Large Language Model-Based Emotional Management for Breast Cancer Patients (EMBRACE)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Primary Breast Cancer
• Intervention / Treatment: Behavioral: Large Language Model-Based precision emotional intervention system; Behavioral: Usual Care Group

• Study Type: Interventional
• Enrollment (Estimated): 440
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yanni Wu; Phone Number: 020-61641192; Email: yanniwuSMU@126.com
• Study Contact Backup: Name: Meiqin Luo; Email: 2016851232@qq.com

Study Locations

• China
  • Guangzhou, China
    • Nanfang Hospital, Southern Medical University
    • Contact: Yanni Wu; Phone Number: 020-61641192; Email: yanniwuSMU@126.com
    • Contact: Meiqin Luo; Email: 2016851232@qq.com
    • Principal Investigator: Meiqin Luo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Large Language Model-Based precision emotional intervention system; 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.
Active Comparator: 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.	Behavioral: Usual Care Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related quality of life (EORTC QLQ-C30 summary score)	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.	Baseline and at 1st, 3rd and 6th months after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	The Generalized Anxiety Disorder Scale (GAD-7) was used, consisting of 7 items, to assess the degree to which patients were troubled by anxiety-related symptoms such as tension, worry, and difficulty in relaxation over the past 2 weeks; the total score of this scale ranges from 0 to 21, with higher scores indicating more significant emotional symptoms.	Baseline and at 1st, 3rd and 6th months after intervention
Depression	The Patient Health Questionnaire-9 (PHQ-9) was used, which consists of 9 items and has a total score ranging from 0 to 27. The higher the score, the more significant the emotional symptoms are.	Baseline and at 1st, 3rd and 6th months after intervention
Cancer-related symptom burden	Each symptom score is calculated as the mean of frequency, severity, and distress ratings (range 0-4), with absent symptoms scored as zero. Higher MSAS scores indicate greater symptom burden.	Baseline and at 1st, 3rd and 6th months after intervention
Unplanned hospitalization rate	The unplanned hospitalization rate is defined as the ratio of the total number of unplanned hospitalization events to the total number of person-months in the study cohort, and is expressed as the number of events per person-month. Unplanned hospitalization is defined as admission via emergency or urgent care. Planned hospitalizations for the purposes of chemotherapy or radiotherapy (ICD-9 codes: V58.0, V58.1, V58.11, V58.12) and rehabilitation (ICD-9 codes: V57.xx) are excluded. When the admission type is unknown, hospitalizations with emergency department charges greater than zero are classified as unplanned hospitalizations; otherwise, they are categorized as other hospitalizations.	Within 7 days after the intervention ended after 6 months
Time to first unplanned hospitalization	Time from the date of randomization to the occurrence of the first unplanned hospitalization event.	Within 7 days after the intervention ended after 6 months
Health-related quality of life	The EORTC QLQ-C30 questionnaire comprises 15 dimensions, including five functional domains (physical, role, emotional, cognitive, and social functioning), three symptom domains (fatigue, pain, and nausea/vomiting), one Global Health Status/Quality of Life domain, and six single-item symptom scales (e.g., dyspnea, insomnia). Scoring is performed by first calculating the mean of the raw scores for each domain or item, which is then linearly transformed into a standardized 0-100 score using the formula (mean raw score-1)/range of response options×100. For the functional domains and the Global Health Status/Quality of Life domain, higher scores indicate better functioning or quality of life (positive scoring), whereas for the symptom domains, higher scores indicate greater symptom severity and poorer health status (negative scoring).	Baseline and at 1st, 3rd and 6th months after intervention

Collaborators and Investigators

• Sponsor: Nanfang Hospital, Southern Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): March 10, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: February 23, 2026
• First Submitted That Met QC Criteria: February 27, 2026
• First Posted (Actual): March 5, 2026

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Health-related quality of life; Large language model; Emotional management
• Other Study ID Numbers: NFEC-2026-035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The individual patient data sharing plan has not yet been finalized. The research team will make a decision on whether and how to share the data after the completion of the main study, based on the guidance of the ethics committee, relevant laws and regulations requirements, and the results of the data security assessment.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No