To hear about similar clinical trials, please enter your email below
Trial Title:
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
Condition:
Esophageal Cancer
Conditions: Keywords:
Esophageal Neoplasms; Resilience, Psychological; Self Efficacy
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
The combined psychological resilience and self-efficacy intervention
Description:
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.
Arm group label:
The combined intervention group
Intervention type:
Other
Intervention name:
The mindfulness intervention
Description:
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.
Arm group label:
The single intervention group
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Diagnosed with oesophageal cancer by pathological biopsy.
- Received surgical treatment.
- Native Chinese speakers and ageā„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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
July 1, 2024
Completion date:
June 1, 2025
Lead sponsor:
Agency:
Anhui Medical University
Agency class:
Other
Collaborator:
Agency:
Anhui Medical University School of Nursing Qingmiao Programme
Agency class:
Other
Collaborator:
Agency:
Natural Science Foundation of Anhui Provincial Department of Education
Agency class:
Other
Source:
Anhui Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06484842
