" Revie ⊕" Impact of a Resource-based Life Review Intervention on Patients With Advanced Cancer in an Outpatient Oncology Center: a Waitlist Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Self-esteem
研究概览
简要总结
The main objective of the present study is to evaluate the effects of the Revie ⊕ intervention on the self-esteem of patients diagnosed with an advanced cancer. A pragmatic, two-arm parallel-group, waitlist randomized controlled trial is conducted. The study takes place in the oncology department of the University Hospitals of Geneva at 3 outpatient units.
详细描述
The main objective of the present study is to evaluate the effects of the Revie ⊕ intervention on the self-esteem of patients diagnosed with an advanced cancer. The secondary objectives are to evaluate the effects of the Revie ⊕ intervention on spiritual well-being, personal development, life satisfaction, and the perception of the interaction with the nurses. A pragmatic, two-arm parallel-group, waitlist randomized controlled trial (WLRCT) is conducted in which participants are randomized into (i) intervention, or (ii) waitlist control groups. The intervention group (IG) receives the Revie ⊕ intervention early on and the control group (CG) the same intervention but later on (i.e., after eight weeks).This monocentric study takes place in the oncology department of the University Hospitals of Geneva (HUG) at two outpatient units (planned n=102; 51 per group).
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
- •Adults 18 years with and advanced cancer,
- •whose general health status is adequate for participation in the study based on a clinical assessment by the nurse / doctor; and
- •who consent to participate in the study.
排除标准
- •documented cognitive impairment that compromises capacity for discernment,
- •command of French is insufficient for reading, writing, or conversing.
研究组 & 干预措施
Revie ⊕ intervention early
participants randomized into (i) the intervention group (IG) receive the Revie ⊕ intervention early on.
干预措施: Revie ⊕ (Behavioral)
Revie ⊕ intervention later
The control group (CG) receives the same intervention Revie ⊕ but later on (i.e., after eight weeks).
干预措施: Revie ⊕ (Behavioral)
结局指标
主要结局
Self-esteem
时间窗: Baseline, change from Baseline at 2 months, change from Baseline at 4 months
Self-esteem will be measured by the Rosenberg Self-Esteem Scale (RSE, 10 items) developed in 1965 (French version). Minimum value = 1 Maximum value = 4. A score above 30 points corresponds to a high level of self-esteem, between 20 and 30 points indicates a moderate self-esteem, and a score of less than 20 points reflects a low self-esteem.
次要结局
- The patient's perception of their interaction with the nurse(Baseline, change from Baseline at 2 months, change from Baseline at 4 months)
- Personal development(Baseline, change from Baseline at 2 months, change from Baseline at 4 months)
- Spiritual well-being(Baseline, change from Baseline at 2 months, change from Baseline at 4 months)
- Satisfaction with life(Baseline, change from Baseline at 2 months, change from Baseline at 4 months)
研究者
Gora Da Rocha
Professor assistant
School of Health Sciences Geneva