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Recruiting NCT07262632

NCT07262632 Developing a Multimodal Cancer Pain Database to Support AI-Based Automatic Pain Assessment

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Clinical Trial Summary
NCT ID NCT07262632
Status Recruiting
Phase
Sponsor Dr. Mark Mulder
Condition Cancer-related Pain
Study Type OBSERVATIONAL
Enrollment 200 participants
Start Date 2025-12-01
Primary Completion 2027-12-31

Trial Parameters

Condition Cancer-related Pain
Sponsor Dr. Mark Mulder
Study Type OBSERVATIONAL
Phase N/A
Enrollment 200
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-12-01
Completion 2027-12-31
Interventions
Audiovisual and questionnaire-based data collection (once)Audiovisual and questionnaire-based data collection (consecutive)

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Brief Summary

The goal of this observational study is to collect short video and sound recordings of people with cancer to create a secure database that can be used in future research to develop an artificial intelligence (AI) tool for pain assessment. The main aim is to build a large, high-quality collection of audiovisual data showing how people with cancer express themselves when they do and do not have pain. Participants will include adults with cancer who are admitted to the oncology ward for pain treatment and a control group admitted for chemotherapy who have no pain. After giving consent, participants will: * Be recorded on video (from the shoulders up) for up to 60 seconds while reading a short sentence and describing their pain or daily experience. * Complete a short questionnaire about their mood and pain expression. * Allow researchers to collect some information from their medical record, such as their pain score, medications, and cancer type. These recordings will be securely stored and used to create a database for future AI research. No medical tests, new treatments, or extra hospital visits are involved. This study will provide the foundation for developing future AI-based tools that could support doctors and patients in monitoring and managing pain more accurately and easily.

Eligibility Criteria

Inclusion Criteria: * Adult patients (≥18 years) * Diagnosed with cancer, active * Able to communicate verbally in Dutch or English * Able to provide written informed consent. * Pain group specific: * Experiencing pain related to cancer * Admitted to the hospital due to pain * Control group specific: * Not experiencing pain (NRS = 0) * Admitted to the hospital for chemotherapy Exclusion Criteria: * Cognitive, physical, or medical limitations that prevent participation in the audiovisual recording sessions or affect facial expressions or voice (e.g. facial paralysis, tracheostomy, severe speech impairment). * Critical illness or end-of-life care where participation would impose an additional burden. * Experiencing pain not associated with cancer * Infectious isolation precautions that prevent safe data collection

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