Efficacy of a Personalized Modular Intervention to Promote Dignity, Meaningfulness and Mindfulness by a Palliative Care Consultation-Liaison Service in Swiss Acute Hospital Care. A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in acceptability of the personalized modular Intervention (motivation, satisfaction with Intervention, further recommendation)
研究概览
简要总结
Feasibility study to test the feasibility and acceptability of a designed personalized modular Intervention consisting of three modules, including Cancer and Living Meaningfully (CALM) Therapy, Dignity Therapy (DT), and a mindfulness-based Intervention
详细描述
Patient with a life-limiting serious illness commonly experience substantial emotional and spiritual distress, death anxieties, depressive symptoms and loss of dignity and purpose in life. Fostering dignity and meaning and relieving psychological distress have been identified as a core objective for end-of-life care. However, individual's needs for dignity and psychological support at the end of life may vary. Therefore, a personalized approach is needed. On the basis of theoretical frameworks and existing dignity- fostering and meaning- based interventions, as well as an one-day workshop with international experts in the field of palliative care, a personalized modular intervention, consisting of three modules, including CALM Therapy, Dignity Therapy, and a mindfulness-based Intervention, was developed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Informed Consent as documented by signature
- •Patients in palliative situation (i.e. patients suffering from an advanced, incurable, life-limiting disease with multimodal support needs)
- •Estimated life expectancy ≤ 18 months
- •Patients seen by the palliative consultation-liaison service at the University Hospital Basel as an in- or outpatient
- •Willingness and capacity to commit at least three contacts over about 7-10 days
排除标准
- •Being delirious or otherwise substantially cognitively impaired (based on clinical consensus)
- •Being too ill to complete the requirements of the study protocol
- •Unable to understand and speak German
结局指标
主要结局
Change in acceptability of the personalized modular Intervention (motivation, satisfaction with Intervention, further recommendation)
时间窗: baseline until 1-month follow- up
Motivation for participating in the study, Satisfaction with the intervention, and If intervention would be recommended to other patients, measured by a semi-structured interview; assessment at baseline (T0), after the completion of the intervention (T1 = 2 weeks after baseline) and at 1-month follow- up (T2)
Final recruitment rate
时间窗: at baseline (T0)
feasibility of the personalized modular Intervention measured by final recruitment rate
Rate of consent
时间窗: at baseline (T0)
feasibility of the personalized modular Intervention measured by rate of consent
Change in Questionnaire completion rates
时间窗: baseline until 1-month follow- up
feasibility of the personalized modular Intervention measured by rate of completion of questionnaire and expenditure of time for completing questionnaire (in minutes); assessment at baseline (T0), after the completion of the intervention (T1 = 2 weeks after baseline) and at 1-month follow- up (T2)
Rate of eligibility
时间窗: at baseline (T0)
feasibility of the personalized modular Intervention measured by rate of eligibility
Change in Patient adherence
时间窗: baseline until 1-month follow- up
feasibility of the personalized modular Intervention measured by rate of drop- Outs; assessment at baseline (T0), after the completion of the intervention (T1 = 2 weeks after baseline) and at 1-month follow- up (T2)
次要结局
- Change in Patient Health Questionnaire-9 (PHQ-9)(baseline until 1-month follow- up)
- Change in Patient Dignity Inventory (PDI)(baseline until 1-month follow- up)
- Change in Death and Dying Distress Scale (DADDS)(baseline until 1-month follow- up)