Large Language Model-Based Emotional Management for Breast Cancer Patients

Large Language Model-Based Emotional Management for Breast Cancer Patients: A Multi-center, Randomized, Controlled Trial

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:

1. Does the intervention improve health-related quality of life (EORTC QLQ-C30 summary score) at 6 months post-intervention?
2. 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:

1. 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.
2. 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.
3. For all participants, report any adverse events and unplanned hospitalizations during the study period.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.