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Life sciences · Interventional Study
ClinicalTrials.gov · September 22, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07452055). This is a study registration, not published results. Lead sponsor: Nanfang Hospital, Southern Medical University. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 440 participants (ESTIMATED). Conditions: Primary Breast Cancer. Interventions: BEHAVIORAL: Large Language Model-Based precision emotional intervention system; BEHAVIORAL: Usual Care Group. Primary outcome measures: Health-related quality of life (EORTC QLQ-C30 summary score) , Baseline and at 1st, 3rd and 6th months after intervention. Brief summary: 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.