Developing a Multimodal Cancer Pain Database to Support AI-Based Automatic Pain Assessment (SENSAI-DBD)

Dr. Mark Mulder

Status: Not yet enrolling

Conditions: Pain Assessment; Voice; Oncology; Cancer-related Pain; Oncology Pain; Database; Cancer; Facial Expression; Artificial Intelligence (AI)

Treatments: Other: Audiovisual and questionnaire-based data collection (once); Other: Audiovisual and questionnaire-based data collection (consecutive)

Study type: Observational

Funder types: Other

Identifiers

NCT07262632

11388

MEC-2024-0601 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

Pain Group

Description:

Adults (18 years and older) with active cancer who are admitted to the oncology ward for cancer-related pain. Participants will be recorded on video (from the shoulders up) for up to 60 seconds while reading a short sentence and describing their pain experience. They will also complete a short questionnaire about their mood and pain expression. Audiovisual data and selected clinical information (such as pain scores and medications) will be collected from their medical record. Participants may be recorded on several consecutive days during admission.

Treatment:

Other: Audiovisual and questionnaire-based data collection (consecutive)

Control Group

Description:

Adults (18 years and older) with active cancer who are admitted to the oncology ward for chemotherapy and report no pain (Numerical Rating Scale score = 0). Participants will be recorded on video (from the shoulders up) for up to 60 seconds while reading a short sentence and describing their daily experience. They will also complete a short questionnaire about their mood and pain expression. Only one recording will be made for each participant.

Treatment:

Other: Audiovisual and questionnaire-based data collection (once)