A Randomised Controlled Study to Evaluate the Effectiveness of the Combined Psychological Resilience and Self-efficacy Intervention for Oesophageal Cancer Surgery Patients
Phase: NA
Conditions: Esophageal Cancer
Sponsor: Anhui Medical University

Official title: A Randomised Controlled Study to Evaluate the Effectiveness of the 
Combined Psychological Resilience and Self-efficacy Intervention for Oesophageal 
Cancer Surgery Patients 
Unique Protocol ID: 83242327 
Document date: 2024.01.01 
 
 

Study Protocol 
Session 1 
1-3 days before surgery 
Theme 
Know Each Other Well 
Target 
1. 
Inform patients of the intervention plan and the purpose and process of this study; 
2. 
Establish trusting relationships with patients; 
3. 
To understand patients' baseline information. 
Content 
Self-introduction 
Self-introduction and introduce the purpose and process of the intervention 
of this study to patients. 
Strengthen 
disease-related 
knowledge 
guidance and 
health education 
Strengthen the health promotion of preoperative knowledge related to 
oesophageal cancer: Watch the video of oesophageal cancer promotion, 
help patients to have better self-knowledge, correct and guide the wrong 
cognition of the disease in time, give the patients confidence in recovery, so 
that the patients can have the correct cognition and behaviours in the fight 
against the disease. Communicate with patients, listen to their inner feelings 
after diagnosis, care about their emotional feelings, and help them relieve 
their bad emotions as much as possible. About 30min. 
Direct mastery 
experiences 
Patients relieve past experiences of facing significant life changes such as 
diseases or adversity. 
Vicarious 
experiences 
Help patients get to know each other and discuss with patients with similar 
conditions. About 5min. 
Verbal 
persuasion 
During communications with patients, use more encouraging language to 
promote positive expression and learning. 
Arousal states: 
Family support 
Family members should accompany and encourage patients and strengthen 
communication with the patient. 
T0 evaluation 
Instruct patients to fill in the relevant scales (General Situation 
Questionnaire, CD-RISC, GSES, HADS) and answer questions. 
Homework 
Record mindfulness logs (number of times encouraged by the researcher 
and relatives, insights from experiences shared by peers, etc.). 

Session 2 
3-4 days after surgery 
Theme 
Selective Awareness 
Target 
1. 
To guide patients to establish a correct way of thinking about the disease; 
2. 
To strengthen patients' knowledge of postoperative diseases; 
3. 
Initially understand and grasp the theory and content of mindfulness; 
4. 
To understand patients' feelings and recovery after surgery. 
Content 
Strengthen 
disease-related 
knowledge 
guidance and 
health education 
Describe the content of this theme. Distribute health education brochures on 
oesophageal cancer, explaining the prevention and treatment of 
postoperative complications, the types, nature and amount of postoperative 
diet to choose, avoiding the phenomena of fear, anxiety and depression 
brought about by the lack of knowledge or previous wrong perceptions, and 
rebuilding the patients' correct cognition of oesophageal cancer. 
Communicate with patients, listen to their inner feelings after diagnosis, 
care about their emotional feelings, and help them relieve their bad 
emotions as much as possible. About 10min. 
Direct mastery 
experiences 
Patients gain experiences from the diagnosis of the disease to the 
completion of the operation. 
Vicarious 
experiences 
Discussions are held between patients with similar conditions. About 5min. 
Verbal 
persuasion 
During communications with patients, use more encouraging language to 
promote positive expression and learning. 
Arousal states: 
Mindfulness 
interventions + 
Family support 
Explain the theory related to positive thinking and watch the guided video 
of mindfulness meditation, so that patients can initially understand the 
knowledge related to mindfulness meditation and be guided to accept the 
reality of oesophageal cancer. Perform body scanning according to the 
audio prompts of mindfulness, starting from the toes and going up to the top 
of the head, objectively experiencing every part of the body, and guiding 
the patient to use this technique to relieve discomfort when pain or 

