Skin CancerDP-SKINNCT07670403
Digital Phenotyping of Psychological Distress in Skin Cancer Patients
An observational study of Skin Cancer and Melanoma (Skin Cancer), run by West China Hospital at 1 site in China.
Trial summary
This prospective observational study enrolls 500 skin cancer patients across five Chinese tertiary care centers. The investigators use natural language processing and a hierarchical transformer model to analyse 1.2 million social media posts (Weibo, Douyin, Xiaohongshu, WeChat) for psychological distress and suicide… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Skin Cancer, Melanoma (Skin Cancer), Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 1 Jun 2026
- Phase
- Observational
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Skin cancer patients experience high rates of anxiety and depression, yet routine screening is inconsistent. This study collects social media content from 500 patients over 24 months (12 months retrospective + 12 months prospective).
Who may be able to join
- Age ≥ 18 years
- Histologically confirmed skin cancer within the preceding 60 months
- Active user of at least one target social media platform (Weibo, Douyin, Xiaohongshu, or WeChat Channels)
- Willingness to provide informed consent for social media data collection
- Ability to read and write in Chinese
Who cannot join
- Pre-existing major psychiatric disorder diagnosed prior to cancer diagnosis
- Cognitive impairment preventing informed consent
- Inability to access social media accounts
- Concurrent participation in other digital mental health interventions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Digital Phenotyping of Psychological Distress in Skin Cancer Patients: A Transformer-Based Analysis of Chinese Social Media Content
This prospective observational study enrolls 500 skin cancer patients across five Chinese tertiary care centers. The investigators use natural language processing and a hierarchical transformer model to analyse 1.2 million social media posts (Weibo, Douyin, Xiaohongshu, WeChat) for psychological distress and suicide ideation, with prospective validation of an AI Early Warning System.
Read the detailed description
Skin cancer patients experience high rates of anxiety and depression, yet routine screening is inconsistent. This study collects social media content from 500 patients over 24 months (12 months retrospective + 12 months prospective). Linguistic markers are identified using a custom Skin Cancer Linguistic Inquiry and Word Count (SC-LIWC) dictionary developed through expert consensus. A hierarchical transformer network with multi-head self-attention is built, comprising word-level (RoBERTa-wwm-ext), post-level (BiGRU+attention), and user-level (8-head self-attention) encoders with platform embeddings to address cross-platform heterogeneity. The model predicts suicide ideation risk (C-SSRS score ≥2) within 12 months, achieving AUC=0.91 in validation. An AI Early Warning System (EWS) is prospectively tested: alerts are triggered at threshold 0.38, reviewed by psychologists (12.4 min/alert), and interventions (crisis hotline, online counselling, psychoeducational materials) are automatically delivered. All data collection complies with China's Personal Information Protection Law (PIPL) and uses a 5-layer de-identification protocol (direct identifier removal, SHA-256 hashing, NER redaction, timestamp shifting, role-based access control). The study also examines cross-platform performance, optimal observation windows, and false-positive patterns to guide refinement
- Conditions
- Skin Cancer, Melanoma (Skin Cancer), Squamous Cell Carcinoma Head and Neck Cancer (HNSCC), Basal Cell Carcinoma of Skin
- Keywords
- digital phenotyping; psychological distress; social media; natural language processing; transformer; suicide prevention; psycho-oncology
- Medical subject headings
- Skin Neoplasms, Melanoma, Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Basal Cell, Suicide Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| cancer patients across five Chinese tertiary care centers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Suicide Ideation Risk Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Proportion of participants with C-SSRS score ≥ 2 (active suicidal ideation with some intent to act, without specific plan) at any follow-up assessment. The C-SSRS is a clinician-administered instrument with a severity subscale ranging from 0 (no suicidal ideation) to 5 (active suicidal ideation with specific plan and intent). Higher scores indicate greater suicide risk.
Measured: 24 months
Secondary outcomes (4)
Depression Severity Assessed by the Patient Health Questionnaire-9 (PHQ-9)
Mean change in PHQ-9 total score from baseline to each follow-up assessment. The PHQ-9 is a 9-item self-report questionnaire measuring depressive symptoms over the past 2 weeks. Total scores range from 0 to 27, with higher scores indicating greater depression severity (moderate-to-severe: ≥10).
Measured: 24 months
Anxiety Severity Assessed by the Generalized Anxiety Disorder-7 (GAD-7)
Mean change in GAD-7 total score from baseline to each follow-up assessment. The GAD-7 is a 7-item self-report questionnaire measuring generalized anxiety symptoms over the past 2 weeks. Total scores range from 0 to 21, with higher scores indicating greater anxiety severity (moderate-to-severe: ≥10).
Measured: 24 months
Psychological Distress Assessed by the Hospital Anxiety and Depression Scale (HADS)
Mean change in HADS total score (sum of Anxiety and Depression subscales) from baseline to each follow-up assessment. The HADS is a 14-item self-report questionnaire with two 7-item subscales (Anxiety and Depression), each ranging from 0 to 21. Higher subscale scores indicate worse psychological distress (subscale ≥15 indicates clinically significant distress).
Measured: 24 months
Rate of Psychological Resource Utilization Following AI Early Warning System Alerts
Proportion of high-risk participants (C-SSRS ≥ 2) who access at least one psychological resource (crisis hotline, online counseling link, or psychoeducational material) following an automated alert from the AI Early Warning System, compared to a matched historical control group (pre-EWS period).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start1 Jan 2024
- Primary completion30 Dec 2025
- Study completion1 Jun 2026
Why it stopped: poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin CancerStudies of the same condition, open and under way.
- More trials run by West China HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhigang Lan, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07670403
- Sponsor's protocol ID
- WestChinaH-HX-2026-003
- Acronym
- DP-SKIN
- Status last verified
- Oct 2026
- First submitted
- 17 Jun 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes