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 ID: NCT06484842

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2025-06-01

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.

Conditions

Esophageal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

The combined intervention group

The combined intervention group will receive the combined psychological resilience and self-efficacy intervention.

Group Type: EXPERIMENTAL

The combined psychological resilience and self-efficacy intervention

Intervention Type: OTHER

Based on the content of the literature analysis and the group's previous research, a joint intervention programme on psychological resilience and self-efficacy for patients undergoing surgery for oesophageal cancer has been developed. The programme consists of 6 sessions in total, including preoperative period and one month after discharge, covering the period when patients' postoperative symptoms occur most severely. The intervention will be conducted in an individual, offline face-to-face format during the patients' hospital stay; considering the smooth implementation of the intervention after the patient will be discharged from the hospital, we will conduct the intervention in an individual, offline face-to-face format during the patient's outpatient review, and set up a WeChat group in case the patients are at home to conduct the intervention in the form of an online punch card.

The single intervention group

The single intervention group will receive the mindfulness intervention.

Group Type: EXPERIMENTAL

The mindfulness intervention

Intervention Type: OTHER

The oesophageal cancer surgery patients in the single intervention group will receive 5 sessions of mindfulness intervention consistent with the mindfulness intervention component of the combined intervention programme. The intervention will be conducted in an individual, offline face-to-face format during the patients' hospitalisation; we will conduct the intervention in an individual, offline face-to-face format during the patients' outpatient review, and set up a WeChat group in case the patients are at home in the form of an online punch card. Each session will include a pre-session reflection and post-session homework. The whole process will be supervised and reminded by interventionists, who will respond to patients' questions in a timely manner to ensure patients safety and the smooth implementation of the intervention. Adjustments and improvements will be made at any time according to the needs of patients undergoing oesophageal cancer surgery.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

The combined psychological resilience and self-efficacy intervention

Based on the content of the literature analysis and the group's previous research, a joint intervention programme on psychological resilience and self-efficacy for patients undergoing surgery for oesophageal cancer has been developed. The programme consists of 6 sessions in total, including preoperative period and one month after discharge, covering the period when patients' postoperative symptoms occur most severely. The intervention will be conducted in an individual, offline face-to-face format during the patients' hospital stay; considering the smooth implementation of the intervention after the patient will be discharged from the hospital, we will conduct the intervention in an individual, offline face-to-face format during the patient's outpatient review, and set up a WeChat group in case the patients are at home to conduct the intervention in the form of an online punch card.

Intervention Type: OTHER

The mindfulness intervention

The oesophageal cancer surgery patients in the single intervention group will receive 5 sessions of mindfulness intervention consistent with the mindfulness intervention component of the combined intervention programme. The intervention will be conducted in an individual, offline face-to-face format during the patients' hospitalisation; we will conduct the intervention in an individual, offline face-to-face format during the patients' outpatient review, and set up a WeChat group in case the patients are at home in the form of an online punch card. Each session will include a pre-session reflection and post-session homework. The whole process will be supervised and reminded by interventionists, who will respond to patients' questions in a timely manner to ensure patients safety and the smooth implementation of the intervention. Adjustments and improvements will be made at any time according to the needs of patients undergoing oesophageal cancer surgery.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anhui Medical University School of Nursing Qingmiao Programme

UNKNOWN

Sponsor Role: collaborator

Natural Science Foundation of Anhui Provincial Department of Education

UNKNOWN

Sponsor Role: collaborator

Anhui Medical University

OTHER

Sponsor Role: lead

Responsible Party

Jinghan Zhao

Master candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Jinghan Zhao, BSN

Role: CONTACT

zhaojh0103@126.com

+8613855127412

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

83242327

Identifier Type: -

Identifier Source: org_study_id