A Randomised Controlled Study to Evaluate the Effectiveness of the Combined Psychological Resilience and Self-efficacy Intervention for Oesophageal Cancer Surgery Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 123
- 主要终点
- Self-efficacy
研究概览
简要总结
The goal of this clinical trial is to evaluate the effectiveness of the combined psychological resilience and self-efficacy intervention in oesophageal cancer surgery patients. The main question it aims to answer is:
Is the combined psychological resilience and self-efficacy intervention program more effective than the single psychological resilience intervention in improving psychological resilience and self-efficacy and reducing anxiety and depression in patients undergoing oesophageal cancer surgery? Researchers will compare the combined psychological resilience and self-efficacy intervention program to the single psychological resilience intervention and routine care to see if the combined intervention can improve psychological resilience and self-efficacy and reduce anxiety and depression in oesophageal cancer surgery patients.
Participants will receive the combined psychological resilience and self-efficacy intervention program in the combined intervention group, the single psychological resilience intervention in the single intervention group and routine care in 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
- •Diagnosed with oesophageal cancer by pathological biopsy.
- •Received surgical treatment.
- •Native Chinese speakers and age≥18 years old.
排除标准
- •Prior to or during the first evaluation, patients who had end-stage illnesses or other chronic ailments including kidney failure, heart failure, etc..
- •Undergoing further supplementary therapies such as neoadjuvant chemotherapy or radiotherapy.
- •Undergoing other systematic psychological therapies.
- •Possess a background of psychopathy or cognitive problems.
- •Patients' baseline anxiety and depression subscale scores are less than 8 points each.
结局指标
主要结局
Self-efficacy
时间窗: before the intervention (T0: 1-3 days before surgery), during the intervention (T1: 7 days after surgery), and after the intervention (T2: 2-3 weeks after discharge)
Self-efficacy will be measured using the General Self-Efficacy Scale (GSES), which was first developed in 1981 by Professor Schwarzer, a leading clinical and health psychologist at the Freie Universität Berlin, Germany, and his colleagues, and has now been translated into several languages and adopted worldwide. At first, it consisted of 20 items with a 4-point scale, but later it was improved to 10 items with a Likert scale of 1-4, ranging from "not at all true" to "exactly true", with higher overall scores indicating stronger self-efficacy of the individual. The scale was translated into Chinese by our scholars Zhang Jianxin and Schwarzer in 1995, and Chineseised by a Chinese scholar Wang Caikang in 2001, with a total of 10 items, an internal consistency coefficient of 0.87, a re-test reliability of 0.83 at an interval of about 10 days, and a half-way reliability of 0.90.
Psychological resilience
时间窗: before the intervention (T0: 1-3 days before surgery), during the intervention (T1: 7 days after surgery), and after the intervention (T2: 2-3 weeks after discharge)
Psychological resilience will be measured using the Connor-Davidson Resilience Scale (CD-RISC), which was developed by American psychologists Connor and Davidson in 2003 based on a research project on post-traumatic stress disorder to measure the level of psychological resilience in the general population and in clinical patients over the past month. It is now widely used to measure levels of psychological resilience in patients with cancer and chronic diseases. The scale consists of 25 items, including three dimensions of resilience, self-improvement, and optimism, and each item is scored on a 5-point Likert scale, with scores of 0-4 indicating from "not true at all" to "true nearly all the time". The total score ranges from 0 to 100, and the higher the score, the higher the psychological resilience. In 2007, Yu Xiaonan and other scholars translated it into Chinese, and the Cronbach's α coefficient was 0.91.
次要结局
- Anxiety and depression(before the intervention (T0: 1-3 days before surgery), during the intervention (T1: 7 days after surgery), and after the intervention (T2: 2-3 weeks after discharge))
研究者
Jinghan Zhao
Master candidate
Anhui Medical University