discomfort arises. Family members should accompany and encourage 
patients and strengthen communication with the patient. About 15min. 
Homework 
Review mindfulness interventions videos and record mindfulness logs 
(number of times encouraged by the researcher and relatives, insights from 
experiences shared by peers, mindfulness frequency and duration, whether 
relatives accompanied them etc.). 
Session 3 
7 days after surgery (day of discharge) 
Theme 
Cognitive Reconstruction + Environmental Changes 
Target 
1. 
To help patients develop a correct knowledge of the disease; 
2. 
To enhance patients' knowledge of the disease after discharge; 
3. 
Become proficient in positive thinking interventions; 
4. 
To obtain peer and family support. 
Content 
Pre-session 
reflection 
Review the last homework assignment, emphasise the correct way of 
thinking and recall positive mental experiences. Summarise the content of 
the last topic and explain the content of the current topic. 
Strengthen 
disease-related 
knowledge 
guidance and 
health education 
Strengthening patients' post-discharge rehabilitation knowledge, the type, 
nature, and number of dietary choices, to avoid fear, anxiety, and depression 
brought about by a lack of knowledge or previous misperceptions. 
Communicate with patients, listen to their inner feelings after diagnosis, 
care about their emotional feelings, and help patients alleviate their bad 
emotions as much as possible. About 10min. 
Direct mastery 
experiences 
Patients gain experiences from completing the surgery to their current 
recovery. 
Vicarious 
experiences 
Invite patients who have recovered well to make video recordings and pass 
on their recovery experience. Patient exchange meetings are held to discuss 
among patients with similar conditions. About 10min. 
Verbal 
persuasion 
During communications with patients, use more encouraging words to 
promote positive expression and learning. 

Arousal states: 
Mindfulness 
interventions + 
Family support 
Let patients meditate in a quiet environment, observe the thoughts, ideas 
and impulses that appear in their mind at this moment, and observe these 
thoughts, emotions and psychological experiences in their mind 
intentionally and without avoiding them, without criticising or rejecting 
them, accepting them objectively, improving the patients' abilities to 
perceive their own physiological states, so as to enhance the patients' sense 
of self-control, and guiding them to be able to objectively perceive and 
reasonably react to the negative emotions. Family members should 
accompany and encourage patients and strengthen communication with the 
patient. About 15min. 
T1 evaluation 
Instruct patients to complete relevant scales (CD-RISC, GSES, HADS) and 
answer questions. 
Homework 
1. 
Review the method of mindfulness interventions and record 
mindfulness logs (number of times encouraged by the researcher and 
relatives, insights from experiences shared by peers, mindfulness 
frequency and duration, whether relatives accompanied them etc.); 
2. 
Patients share and exchange positive experiences with each other and 
form a WeChat group; 
3. 
Patients dictate a specific event or moving moment of family support 
during the illness. 
Session 4 
14 days after surgery (1 week after discharge) 
Theme 
Active Response 
Target 
1. 
Practice mindfulness interventions diligently; 
2. 
Share positive experiences with other patients and gain peer and family support. 
Content 
Pre-session 
reflection 
Review the last homework assignment, emphasising the correct perception 
of illness and recalling the methods of mindfulness interventions. 
Summarise the content of the last topic and explain the content of the 
current topic. 

Direct mastery 
experiences 
Patients gain experiences from the time they were discharged from hospital 
to their current recovery at home. 
Vicarious 
experiences 
Discussions are held between patients with similar conditions. About 5min. 
Verbal 
persuasion 
Encourage patients by using positive languages and emotions frequently 
within the WeChat group. 
Arousal states: 
Mindfulness 
interventions + 
Family support 
Record mindfulness practices on videos when patients are at home after 
discharge. Family members accompany and encourage patients more, and 
strengthen communication with patients. About 15min once. 
Homework 
1. 
Clock complete mindfulness videos and record mindfulness logs 
within the WeChat group (number of times encouraged by the 
researcher and relatives, insights from experiences shared by peers, 
mindfulness frequency and duration, whether relatives accompanied 
them etc.); 
2. 
Share new positive experiences and communicate with patients with 
each other within the WeChat group; 
3. 
Post a sentence describing a specific event or moving moment of 
family support within the WeChat group. 
Session 5 
3-4 weeks after surgery (2-3 weeks after discharge) 
Theme 
Behavioural Reinforcement 
Target 
1. 
Practice and continually reinforce methods of mindfulness interventions; 
2. 
Enhance access to peer and family support. 
Content 
Pre-session 
reflection 
Review the last homework assignment and reward patients who completed 
it well. Summarise the content of the last topic and explain the content of 
the current topic. 
Direct mastery 
experiences 
Patients gain experiences from their last home recovery to their current 
home recovery. 

