Cancer-related PainSENSAI-DBDNCT07262632
Developing a Multimodal Cancer Pain Database to Support AI-Based Automatic Pain Assessment
An observational study of Cancer-related Pain and Pain Assessment, run by Dr. Mark Mulder at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer-related Pain, Pain Assessment, Artificial Intelligence (AI)
- What is being tested?
- Audiovisual and questionnaire-based data collection (once) and Audiovisual and questionnaire-based data collection (consecutive)
- How many people
- 200 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Dec 2025to 31 Dec 2027
- How long will I take part?
- 3 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 10Show fewer
- Admitted to the hospital due to pain
- Control group specific:
- Not experiencing pain (NRS = 0)
- Admitted to the hospital for chemotherapy
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus University Medical Centre
Rotterdam, South Holland, 3015 GD
Marsha Kamsteeg, MSc, +31 107040704, m.kamsteeg@erasmusmc.nl
m.kamsteeg@erasmusmc.nl
About this study
Official title: SENSAI: Seeing, hEaring, seNsing: Smart, Effortless and Objective Pain Assessment With Mobile AI Technology - DataBase Development
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:
Read more
- 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.
Read the detailed 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.
- Conditions
- Cancer-related Pain, Pain Assessment, Artificial Intelligence (AI), Oncology, Oncology Pain, Database
- Being tested
- Audiovisual and questionnaire-based data collection (once), Audiovisual and questionnaire-based data collection (consecutive)
- 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
- Medical subject headings
- Cancer Pain, Neoplasms, Facial Expression, Vocalization, Animal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audiovisual and questionnaire-based data collection (once)Other
Also called Video recording procedure, Mood questionnaire, Pain questionnaire
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
Also called Video recording procedure, Mood questionnaire, Pain questionnaire
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Audiovisual and questionnaire-based data collection (once) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 weeks
Secondary outcomes (2)
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
Measured: At each recording session
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.
Measured: During each recording session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start1 Dec 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer-related PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 3 Weeks
Sponsor and investigators
- Lead sponsor
- Dr. Mark Mulder
- Sponsor type
- University, hospital or other
- Collaborators
- Delft University of Technology
- Responsible party
- Sponsor-investigator, Dr. Mark Mulder, Erasmus Medical Center
- Investigators
- Mark Mulder, dr.ir., Principal investigator, Erasmus University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07262632
- Sponsor's protocol ID
- 11388
- Other IDs
- MEC-2024-0601
- Acronym
- SENSAI-DBD
- Status last verified
- Mar 2026
- First submitted
- 20 Nov 2025
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) in the form of non-identifiable, derived features will be shared for research purposes. The shared data will include automatically extracted facial and vocal features (e.g., facial action units, voice parameters) obtained from audiovisual recordings of participants, along with relevant clinical and demographic variables. The original audiovisual recordings will not be shared, as they contain identifiable information (faces and voices). Access to the derived dataset will be provided to qualified researchers upon reasonable request and after approval of a data sharing agreement that ensures compliance with privacy regulations, including the General Data Protection Regulation (GDPR). Data will be shared only for scientific and non-commercial research.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SENSAI: Seeing, hEaring, seNsing: Smart, Effortless and Objective Pain Assessment With Mobile AI Technology - DataBase Development
- ClinicalTrials.gov ID
- NCT07262632
- Acronym / sponsor ID
- SENSAI-DBD / 11388
- Conditions
- Cancer-related Pain, Pain Assessment, Artificial Intelligence (AI), Oncology, Oncology Pain, Database
- Keywords
- Cancer-related Pain, Pain assessment, Artificial Intelligence (AI), Oncology, Oncology Pain, Database, Facial Action Unit, Vocalizations
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Dr. Mark MulderUniversity, hospital or other
- Collaborators
- Delft University of Technology
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pain Group | – | Other: Audiovisual and questionnaire-based data collection (consecutive)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. |
| Control Group | – | Other: Audiovisual and questionnaire-based data collection (once)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Audiovisual and questionnaire-based data collection (once)Also: Video recording procedure, Mood questionnaire, Pain questionnaireParticipants 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. | Other | Control Group |
| Audiovisual and questionnaire-based data collection (consecutive)Also: Video recording procedure, Mood questionnaire, Pain questionnaireParticipants 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. | Other | Pain Group |
Primary outcome
Audiovisual recordings of facial and vocal pain expression
Time frame: Up to 2 weeks
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.
2 secondary outcomes
Clinical and patient-reported parameters from electronic health records
Time frame: At each recording session
Patient-reported mood and pain questionnaire outcomes
Time frame: During each recording session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) in the form of non-identifiable, derived features will be shared for research purposes. The shared data will include automatically extracted facial and vocal features (e.g., facial action units, voice parameters) obtained from audiovisual recordings of participants, along with relevant clinical and demographic variables. The original audiovisual recordings will not be shared, as they contain identifiable information (faces and voices). Access to the derived dataset will be provided to qualified researchers upon reasonable request and after approval of a data sharing agreement that ensures compliance with privacy regulations, including the General Data Protection Regulation (GDPR). Data will be shared only for scientific and non-commercial research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mark Mulder, dr.ir. principal investigator
Erasmus University Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer-related Pain and Pain Assessment, run by Dr. Mark Mulder at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marsha Kamsteeg, MSc (+31 107040704, m.kamsteeg@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Audiovisual recordings of facial and vocal pain expression (time frame: Up to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.