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
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Joyce Oi Kwan Chung, PhD
- 电话号码：852-27666322
- 邮箱：okjoyce.chung@polyu.edu.hk
学习地点
-
-
Jiangsu
-
Kunshan、Jiangsu、中国、215300
- Kunshan First People's Hospital Affiliated to Jiangsu University
-
接触：
- Juan Song, MSN
- 电话号码：86-13913274133
- 邮箱：93930739@qq.com
-
Suzhou、Jiangsu、中国、215000
- The Second Affiliated Hospital of Soochow University
-
接触：
- Li Tian, PhD
- 电话号码：86-13862596317
- 邮箱：tianlisz@suda.edu.cn
-
Suzhu、Jiangsu、中国、215000
- The First Affiliated Hospital of Soochow University
-
接触：
- Li Tian, PhD
- 电话号码：86-13862596317
- 邮箱：tianlisz@suda.edu.cn
-
-
参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
|
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
其他名称：
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.
|
|
有源比较器：Control group
Participants in the control group will receive routine psychological care provided by oncology nurses.
|
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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Recruitment Rate
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Resilience Measured by the Chinese Version of the 10-item Connor-Davidson Resilience Scale (CD-RISC-10)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Participant Acceptability of AI-Integrated Emotional Granularity Growth (AI-EGG)
大体时间：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
大体时间：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)
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- HSEARS20260427001
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.