AI-Integrated Emotional Granularity Training for Resilience and Quality of Life in Colorectal Cancer Survivors

NCT07611071 | Not Yet Recruiting

• 1 other identifier: HSEARS20260427001
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 3

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

Conditions

Colorectal Cancer (CRC)

Keywords

Emotional Granularity; Psychological Resilience; Young and Middle-Aged Adults; Colorectal Neoplasms; Emotional Regulation; Quality of Life; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (6)

• 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.

  Immediately post-intervention at 4 weeks

Secondary Outcomes (4)

• 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)

• 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)

• 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)

• 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)

Other Outcomes (2)

• Perceived accuracy of AI emotion interpretation at T1

  Immediately post-intervention at 4 weeks (T1)

• Participant Acceptability of AI-Integrated Emotional Granularity Growth (AI-EGG)

  Immediately post-intervention (T1)

Study Arms (2)

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.

Other: Emotional granularity training; Other: Routine Care

Control group

ACTIVE COMPARATOR

Participants in the control group will receive routine psychological care provided by oncology nurses.

Other: Routine Care

Interventions

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

Also known as: AI-Integrated Emotional Granularity Growth (AI-EGG)

Intervention group

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.

Control group; Intervention group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• 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

Study Sites (3)

Kunshan First People's Hospital Affiliated to Jiangsu University

Kunshan, Jiangsu, 215300, China

Location

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

Location

The First Affiliated Hospital of Soochow University

Suzhu, Jiangsu, 215000, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Emotional Regulation

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Self-Control; Social Behavior; Behavior

Central Study Contacts

Joyce Oi Kwan Chung, PhD

CONTACT

852-27666322; okjoyce.chung@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 28, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 4, 2026

Record last verified: 2026-06

Locations

CN (3)