Evaluation of the Effectiveness of the Combined Psychological Resilience and Self-efficacy Intervention for Improving Resilience and Self-efficacy and Reducing Anxiety and Depression of Oesophageal Cancer Surgery Patients
NCT Number: NCT06484842
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Esophageal Cancer
Interventions: OTHER: The combined psychological resilience and self-efficacy intervention|OTHER: The mindfulness intervention
Sponsor: Anhui Medical University
Collaborators: Anhui Medical University School of Nursing Qingmiao Programme|Natural Science Foundation of Anhui Provincial Department of Education
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 123
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07-01
Completion Date: 2025-06-01

Summary:
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.

Primary Outcome Measures: Psychological resilience, 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., 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, 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., 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)
Secondary Outcome Measures: Anxiety and depression, Anxiety and depression will be measured using the Hospital Anxiety and Depression Scale (HADS), which was developed by Zigmond et al. in 1983 and is a simple and easy-to-use scale with good reliability, validity, and psychometric properties. It consists of two subscales, anxiety and depression, with a total of 14 entries, of which 7 entries (single number) assess anxiety and 7 entries (double number) assess depression, and it is a self-assessment 4-rating scale, i.e., each entry is divided into four rating scales, which are recorded as 0, 1, 2, and 3, respectively, and the total scores of both anxiety and depression subscales range from 0-21. This scale was introduced to China in 1993 by Ye Weifei and other scholars, and was revised and translated into a Chinese version suitable for the Chinese population, with reliability analyses confirming that the coefficients of the anxiety and depression subscales were 0.72 and 0.68, and the total Cronbach's α coefficient was 0.785., 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)