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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDr. Mark Mulder

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Adult patients (≥18 years)

Diagnosed with cancer, active

Able to communicate verbally in Dutch or English

Able to provide written informed consent.

Disqualifiers

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 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Audiovisual and questionnaire-based data collection (once)

    Other intervention

    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.

  • Audiovisual and questionnaire-based data collection (consecutive)

    Other intervention

    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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Pain Group1 intervention
Group B: Control Group1 intervention

Trial outcomes

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.

Time frame
Up to 2 weeks

Secondary outcomes

1

Clinical and patient-reported parameters from electronic health records

Secondary data used to label the audiovisual recordings and provide context for model development, including patient-reported pain intensity (NRS 0-10), patient-reported change in pain (increasing, decreasing, no change), patient description of pain (short annotations), quality of life (if reported), observer-reported pain intensity (NRS 0-10), analgesics in use (drug name, dose, frequency), cancer tumour type, stage, Karnofsky score, and current treatment, demographics: age, sex, height, weight

Time frame
At each recording session
2

Patient-reported mood and pain questionnaire outcomes

Assessment of patients' self-reported mood and perceived pain expression using a short questionnaire administered alongside audiovisual recordings. The questionnaire evaluates: current mood state, perceived intensity and expressiveness of pain, ease or difficulty in expressing pain verbally and non-verbally. Responses will be used to explore associations between subjective reports and multimodal AI-derived pain indicators.

Time frame
During each recording session

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dr. Mark Mulder

Lead sponsor

Erasmus Medical Center

Sponsor institution

Delft University of Technology

Collaborator