Colorectal Cancer (CRC)
Conditions
Keywords
Emotional Granularity, Psychological Resilience, Young and Middle-Aged Adults, Colorectal Neoplasms, Emotional Regulation, Quality of Life, Randomized Controlled Trial
Brief summary
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
Detailed description
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.
Interventions
OTHEREmotional granularity training
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
OTHERRoutine Care
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.
Sponsors
The Hong Kong Polytechnic University
The First Affiliated Hospital of Soochow University
Second Affiliated Hospital of Soochow University
Kunshan First People's Hospital Affiliated to Jiangsu University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* (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.
Exclusion criteria
* (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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Rate | During the recruitment period, up to 1 months | Recruitment rate will be defined as the proportion of eligible participants who consent to participate in the study. |
| Retention Rate | Immediately post-intervention at 4 weeks | 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 | Immediately post-intervention at 4 weeks | 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 | Immediately post-intervention at 4 weeks and 1-month post-intervention follow-up | 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. |
| Ecological Momentary Assessment (EMA) Completion Rate | During the 4-week intervention period | 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. |
| System Usability as Measured by the System Usability Scale (SUS) | Immediately post-intervention at 4 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resilience Measured by the Chinese Version of the 10-item Connor-Davidson Resilience Scale (CD-RISC-10) | Baseline (T0), immediately post-intervention at 4 weeks (T1), and 1-month post-intervention follow-up (T2) | 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) | Baseline (T0), immediately post-intervention at 4 weeks (T1), and 1-month post-intervention follow-up (T2) | 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) | Baseline (T0), immediately post-intervention at 4 weeks (T1), and 1-month post-intervention follow-up (T2) | 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) | Baseline (T0), immediately post-intervention at 4 weeks (T1), and 1-month post-intervention follow-up (T2) | 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. |
Countries
China
Contacts
CONTACTJoyce Oi Kwan Chung, PhD
Outcome results
None listed