Active — Not RecruitingNot Applicable

Large Language Model-Based Emotional Management for Breast Cancer Patients

China440 participantsStarted 2026-03-24

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Health-related quality of life (EORTC QLQ-C30 summary score)

Timeframe: Baseline and at 1st, 3rd and 6th months after intervention

Trial details

NCT IDNCT07452055

SponsorNanfang Hospital, Southern Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11-30

View on ClinicalTrials.gov More Primary Breast Cancer trials