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| Name | Class |
|---|---|
| The First Affiliated Hospital of Soochow University | OTHER |
| Second Affiliated Hospital of Soochow University | OTHER |
| Kunshan First People's Hospital Affiliated to Jiangsu University | OTHER |
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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:
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:
This study is a randomized controlled trial designed to evaluate the feasibility, acceptability, and preliminary effectiveness of an AI-integrated Emotional Granularity Growth intervention (AI-EGG) in improving resilience, quality of life emotional granularity and emotion regulation among young and middle-aged colorectal cancer (CRC) survivors.
CRC survivors in early and middle adulthood often experience persistent psychological adaptation difficulties after completion of primary treatment, even when clinical disease is stable. These difficulties include reduced resilience, impaired emotion regulation, and decreased quality of life. Emotional processes are considered central to post-treatment psychological adaptation, and resilience is conceptualized as a key psychosocial outcome reflecting individuals' ability to adapt to cancer-related adversity.
Emotion regulation is an important determinant of resilience; however, existing interventions typically focus on general emotion regulation strategies without directly targeting the individual's ability to differentiate and label emotional experiences. Emotional granularity, defined as the ability to distinguish and accurately label discrete emotional states, is proposed as a cognitive-affective mechanism that may enhance emotion regulation effectiveness and thereby support resilience.
The AI-EGG intervention is developed based on this theoretical framework and is delivered via an online chatbot platform. The intervention is structured as a 4-week program that provides guided, interactive training in emotional granularity. The chatbot system delivers standardized yet interactive modules focusing on emotional identification, emotional differentiation, emotion regulation, and reflective emotional processing. Participants are encouraged to engage with the system at least twice per week, with additional voluntary engagement supported by the platform.
The study adopts a parallel-group randomized controlled design. Participants are randomly assigned to either the AI-EGG intervention group or a control group receiving routine psychological care and standard educational materials. The intervention is delivered remotely through a mobile-based chatbot system, enabling flexible and repeated engagement in real-life contexts.
Outcome assessments are conducted at baseline, immediately after the 4-week intervention period, and at 1-month follow-up. These assessments evaluate changes in emotional granularity, emotion regulation, resilience, and quality of life over time.
In addition to quantitative evaluation, a qualitative component is conducted among a purposively selected subset of participants in the intervention group. Semi-structured interviews are used to explore participants' experiences of using the AI-EGG system, perceived changes in emotional granularity and resilience, engagement patterns, and perceived acceptability of the intervention.
Overall, this study aims to provide preliminary evidence on whether an AI-based emotional granularity training program can improve emotional granularity and support resilience in CRC survivors, and to inform the development of scalable digital psychosocial interventions in oncology care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Participants in the intervention group will receive a 4-week AI-EGG intervention delivered through a digital intervention platform, in addition to routine psychological care. |
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| Control group | Active Comparator | Participants in the control group will receive routine psychological care provided by oncology nurses. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emotional granularity training | Other | The 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Rate | Recruitment rate will be defined as the proportion of eligible participants who consent to participate in the study. | During the recruitment period, up to 1 months |
| Retention Rate | Retention rate will be defined as the proportion of enrolled participants who complete follow-up assessments at T1 | Immediately post-intervention at 4 weeks |
| 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. | Immediately post-intervention at 4 weeks |
| 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. | Immediately post-intervention at 4 weeks and 1-month post-intervention follow-up |
| Ecological Momentary Assessment (EMA) Completion Rate | EMA completion rate will be assessed as the proportion of completed EMA entries relative to the total number of expected EMA prompts during the intervention period. | During the 4-week intervention period |
| System Usability as Measured by the System Usability Scale (SUS) | The System Usability Scale (SUS) is a 10-item questionnaire assessing perceived usability of the intervention platform. Total scores range from 0 to 100, with higher scores indicating better usability. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (T0), immediately post-intervention at 4 weeks (T1), and 1-month post-intervention follow-up (T2) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joyce Oi Kwan Chung, PhD | Contact | 852-27666322 | okjoyce.chung@polyu.edu.hk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kunshan First People's Hospital Affiliated to Jiangsu University | Kunshan | Jiangsu | 215300 | China |
A final decision regarding sharing individual participant data (IPD) has not yet been finalized. This is due to the need for further internal discussions and consultations with all collaborating institutions, particularly regarding compliance with cross-border data transfer regulations under China's Personal Information Protection Law (PIPL) and ethical guidelines governing participant privacy. Additionally, the feasibility of robust de-identification processes and secure data-sharing mechanisms is being evaluated to ensure participant confidentiality. The final decision will be determined before study completion and will align with journal requirements, participant consent agreements, and institutional policies.
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D000080103 | Emotional Regulation |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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Outcome assessors are blinded to participants' group allocation to reduce assessment bias. Participants are assigned unique study identification codes, and outcome data are collected and analyzed using de-identified datasets to maintain blinding at the analysis stage. The research coordinator responsible for randomization and allocation is not involved in outcome assessment. Although participants are aware of their group assignment due to the nature of the behavioral intervention, access to the AI-EGG intervention is restricted through individual login credentials to minimize cross-group contamination. Backend usage logs are monitored for technical monitoring purposes only and are not accessible to outcome assessors.
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| Routine Care | Other | Routine 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. |
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| Immediately post-intervention at 4 weeks |
| 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. | Baseline (T0), immediately post-intervention at 4 weeks (T1), and 1-month post-intervention follow-up (T2) |
| 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. | Baseline (T0), immediately post-intervention at 4 weeks (T1), and 1-month post-intervention follow-up (T2) |
| 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. | Baseline (T0), immediately post-intervention at 4 weeks (T1), and 1-month post-intervention follow-up (T2) |
| Immediately post-intervention at 4 weeks (T1) |
| 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. | Immediately post-intervention (T1) |
| The Second Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215000 | China |
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| The First Affiliated Hospital of Soochow University | Suzhu | Jiangsu | 215000 | China |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D000068356 | Self-Control |
| D012919 | Social Behavior |
| D001519 | Behavior |