AI-Integrated Emotional Granularity Training for Resilience and Quality of Life in Colorectal Cancer Survivors
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
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Joyce Oi Kwan Chung, PhD
- 電話番号：852-27666322
- メール：okjoyce.chung@polyu.edu.hk
研究場所
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Jiangsu
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Kunshan、Jiangsu、中国、215300
- Kunshan First People's Hospital Affiliated to Jiangsu University
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コンタクト：
- Juan Song, MSN
- 電話番号：86-13913274133
- メール：93930739@qq.com
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Suzhou、Jiangsu、中国、215000
- The Second Affiliated Hospital of Soochow University
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コンタクト：
- Li Tian, PhD
- 電話番号：86-13862596317
- メール：tianlisz@suda.edu.cn
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Suzhu、Jiangsu、中国、215000
- The First Affiliated Hospital of Soochow University
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コンタクト：
- Li Tian, PhD
- 電話番号：86-13862596317
- メール：tianlisz@suda.edu.cn
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参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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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
他の名前：
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.
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アクティブコンパレータ：Control group
Participants in the control group will receive routine psychological care provided by oncology nurses.
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Recruitment Rate
時間枠：During the recruitment period, up to 1 months
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Recruitment rate will be defined as the proportion of eligible participants who consent to participate in the study.
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During the recruitment period, up to 1 months
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Retention Rate
時間枠：Immediately post-intervention at 4 weeks
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Retention rate will be defined as the proportion of enrolled participants who complete follow-up assessments at T1
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Immediately post-intervention at 4 weeks
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Adherence to the AI-Integrated Emotional Granularity Growth (AI-EGG) Program
時間枠：Immediately post-intervention at 4 weeks
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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.
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Immediately post-intervention at 4 weeks
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Feasibility of Outcome Assessment
時間枠：Immediately post-intervention at 4 weeks and 1-month post-intervention follow-up
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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.
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Immediately post-intervention at 4 weeks and 1-month post-intervention follow-up
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Ecological Momentary Assessment (EMA) Completion Rate
時間枠：During the 4-week intervention period
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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.
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During the 4-week intervention period
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System Usability as Measured by the System Usability Scale (SUS)
時間枠：Immediately post-intervention at 4 weeks
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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.
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Immediately post-intervention at 4 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Resilience Measured by the Chinese Version of the 10-item Connor-Davidson Resilience Scale (CD-RISC-10)
時間枠：Baseline (T0), immediately post-intervention at 4 weeks (T1), and 1-month post-intervention follow-up (T2)
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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.
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Baseline (T0), immediately post-intervention at 4 weeks (T1), and 1-month post-intervention follow-up (T2)
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Quality of life Measured by the Chinese Version of the Functional Assessment of Cancer Therapy-Colorectal (FACT-C)
時間枠：Baseline (T0), immediately post-intervention at 4 weeks (T1), and 1-month post-intervention follow-up (T2)
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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.
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Baseline (T0), immediately post-intervention at 4 weeks (T1), and 1-month post-intervention follow-up (T2)
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Emotional granularity Measured by the Chinese Version of the Range and Differentiation of Emotional Experience Scale (RDEES)
時間枠：Baseline (T0), immediately post-intervention at 4 weeks (T1), and 1-month post-intervention follow-up (T2)
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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.
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Baseline (T0), immediately post-intervention at 4 weeks (T1), and 1-month post-intervention follow-up (T2)
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Emotion Regulation Measured by the Chinese Version of the Difficulties in Emotion Regulation Scale (DERS)
時間枠：Baseline (T0), immediately post-intervention at 4 weeks (T1), and 1-month post-intervention follow-up (T2)
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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.
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Baseline (T0), immediately post-intervention at 4 weeks (T1), and 1-month post-intervention follow-up (T2)
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Accuracy of AI-Generated Emotion Identification at T1
時間枠：Immediately post-intervention at 4 weeks (T1)
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AI emotion recognition accuracy will be evaluated by comparing AI-generated emotion identification results with expert ratings.
Accuracy will be reported as the proportion of correctly identified emotional states.
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Immediately post-intervention at 4 weeks (T1)
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Participant Acceptability of AI-Integrated Emotional Granularity Growth (AI-EGG)
時間枠：Immediately post-intervention (T1)
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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.
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Immediately post-intervention (T1)
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- HSEARS20260427001
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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結腸直腸がん（CRC）の臨床試験
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Shanghai Henlius Biotechまだ募集していません
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Niguarda HospitalUniversity of Turin, Italy; Fondazione del Piemonte per l'Oncologia完了
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Chang Gung Memorial HospitalFBD Biologics Limited募集
Emotional granularity trainingの臨床試験
-
University of MinnesotaNational Institute of Mental Health (NIMH)完了精神病性障害 | 統合失調症 | 統合失調症スペクトラムおよびその他の精神病性障害 | 統合失調感情障害 | 精神病 | 統合失調感情障害 | 統合失調症性障害 | 精神病、感情的 | 精神性気分障害 | 精神病患者番号/その他アメリカ
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VA Office of Research and Development募集
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University of WashingtonNational Institute on Aging (NIA); Kaiser Permanente完了