Large Language Model-Based Emotional Management for Breast Cancer Patients: A Multi-center, Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 440
- 试验地点
- 1
- 主要终点
- Health-related quality of life (EORTC QLQ-C30 summary score)
研究概览
简要总结
This study (study type: randomized controlled trial) aims to evaluate whether a large language model-based precision emotional management intervention can improve health-related quality of life among patients with primary breast cancer. The study will enroll adult women (≥18 years old) with pathologically confirmed primary breast cancer who own a smartphone, regularly use social media platforms, and have an expected survival of at least 6 months.
The primary questions this study seeks to answer are:
- Does the intervention improve health-related quality of life (EORTC QLQ-C30 summary score) at 6 months post-intervention?
- Does the intervention reduce anxiety, depression, cancer-related symptom burden, and unplanned hospitalizations in this population? With a control group in place, researchers will compare changes in health-related quality of life, anxiety, depression, and cancer-related symptom burden between the intervention group (receiving digital precision emotional management plus usual care) and the control group (receiving usual care only) to determine whether the intervention leads to significant improvements in these outcomes.
Participants will be required to:
- Complete baseline and follow-up assessments of health-related quality of life, anxiety, depression, and cancer-related symptoms at 1, 3, and 6 months post-randomization.
- For those in the intervention group, use the digital precision emotional management system autonomously for 6 months, including submitting self-reported emotional diaries and completing biweekly skill translation assessments.
- For all participants, report any adverse events and unplanned hospitalizations during the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of written informed consent;
- •Aged 18 years or over;
- •Histopathologically confirmed primary breast cancer;
- •Ownership of a smartphone and ability to independently operate the intervention system;
- •Regular use (at least three times per week) of one or more third-party social media platforms (e.g., Weibo, Douyin, or Xiaohongshu);
- •Clear consciousness, basic reading and writing ability (equivalent to primary education or above), and adequate communication capacity;
- •An estimated life expectancy of six months or longer, as assessed by the treating physician.
排除标准
- •Diagnosed with cognitive impairment or psychiatric disorders that substantially interfere with assessment or participation;
- •Pregnancy or lactation;
- •Presence of other malignant tumours, except for cured basal cell carcinoma of the skin or carcinoma in situ of the cervix, or severe organic disease (including cardiac, hepatic, or renal insufficiency);
- •Substance abuse (including alcohol or drug dependence) or current suicidal ideation;
- •Concurrent participation in other clinical trials or interventional studies that may interfere with outcome evaluation.
研究组 & 干预措施
APP Managemengt Group
This intervention is a digital precision emotional management system based on a large language model, classified as a behavioral intervention. The system automatically analyzes text data from social media and in-app platforms to detect six basic emotions (joy, anger, sadness, fear, disgust, and surprise) in near real-time, and generates personalized patient labels by integrating patients' physical symptoms. Leveraging an evidence-based knowledge base, the system delivers tailored strategies for emotion regulation and symptom management, including emotion management techniques, symptom relief recommendations, and health education content. Patients in the intervention group autonomously use this system for 6 months in addition to receiving usual care, and complete biweekly skill translation assessments to facilitate the application of intervention skills in daily life.
干预措施: Large Language Model-Based precision emotional intervention system (Behavioral)
usual care
Participants allocated to the control group receive usual emotional and symptom management for breast cancer, with no exposure to the digital intervention system. Standard care includes routine follow-up examinations, symptom management, psychological support, health education, and guidance on wound care, drainage tube management, diet, rest, and physical activity. All care is delivered in accordance with established clinical nursing procedures at the treating hospital.
During follow-up, participants experiencing severe psychological distress (e.g. suicidal ideation) are referred to psychiatric services in line with standard clinical practice. After completion of the trial, control-group participants are offered the option to access the intervention system voluntarily.
干预措施: Usual Care Group (Behavioral)
结局指标
主要结局
Health-related quality of life (EORTC QLQ-C30 summary score)
时间窗: Baseline and at 1st, 3rd and 6th months after intervention
In this study, the EORTC QLQ-C30 Summary Score is used as the primary analysis endpoint, and assessments are conducted using the Chinese version of the EORTC QLQ-C30 questionnaire. The EORTC QLQ-C30 Summary Score is calculated using the "13-domain mean method." Raw scores are first obtained from five functional scales and eight symptom scales, with all scores transformed to a 0-100 scale. All symptom scale scores are then reverse-scored, as higher original symptom scores indicate greater symptom burden; after transformation, higher scores uniformly indicate better outcomes, corresponding to milder symptoms. The arithmetic mean of the transformed scores across the 13 scales is subsequently calculated to generate the Summary Score, which remains on a 0-100 scale, with higher scores indicating better overall health-related quality of life.
次要结局
- Anxiety(Baseline and at 1st, 3rd and 6th months after intervention)
- Depression(Baseline and at 1st, 3rd and 6th months after intervention)
- Cancer-related symptom burden(Baseline and at 1st, 3rd and 6th months after intervention)
- Unplanned hospitalization rate(Within 7 days after the intervention ended after 6 months)
- Time to first unplanned hospitalization(Within 7 days after the intervention ended after 6 months)
- Health-related quality of life(Baseline and at 1st, 3rd and 6th months after intervention)