Primary Breast CancerEMBRACENCT07452055
Large Language Model-Based Emotional Management for Breast Cancer Patients
A study testing Large Language Model-Based precision emotional intervention system in people with Primary Breast Cancer, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Breast Cancer
- What is being tested?
- Large Language Model-Based precision emotional intervention system
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 1 siteChina
- Study dates
- 24 Mar 2026to 20 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
- Does the intervention improve health-related quality of life (EORTC QLQ-C30 summary score) at 6 months post-intervention?
- 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:
- 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.
- 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.
- For all participants, report any adverse events and unplanned hospitalizations during the study period.
- Conditions
- Primary Breast Cancer
- Being tested
- Large Language Model-Based precision emotional intervention system, Usual Care Group
- Keywords
- Large language model, Emotional management, Health-related quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Large Language Model-Based precision emotional intervention systemBehavioural
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.
Usual Care GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Usual Care Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and at 1st, 3rd and 6th months after intervention
Secondary outcomes (6)
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).
Measured: Baseline and at 1st, 3rd and 6th months after intervention
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 7 days after the intervention ended after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start24 Mar 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Breast CancerStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07452055
- Sponsor's protocol ID
- NFEC-2026-035
- Acronym
- EMBRACE
- Status last verified
- Sep 2026
- First submitted
- 23 Feb 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that underlie the results reported in the primary publication will be made available to qualified researchers upon reasonable request, subject to applicable ethical and institutional requirements, data protection regulations, and approval of a methodologically sound research proposal. Requests will be considered provided that the proposed use does not conflict with ongoing or planned analyses by the original investigators. A data use agreement may be required. The study protocol and statistical analysis plan are publicly available through the ClinicalTrials.gov registration.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Large Language Model-Based Emotional Management for Breast Cancer Patients: A Multi-center, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT07452055
- Acronym / sponsor ID
- EMBRACE / NFEC-2026-035
- Conditions
- Primary Breast Cancer
- Keywords
- Large language model, Emotional management, Health-related quality of life
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 24 Mar 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does the intervention improve health-related quality of life (EORTC QLQ-C30 summary score) at 6 months post-intervention?
- 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:
- 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.
- 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.
- For all participants, report any adverse events and unplanned hospitalizations during the study period.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APP Managemengt Group | Experimental | Behavioral: Large Language Model-Based precision emotional intervention systemThis 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. |
| usual care | Active comparator | Behavioral: Usual Care GroupParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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);
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Large Language Model-Based precision emotional intervention systemThis 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. | Behavioural | APP Managemengt Group |
| Usual Care GroupParticipants 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. | Behavioural | usual care |
Primary outcome
Health-related quality of life (EORTC QLQ-C30 summary score)
Time frame: Baseline and at 1st, 3rd and 6th months after intervention
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.
6 secondary outcomes
Health-related quality of life
Time frame: Baseline and at 1st, 3rd and 6th months after intervention
Anxiety
Time frame: Baseline and at 1st, 3rd and 6th months after intervention
Depression
Time frame: Baseline and at 1st, 3rd and 6th months after intervention
Cancer-related symptom burden
Time frame: Baseline and at 1st, 3rd and 6th months after intervention
Unplanned hospitalization rate
Time frame: Within 7 days after the intervention ended after 6 months
Time to first unplanned hospitalization
Time frame: Within 7 days after the intervention ended after 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data that underlie the results reported in the primary publication will be made available to qualified researchers upon reasonable request, subject to applicable ethical and institutional requirements, data protection regulations, and approval of a methodologically sound research proposal. Requests will be considered provided that the proposed use does not conflict with ongoing or planned analyses by the original investigators. A data use agreement may be required. The study protocol and statistical analysis plan are publicly available through the ClinicalTrials.gov registration.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Large Language Model-Based precision emotional intervention system in people with Primary Breast Cancer, run by Nanfang Hospital, Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related quality of life (EORTC QLQ-C30 summary score) (time frame: Baseline and at 1st, 3rd and 6th months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.