Esophageal CancerNCT06484842
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
A study testing The combined psychological resilience and self-efficacy intervention and The mindfulness intervention in people with Esophageal Cancer, run by Anhui Medical University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- The combined psychological resilience and self-efficacy intervention and The mindfulness intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with oesophageal cancer by pathological biopsy.
- Received surgical treatment.
- Native Chinese speakers and age≥18 years old.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomised Controlled Study to Evaluate the Effectiveness of the Combined Psychological Resilience and Self-efficacy Intervention for Oesophageal Cancer Surgery Patients
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
- Being tested
- The combined psychological resilience and self-efficacy intervention, The mindfulness intervention
- Keywords
- Esophageal Neoplasms; Resilience, Psychological; Self Efficacy
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The combined psychological resilience and self-efficacy interventionOther
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 mindfulness interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| The combined intervention group | Experimental | The combined intervention group will receive the combined psychological resilience and self-efficacy intervention. Receives: Other: The combined psychological resilience and self-efficacy intervention |
| The single intervention group | Experimental | The single intervention group will receive the mindfulness intervention. Receives: Other: The mindfulness intervention |
| The control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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 outcomes (1)
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Jul 2024 (estimated)
- Primary completion31 Mar 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 123 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Natural Science Foundation of Anhui Provincial Department of Education
- Responsible party
- Principal investigator, Jinghan Zhao, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06484842
- Sponsor's protocol ID
- 83242327
- Status last verified
- Jun 2024
- First submitted
- 26 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Study to Evaluate the Effectiveness of the Combined Psychological Resilience and Self-efficacy Intervention for Oesophageal Cancer Surgery Patients
- ClinicalTrials.gov ID
- NCT06484842
- Acronym / sponsor ID
- 83242327
- Conditions
- Esophageal Cancer
- Keywords
- Esophageal Neoplasms; Resilience, Psychological; Self Efficacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 123 participants (estimated)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Collaborators
- Natural Science Foundation of Anhui Provincial Department of Education
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The combined intervention group | Experimental | Other: The combined psychological resilience and self-efficacy interventionThe combined intervention group will receive the combined psychological resilience and self-efficacy intervention. |
| The single intervention group | Experimental | Other: The mindfulness interventionThe single intervention group will receive the mindfulness intervention. |
| The control group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with oesophageal cancer by pathological biopsy.
- Received surgical treatment.
- Native Chinese speakers and age≥18 years old.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The combined psychological resilience and self-efficacy interventionBased 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. | Other | The combined intervention group |
| The mindfulness interventionThe 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. | Other | The single intervention group |
Primary outcome
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.
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.
1 secondary outcome
Anxiety and depression
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing The combined psychological resilience and self-efficacy intervention and The mindfulness intervention in people with Esophageal Cancer, run by Anhui Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jinghan Zhao, BSN (+8613855127412, zhaojh0103@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.