About this trial
The goal of this clinical trial is to evaluate an AI-integrated Emotional Granularity Growth intervention (AI-EGG) designed to enhance resilience and improve quality of life in young and middle-aged colorectal cancer (CRC) survivors. Emotional granularity refers to the ability to clearly identify and differentiate subtle emotional experiences, which may help individuals regulate emotions more effectively and build resilience after cancer treatment.
The main questions it aims to answer are:
* Does the AI-EGG intervention improve resilience in CRC survivors compared with routine psychological care? * Does the intervention improve emotional granularity, emotion regulation ability, and quality of life? * Is the AI-EGG intervention feasible and acceptable for young and middle-aged CRC survivors?
Researchers will compare the AI-EGG intervention group to a control group receiving routine psychological care and standard educational materials to see whether the intervention leads to better psychological outcomes.
Participants will:
* Complete baseline assessments measuring emotional granularity, emotion regulation, resilience, and quality of life * Be randomly assigned to either the intervention group or the control group * In the intervention group, engage in a 4-week AI chatbot-based program focusing on emotional identification, differentiation, regulation, and reflective practice (at least two sessions per week) * In the control group, receive routine psychological care and standard educational materials * Complete post-intervention assessments immediately after the 4-week program and again at a 1-month follow-up * Some participants in the intervention group will be invited to complete interviews about their experience of the program
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
(1) young and middle-aged adult patients (age in the range of 18-60 years);
(2) patients diagnosed with CRC;
(3) patients have completed primary curative-intent treatment for colorectal cancer, and are currently in a stable post-treatment or maintenance phase of care without evidence of active disease progression or acute treatment-related instability;
(4) patients able to use a smartphone and agree to participate in the study.
Disqualifiers
(1) patients who have been informed of their cancer diagnosis due to family decision to withhold information;
(2) patients suffering from severe comorbidities or conditions that may affect participation or assessment, such as significant cognitive impairment (e.g., dementia, severe memory loss), psychiatric disorders, or other serious medical complications;
(3) those who are participating in other psychological intervention studies.
Trial design
Parallel
Treatments tested in this trial
Emotional granularity training
Other interventionThe 4-week Emotional Granularity Growth intervention (AI-EGG) will be delivered via a structured mobile-based digital platform based on emotional granularity theory and Gross's Extended Process Model of Emotion Regulation. The intervention includes four modules: (1) emotional identification and labeling, (2) emotional differentiation training, (3) emotion regulation strategy selection, and (4) implementation and reflective adaptation. Each session follows a cycle of emotional diary recording, labeling, feedback on emotional differentiation, and practice of regulation strategies. Participants are encouraged to complete at least two sessions per week. Predefined emotional categories and structured vocabulary support consistent labeling. Culturally adapted scenarios for young and middle-aged CRC survivors are included. Oncology nurses provide support, including clarification of emotional concepts, guidance on real-life application, and referral when needed
Routine Care
Other interventionRoutine psychological care will be provided by oncology nurses, along with standard educational materials on symptom management and basic emotional coping strategies consistent with clinical guidelines. Participants will also complete the online questionnaires for outcome assessment.
Treatment groups
Trial outcomes
Primary outcomes
Recruitment Rate
Recruitment rate will be defined as the proportion of eligible participants who consent to participate in the study.
Retention Rate
Retention rate will be defined as the proportion of enrolled participants who complete follow-up assessments at T1
Adherence to the AI-Integrated Emotional Granularity Growth (AI-EGG) Program
Adherence will be defined as the proportion of retained participants who complete all core intervention modules and at least 70% of Ecological Momentary Assessment (EMA) entries during the intervention period.
Feasibility of Outcome Assessment
Feasibility of outcome assessment will be evaluated based on the proportion of retained participants who successfully complete all required outcome assessments and follow-up interviews at T1 and T2.
Secondary outcomes
Resilience Measured by the Chinese Version of the 10-item Connor-Davidson Resilience Scale (CD-RISC-10)
The Chinese version of the 10-item Connor-Davidson Resilience Scale (CD-RISC-10) is a 10-item self-report questionnaire assessing psychological resilience. Each item is rated on a 5-point scale from 0 to 4. Total scores range from 0 to 40, with higher scores indicating greater resilience.
Quality of life Measured by the Chinese Version of the Functional Assessment of Cancer Therapy-Colorectal (FACT-C)
The Chinese version of the Functional Assessment of Cancer Therapy-Colorectal (FACT-C, Version 4) is a 36-item disease-specific quality-of-life questionnaire for colorectal cancer patients. Each item is rated on a 5 point Likert scale from 0 ("not at all") to 4 ("very much") over the past 7 days, with higher scores indicating better quality of life.
Emotional granularity Measured by the Chinese Version of the Range and Differentiation of Emotional Experience Scale (RDEES)
The Chinese version of the Range and Differentiation of Emotional Experience Scale (RDEES) is an 11-item self-report scale assessing emotional granularity across two domains: range of emotional experience and emotional differentiation. Total scores range from 11 to 55, with higher scores indicating greater emotional granularity.
Emotion Regulation Measured by the Chinese Version of the Difficulties in Emotion Regulation Scale (DERS)
The Chinese version of the Difficulties in Emotion Regulation Scale (DERS) is a 36-item self-report scale assessing multidimensional difficulties in emotion regulation. Total scores range from 36 to 180, with higher scores indicating greater difficulties in emotion regulation.
Other outcomes
Perceived accuracy of AI emotion interpretation at T1
Perceived accuracy of AI emotion interpretation will be assessed using a 0-10 visual analogue scale completed by participants after each emotion feedback episode. Higher scores indicate greater perceived agreement between the AI-generated emotional interpretation and participants' subjective emotional experience. Scores will be summarised as mean (SD) at the participant level.
Participant Acceptability of AI-Integrated Emotional Granularity Growth (AI-EGG)
Participant acceptability, appropriateness, and perceived suitability of the intervention will be explored through semi-structured qualitative interviews conducted with a purposive subsample of intervention group participants.
Sponsors and contacts
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The Hong Kong Polytechnic University
Lead sponsor
The First Affiliated Hospital of Soochow University
Collaborator
Second Affiliated Hospital of Soochow University
Collaborator
Kunshan First People's Hospital Affiliated to Jiangsu University
Collaborator
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