AzTrials
AzTrials

Colorectal Cancer (CRC)NCT07611071

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

A study testing Emotional granularity training and Routine Care in people with Colorectal Cancer (CRC), run by The Hong Kong Polytechnic University at 3 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Colorectal Cancer (CRC)
What is being tested?
Emotional granularity training and Routine Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
3 sitesChina
Study dates
1 Jun 2026to 1 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • (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.

Who cannot join

  • (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 locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Joyce Oi Kwan Chung, PhD contact

852-27666322

okjoyce.chung@polyu.edu.hk

China3 sites
  • Kunshan First People's Hospital Affiliated to Jiangsu University

    Kunshan, Jiangsu, 215300

    Juan Song, MSN, 86-13913274133, 93930739@qq.com

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215000

    Li Tian, PhD, 86-13862596317, tianlisz@suda.edu.cn

  • The First Affiliated Hospital of Soochow University

    Suzhu, Jiangsu, 215000

    Li Tian, PhD, 86-13862596317, tianlisz@suda.edu.cn

Other trials in China

About this study

Official title: Development and Evaluation of an AI-Integrated Emotional Granularity Growth (AI-EGG) on Enhancing Resilience and Improving Quality of Life in Young and Middle-Aged Colorectal Cancer Survivors

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:

Read more
  • 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
Read the 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.

Being tested
Emotional granularity training, Routine Care
Keywords
Emotional Granularity, Psychological Resilience, Young and Middle-Aged Adults, Colorectal Neoplasms, Emotional Regulation, Quality of Life, Randomized Controlled Trial
Medical subject headings
Colorectal Neoplasms, Emotional Regulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Emotional granularity trainingOther

    Also called AI-Integrated Emotional Granularity Growth (AI-EGG)

    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

  • Routine CareOther

    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.

Study groups in NCT07611071
Study groupRoleWhat they receive
Intervention groupExperimentalParticipants in the intervention group will receive a 4-week AI-EGG intervention delivered through a digital intervention platform, in addition to routine psychological care.
Receives: Other: Emotional granularity training; Other: Routine Care
Control groupActive comparatorParticipants in the control group will receive routine psychological care provided by oncology nurses.
Receives: Other: Routine Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment Rate

    Recruitment rate will be defined as the proportion of eligible participants who consent to participate in the study.

    Measured: During the recruitment period, up to 1 months

  2. Retention Rate

    Retention rate will be defined as the proportion of enrolled participants who complete follow-up assessments at T1

    Measured: Immediately post-intervention at 4 weeks

  3. 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.

    Measured: Immediately post-intervention at 4 weeks

  4. 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.

    Measured: Immediately post-intervention at 4 weeks and 1-month post-intervention follow-up

  5. 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.

    Measured: During the 4-week intervention period

  6. 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.

    Measured: Immediately post-intervention at 4 weeks

Secondary outcomes (4)
  1. 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.

    Measured: Baseline (T0), immediately post-intervention at 4 weeks (T1), and 1-month post-intervention follow-up (T2)

  2. 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.

    Measured: Baseline (T0), immediately post-intervention at 4 weeks (T1), and 1-month post-intervention follow-up (T2)

  3. 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.

    Measured: Baseline (T0), immediately post-intervention at 4 weeks (T1), and 1-month post-intervention follow-up (T2)

  4. 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.

    Measured: Baseline (T0), immediately post-intervention at 4 weeks (T1), and 1-month post-intervention follow-up (T2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2026
  2. Study start1 Jun 2026 (estimated)
  3. Primary completion1 Oct 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07611071
Sponsor's protocol ID
HSEARS20260427001
Status last verified
Jun 2026
First submitted
12 May 2026
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Emotional granularity training and Routine Care in people with Colorectal Cancer (CRC), run by The Hong Kong Polytechnic University at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Joyce Oi Kwan Chung, PhD (852-27666322, okjoyce.chung@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment Rate (time frame: During the recruitment period, up to 1 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in