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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Другое 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,
• Другое 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.

Первичные конечные точки

• Recruitment Rate [Срок оценки: During the recruitment period, up to 1 months]
• Retention Rate [Срок оценки: Immediately post-intervention at 4 weeks]
• Adherence to the AI-Integrated Emotional Granularity Growth (AI-EGG) Program [Срок оценки: Immediately post-intervention at 4 weeks]
• Feasibility of Outcome Assessment [Срок оценки: Immediately post-intervention at 4 weeks and 1-month post-intervention follow-up]
• Ecological Momentary Assessment (EMA) Completion Rate [Срок оценки: During the 4-week intervention period]
• System Usability as Measured by the System Usability Scale (SUS) [Срок оценки: Immediately post-intervention at 4 weeks]

Вторичные конечные точки (4)

• Resilience Measured by the Chinese Version of the 10-item Connor-Davidson Resilience Scale (CD-RISC-10) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Baseline (T0), immediately post-intervention at 4 weeks (T1), and 1-month post-intervention follow-up (T2)]

Критерии участия

Критерии включения

• (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.

Критерии исключения

• (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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Китай · 3 центра

• Kunshan First People's Hospital Affiliated to Jiangsu University — Kunshan
• The Second Affiliated Hospital of Soochow University — Сучжоу
• The First Affiliated Hospital of Soochow University — Suzhu

Идентификаторы

NCT: NCT07611071 · HSEARS20260427001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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