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

NCT07262632 | Recruiting

• 2 other identifiers: 11388MEC-2024-0601
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Cancer-related Pain; Pain assessment; Artificial Intelligence (AI); Oncology; Oncology Pain; Database; Facial Action Unit; Vocalizations; Acoustic; Automatic assessment; Machine learning; Audiovisual data; Paralinguistics

Outcome Measures

Primary Outcomes (1)

• Audiovisual recordings of facial and vocal pain expression

  The main endpoint consists of audiovisual recordings of each patient's face (from the shoulders up) and voice while the patient reads a short standardised sentence and describes their pain experience. Recordings (maximum 60 seconds after filtering for relevant parts) will be stored digitally and used as input data for the training and validation of an AI-based pain assessment algorithm.

  Up to 2 weeks

Secondary Outcomes (2)

• Clinical and patient-reported parameters from electronic health records

  At each recording session

• Patient-reported mood and pain questionnaire outcomes

  During each recording session

Study Arms (2)

Pain Group

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.

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

Control Group

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.

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

Interventions

Audiovisual and questionnaire-based data collection (consecutive) OTHER

Participants will be video recorded for up to 60 seconds from the shoulders up while reading a short sentence and describing their pain or daily experience. They will also complete a brief questionnaire about their mood and how they express pain. No drugs, medical devices, or clinical treatments are used. This non-invasive data collection is performed on several consecutive days during admission for participants with pain.

Also known as: Video recording procedure, Mood questionnaire, Pain questionnaire

Pain Group

Audiovisual and questionnaire-based data collection (once) OTHER

Participants will be video recorded for up to 60 seconds from the shoulders up while reading a short sentence and describing their pain or daily experience. They will also complete a brief questionnaire about their mood and how they express pain. No drugs, medical devices, or clinical treatments are used. This non-invasive data collection is performed once for participants without pain.

Also known as: Video recording procedure, Mood questionnaire, Pain questionnaire

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Hospitalised adult cancer patients recruited from the oncology and palliative care departments of Erasmus University Medical Center (Erasmus MC) in Rotterdam, the Netherlands. The study includes both patients admitted for cancer-related pain and those admitted for treatment without pain. Participants represent an inpatient clinical population from a tertiary referral centre, providing a controlled setting for audiovisual and clinical data collection.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Mark Mulder: lead
• Delft University of Technology: collaborator

Study Sites (1)

Erasmus University Medical Centre

Rotterdam, South Holland, 3015 GD, Netherlands

RECRUITING

MeSH Terms

Conditions

Cancer Pain; Neoplasms; Facial Expression; Vocalization, Animal

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nonverbal Communication; Communication; Behavior; Animal Communication; Behavior, Animal

Study Officials

• Mark Mulder, dr.ir.

  Erasmus University Medical Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marsha Kamsteeg, MSc

CONTACT

+31 107040704; m.kamsteeg@erasmusmc.nl

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 3, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The de-identified dataset containing extracted facial and vocal features, along with relevant clinical and demographic variables, will be made available after publication of the main study results and within 12 months of study completion. Data will remain accessible for at least 5 years after the initial release, or longer if there is continued scientific interest and compliance with privacy regulations.
• Access Criteria: Access to de-identified participant data and supporting materials will be granted to qualified academic researchers upon reasonable request. Interested researchers must submit a written proposal outlining their research objectives and analysis plan. Access will be provided only after approval of a data sharing agreement that ensures ethical use of the data and compliance with General Data Protection Regulation (GDPR) requirements. The original audiovisual recordings containing identifiable information will not be shared. Data will be made available through controlled access managed by the research team at Erasmus MC.

Locations

NL (1)