NCT07452055

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. 1.Does the intervention improve health-related quality of life (EORTC QLQ-C30 summary score) at 6 months post-intervention?
  2. 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.
  3. 3.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.
  4. 4.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.
  5. 5.For all participants, report any adverse events and unplanned hospitalizations during the study period.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
440

participants targeted

Target at P75+ for not_applicable

Timeline
6mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress25%
Mar 2026Nov 2026

First Submitted

Initial submission to the registry

February 23, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 5, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

March 10, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

7 months

First QC Date

February 23, 2026

Last Update Submit

March 10, 2026

Conditions

Primary Breast Cancer

Keywords

Large language modelEmotional managementHealth-related quality of life

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Health-related quality of life

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

  • 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

  • +1 more secondary outcomes

Study Arms (2)

APP Managemengt Group

EXPERIMENTAL

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

usual care

ACTIVE COMPARATOR

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

Interventions

Large Language Model-Based precision emotional intervention systemBEHAVIORAL

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.

APP Managemengt Group
Usual Care GroupBEHAVIORAL

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.

usual care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, China

Location

Central Study Contacts

Yanni Wu

CONTACT

020-61641192yanniwuSMU@126.com

Meiqin Luo

CONTACT

2016851232@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2026

First Posted

March 5, 2026

Study Start

March 10, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

March 12, 2026

Record last verified: 2026-03

Locations

CN(1)