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

3 giugno 2026 aggiornato da: Dr Joyce Chung, The Hong Kong Polytechnic University

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:

  • 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

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

54

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Cina
    • Jiangsu
      • Kunshan, Jiangsu, Cina, 215300
        • Kunshan First People's Hospital Affiliated to Jiangsu University
        • Contatto:
      • Suzhou, Jiangsu, Cina, 215000
        • The Second Affiliated Hospital of Soochow University
        • Contatto:
      • Suzhu, Jiangsu, Cina, 215000
        • The First Affiliated Hospital of Soochow University
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Intervention group
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.
Altro: Emotional 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

Altri nomi:
  • AI-Integrated Emotional Granularity Growth (AI-EGG)
Altro: Routine 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.
Comparatore attivo: Control group
Participants in the control group will receive routine psychological care provided by oncology nurses.
Altro: Routine 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Recruitment Rate
Lasso di tempo: 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.
During the recruitment period, up to 1 months
Retention Rate
Lasso di tempo: Immediately post-intervention at 4 weeks
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
Lasso di tempo: 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.
Immediately post-intervention at 4 weeks
Feasibility of Outcome Assessment
Lasso di tempo: 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.
Immediately post-intervention at 4 weeks and 1-month post-intervention follow-up
Ecological Momentary Assessment (EMA) Completion Rate
Lasso di tempo: 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.
During the 4-week intervention period
System Usability as Measured by the System Usability Scale (SUS)
Lasso di tempo: 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.
Immediately post-intervention at 4 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Resilience Measured by the Chinese Version of the 10-item Connor-Davidson Resilience Scale (CD-RISC-10)
Lasso di tempo: 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.
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)
Lasso di tempo: 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.
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)
Lasso di tempo: 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.
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)
Lasso di tempo: 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.
Baseline (T0), immediately post-intervention at 4 weeks (T1), and 1-month post-intervention follow-up (T2)

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Participant Acceptability of AI-Integrated Emotional Granularity Growth (AI-EGG)
Lasso di tempo: Immediately post-intervention (T1)
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)
Perceived accuracy of AI emotion interpretation at T1
Lasso di tempo: Immediately post-intervention at 4 weeks (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.
Immediately post-intervention at 4 weeks (T1)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

The Hong Kong Polytechnic University

Collaboratori

The First Affiliated Hospital of Soochow University
Second Affiliated Hospital of Soochow University
Kunshan First People's Hospital Affiliated to Jiangsu University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

1 ottobre 2026

Completamento dello studio (Stimato)

1 dicembre 2026

Date di iscrizione allo studio

Primo inviato

12 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

22 maggio 2026

Primo Inserito (Effettivo)

28 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • HSEARS20260427001

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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