Effectiveness of an Educational Intervention Aimed at Increasing the Emotional Competencies of Patients Under Surveillance After Antineoplastic Treatment of Oesogastric or Bronchopulmonary Cancer: a Randomized, Multicenter, Controlled Pilot Study (EmoVie-K2)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Change in patient emotional skills from baseline to 15 days after the end of intervention
研究概览
简要总结
Emotional skills are the ability to use emotions cleverly in daily life. Good emotional skills are associated with better mental and physical health in healthy and clinical populations. However, to our knowledge, cancer patients have never benefited from an intervention aiming at increasing their emotional skills. Our goal was thus to design and test such an intervention. A prospective, multi-center, randomized controlled trial (RCT) will be conducted in esogastric and lung cancer patients after antineoplastic treatments. Forty-three patients are expected in each arm. The primary outcome is the change in emotional skills assessed using a patient-reported validated questionnaire between the start and two weeks after the end of the intervention and at 2-month follow-up. The experimental arm will have to follow three individual sessions on emotional skills (i.e. identification, understanding, expression and regulation of emotions) while the control arm will have to follow three sessions of relaxation. In each arm, the first session can be held face to face or over the phone and the last two sessions will be held over the phone. Patients have exercises to practice in between sessions.It is hypothesised that the experimental group will experience a greater increase in emotional skills than the control 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
- 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
- •Patient under surveillance after curative or palliative antineoplastic treatment (surgery and/or chemoradiotherapy and/or radiotherapy alone and/or chemotherapy alone) of esogastric or bronchopulmonary cancer,
- •Patients with a life expectancy estimated by their physician involved in the research to be greater than or equal to six months,
- •Patient with a ≥ 4 score on the Distress Scale (scale from 0 to 10),
- •Affiliation to a social security scheme,
- •Mastery of the French language,
- •Signing of informed consent to participate in this research.
排除标准
- •Cognitive disorders or unstabilized psychiatric disorders that may impair the ability of reasoning and thinking necessary to complete the questionnaires and attend workshops
- •Difficulty or deficiency that prevent the patient from a good understanding of the imperatives of the research
- •Any situation likely to significantly affect emotional competence during the study according to the investigator's judgment (in particular, ongoing psychotherapeutic follow-up))
- •Patients under judicial protection (guardianship or curators).
结局指标
主要结局
Change in patient emotional skills from baseline to 15 days after the end of intervention
时间窗: Between Baseline (T0) and 15 days after the intervention (T1)
Variation in patient-reported 13-item Short Profile of Emotional Competence (S-PEC) score from baseline (T0) to 15 days after the intervention (T1)
次要结局
- Patient satisfaction(T1 (15 days after the end of the intervention) and T2 (2 months after T1))
- Patient emotional skills at follow up(Between T0 (start of the intervention) and T2 (2 months after T1))
- Difficulties in Emotional Regulation(Between T0 (baseline) and T1 (15 days after the end of the intervention) and between T1 and T2 (2 months after T1))
- Patient participation in workshops(Between 2 weeks and 2 months)
- Patient adherence to exercises to do at home between sessions(Between 2 weeks and 2 months)
- Quality of life by FACT-G(At T0 (before the first session), at T1 (15 days after the last session) and at T2 (2 months after T1).)
- Change in quality of life using FACT-G(Between T0 (baseline) and T1 (&5 days after the end of the intervention) and between T1 and T2 (2 months after T1))