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

This is a prospective, single-centre database development study conducted at the Erasmus MC Cancer Institute. The purpose of the study is to create a high-quality audiovisual database for future research on automated pain assessment in people with cancer. The database will include short (up to 60 seconds) video and sound recordings of participants' facial and vocal expressions, alongside relevant clinical and demographic information.

The study will include two groups: (1) adults admitted to the oncology ward for cancer-related pain (pain group) and (2) adults admitted for chemotherapy who report no pain (control group). Participants will provide written informed consent before any recording takes place.

Each participant will be recorded from the shoulders up while reading a neutral prompt and, if applicable, describing their pain experience. The recordings will be securely stored in compliance with the General Data Protection Regulation (GDPR). In addition, researchers will collect secondary parameters from the participants' electronic medical record, such as pain scores, analgesic use, tumour type, and clinical status. Participants in the pain group may be recorded on multiple days during admission, while controls will be recorded once.

The audiovisual recordings will be used to extract facial and vocal features (e.g., Facial Action Units, voice parameters) with open-source software such as OpenFace and OpenSmile. These features will form the foundation for future artificial intelligence (AI) model development aimed at automatic pain assessment.

No experimental interventions, additional clinical procedures, or diagnostic tests are part of this study. The study carries minimal risk to participants, primarily related to the handling of identifiable audiovisual data. All data will be stored on Erasmus MC's secure Research Storage & Compute infrastructure, accessible only to authorised researchers.

The resulting dataset will be used to develop and validate AI models that can objectively estimate pain intensity from audiovisual data, supporting more accurate and continuous pain monitoring in clinical care.

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