIN program, a multi-modular structured intervention to improve self management in oncologic patients with pain compared to care as usual (standard pain treatment and standard care). The study will determine if the self management skills of the patients continue to be used when the intervention stops, e.g. after discharge from hospital.
It is hypothesized that patients who receive the multi-modular structured intervention will have less patient-related barriers to the management of cancer pain.
详细描述
According to modified "Precede Model of health behavior" from Green, patients self management skills are affected by the patients' knowledge, activities and attitude to pain management.
Therefore, we conduct a cluster randomized clinical trial (C-RCT) that will test the effectiveness of SCION-PAIN program against care as usual on self pain management of the patient and average pain level.
As allocation to intervention or control is performed on the level of wards, randomization is stratified by ward profile (e.g. gynaecological, haematological, urological).
Wards were included if they agreed to participate and had more than 10% patients with a diagnosis of cancer in 2006. Wards with a pediatric profile were excluded.
Adult oncology patients with persistent pain will be recruited by the nurses of the participating wards under the guidance of a research nurse. Patients are included in the trial if they meet the inclusion criteria and sign informed consent. They will receive the intervention that the respective ward was allocated to.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult oncology patients
- •able to read, write, and understand German
- •agree to participate and give informed consent
- •have an average pain intensity score of > 3.0 on a 0 to 10 NRS
- •pain persists for more than 3 days
- •scheduled for another visit to the clinic
排除标准
- •documented actual alcohol or drug abuse
- •surgery within the last 3 days
- •disorientated to date, place and situation
- •have a ECOG Performance Score of 4
结局指标
主要结局
Patient-related barriers to management of cancer pain (Barriers Questionnaire II)
时间窗: 7 days after discharge
次要结局
- Average pain intensity score (Brief Pain Inventory)(7th day after discharge)
- HRQoL (EORTC QLQ C 30 (Version 3.0))(7th day after discharge)
- Adherence to pain medication (MORISKY Adherence Score)(7th day after discharge)
- Coping of Pain (FESV-BW)(7th day after discharge)