A Randomised Controlled Study to Evaluate the Effectiveness of the Combined Psychological Resilience and Self-efficacy Intervention for Oesophageal Cancer Surgery Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 123
- Primary Endpoint
- Self-efficacy
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosed with oesophageal cancer by pathological biopsy.
- •Received surgical treatment.
- •Native Chinese speakers and age≥18 years old.
Exclusion Criteria
- •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.
Arms & Interventions
The combined intervention group
The combined intervention group will receive the combined psychological resilience and self-efficacy intervention.
Intervention: The combined psychological resilience and self-efficacy intervention (Other)
The single intervention group
The single intervention group will receive the mindfulness intervention.
Intervention: The mindfulness intervention (Other)
The control group
The control group will receive routine care. Routine care mainly includes postoperative precautions, management of postoperative complications, and postoperative dietary care such as the type, time, and amount of food required, etc. In addition, we will add the patients' WeChat and send relevant health knowledge to the patients regularly. The control group theoretically will not receive any additional psychological interventions. However, they will be entitled to receive either the combined psychological resilience and self-efficacy intervention or the psychological resilience intervention once the combined and single intervention groups have completed the intervention.
Outcomes
Primary Outcomes
Self-efficacy
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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))
Investigators
Jinghan Zhao
Master candidate
Anhui Medical University