Vicarious 
experiences 
Patients share the positive emotional experiences gained during the 
intervention with each other within the WeChat group. 
Verbal 
persuasion 
During outpatient review and communication with patients, use more 
encouraging language to promote positive expression and learning. When 
patients are at home, use positive languages and emoticons more often in 
the WeChat group to encourage patients. 
Arousal states: 
Mindfulness 
interventions + 
Family support 
Instruct and supervise the patient in mindfulness practices during the 
patient's clinic review. Let patients meditate in a quiet environment, observe 
the thoughts, ideas and impulses that appear in their minds at this moment, 
observe these thoughts, emotions and psychological experiences that appear 
in their minds intentionally and without avoiding them, without criticising 
or rejecting them, accept them objectively, improve the patients' ability to 
perceive the reality of their physiological state, thus enhancing their sense 
of self-control, and guiding the patients to be able to objectively perceive 
the negative emotions and to make reasonable reaction.  Family members 
accompany and encourage patients more, and strengthen communication 
with patients. About 15min. 
T2 evaluation 
During outpatient review, instruct patients to fill in relevant scales (CD-
RISC, GSES, HADS) and answer their questions. 
Homework 
1. 
Review the intensive mindfulness intervention methodology, where 
patients clock complete mindfulness videos and record mindfulness 
logs within the WeChat group while at home (number of times 
encouraged by the researcher and relatives, insights from experiences 
shared by peers, mindfulness frequency and duration, whether relatives 
accompanied them etc.); 
2. 
Share new positive experiences with other patients within the WeChat 
group; 
3. 
Post a one-sentence description of a specific event or moving moment 
of family support within the WeChat group. 

Session 6 
5 weeks after surgery (4 weeks after discharge) 
Theme 
Review and Conclusion 
Target 
1. 
Review the entire intervention, summarise the shortcomings of the intervention and 
improve them; 
2. 
Diligent practices and continuous internalisation of the mindfulness interventions; 
3. 
Stable access to peer and family support. 
Content 
Pre-session 
reflection 
Review the last homework assignment, develop patients' abilities to 
internalise thoughts in their daily life and reward better completion. 
Summarise the content of the last topic and explain the content of the 
current topic. 
Direct mastery 
experiences 
Patients gain experiences from their last home recovery to their current 
home recovery. 
Vicarious 
experiences 
Patients share the positive emotional experiences gained during the 
intervention with each other within the WeChat group. 
Verbal 
persuasion 
Encourage patients by using positive languages and emotions frequently 
within the WeChat group. 
Arousal states: 
Mindfulness 
interventions + 
Family support 
Record mindfulness practices on videos when patients are at home after 
discharge and clock in on the WeChat group. Family members accompany 
and encourage patients and strengthen communication with patients. About 
15min once. 
Mindfulness logs 
summary 
Retrieve each patient's mindfulness log to collate the length of intervention, 
number of times, format, whether accompanied or not, etc., and to 
summarise advantages and limitations. 
Homework 
None. 
Note. The text in red refers to the content of mindfulness intervention in the single intervention 
group. 
 
 

Statistical Analysis Plan 
EpiData 3.1 software will be used for data entry and SPSS 25.0 software for statistical analysis, 
with P<0.05 indicating a statistically significant difference. Quantitative data such as demographic 
information will be described using frequency and component ratios, and qualitative data such as 
psychological resilience, self-efficacy, and anxiety and depression will be described using means 
and standard deviations. Comparison of quantitative data between the combined intervention group, 
single intervention group and control group will be performed by chi-square test if it meets normal 
distribution, and vice versa by rank-sum test; and comparison of qualitative data between the three 
groups will be performed by ANOVA. Comparisons between the three groups at pre-intervention, 
mid-intervention and post-intervention will be analysed by ANOVA; differences between the three 
groups at different time points will be analysed by repeated measures ANOVA. Effectiveness will 
be evaluated using both conformity to protocol set analysis (Per-protocol, PP) and intention-to-treat 
(ITT) because of the removal or dropout of patients from the trial. Per-protocol analysis is an 
analysis of subjects who comply with the trial protocol and complete the entire trial, also known as 
"active cases" or "evaluable subjects", which are a subset of the total number of subjects. The 
principle of intentionality analysis is that, in addition to the need to include all subjects with valid 
test results in the analysis of results at the endpoint of the trial, it is also necessary to include 
randomly assigned subjects who discontinued after a period of time in the trial, and missing values 
are treated by carrying over the most recent observation to the endpoint, so that the number of 
subjects in each group at the endpoint is the same as at the beginning of the trial, an analytical 
method that ensures the principle of randomisation. PP analyses can overestimate the efficacy of a 
trial, whereas ITT analyses often underestimate the efficacy of a trial, and it is generally considered 
appropriate to apply both methods of statistical analyses in validation trials, which increases the 
credibility of the findings when the conclusions analysed by the two methods are essentially the 
same.