CancerNCT04442425
Machine Learning to Analyze Facial Imaging, Voice and Spoken Language for the Capture and Classification of Cancer/Tumor Pain
An observational study of Cancer and Neoplasms, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Cancer pain can have a very negative effect on people s daily lives. Researchers want to use machine learning to detect facial expressions and voice signals. They want to help people with cancer by creating a model to measure pain. They want the model to reflect diverse faces and facial expressions. Read more about this study
- Who is it for?
- Ages 12 to 120 years
- Conditions the study is for
- Cancer, Neoplasms, Solid Tumors
- Type of treatment
- Injection or infusion
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2020to 27 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 12 to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with histologically or cytologically proven cancer or tumor
Who may be able to join
- Ability of subject to understand and willingness to sign a written informed consent document.
- Adults and children (including NIH staff) aged >= 12 years.
- Participants with diagnosis of a cancer or tumor
- Participant must be receiving either standard of care or investigational cancer/tumor treatment either at NIH or with a community physician.
- Must have access to a smart phone (iPhone or Android) with either a data plan and/or access to wireless internet (wifi) or a computer with a camera and microphone and access to internet and must willing to use their device and assume any associated charges from
- service providers.
Who cannot join
- Participants with progressive brain tumors or metastasis. Participants with treated brain metastasis or primary brain tumor are eligible if there is no evidence of progression for at least 4 weeks after CNS directed treatment and there is no impact on voice or facial muscle movements.
- Participants with Parkinson s disease.
- Known current alcohol or drug abuse.
- Any psychiatric condition that would prohibit the understanding or rendering of informed consent.
- Non-English speaking subjects.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: A Feasibility Study Investigating the Use of Machine Learning to Analyze Facial Imaging, Voice and Spoken Language for the Capture and Classification of Cancer/Tumor Pain
Background:
Cancer pain can have a very negative effect on people s daily lives. Researchers want to use machine learning to detect facial expressions and voice signals. They want to help people with cancer by creating a model to measure pain. They want the model to reflect diverse faces and facial expressions.
Read more
Objective:
To find out whether facial recognition technology can be used to classify pain in a diverse set of people with cancer. Also, to find out whether voice recognition technology can be used to assess pain.
Eligibility:
People ages 12 and older who are undergoing treatment for cancer
Design:
Participants will be screened with:
Cancer history
Information about their sex and skin type
Information about their access to a smart phone and wireless internet
Questions about their cancer pain
Participants will have check-ins at the clinic and at home. These will occur over about 3 months. They will have 2-4 check-ins at the clinic. They will check in at home about 3 times per week.
During check-ins, participants will answer questions and talk about their cancer pain. They will use a mobile phone or a computer with a camera and microphone to complete a questionnaire. They will record a video of themselves reading a 15-second passage of text and responding to a question.
During the clinic check-ins, professional lighting, video equipment, and cameras will be used for the recordings.
During remote check-ins, participants will be asked to complete the questionnaire and recordings alone. They should be in a quiet and bright room. The room should have a white wall or background.
Read the detailed description
Background:
- Pain related to cancer/tumors can be widespread, wield debilitating effects on daily life, and interfere with otherwise positive outcomes from targeted treatment.
- The underpinnings of this study are chiefly motivated by the need to develop and validate objective methods for measuring pain using a model that is relevant in breadth and depth to a diversity of patient populations.
- Inadequate assessment and management of cancer/tumor pain can lead to functional and psychological deterioration and negatively impact quality of life.
- Research of objective measurement scales of pain based on automated detection of facial expression using machine learning is expanding but has been limited to certain demographic cohorts.
- Machine learning models demonstrate poor performance when training sets lack adequate diversity of training data, including visibly different faces and facial expressions, which yields opportunity in the proposed study to lay a guiding foundation by constructing a more general and generalizable model based on faces of varying sex and skin phototypes.
Objectives:
-The primary objective of this study is to determine the feasibility of using facial recognition technology to classify cancer/tumor related pain in a demographically diverse set of participants with cancer/tumors who are receiving standard of care or investigational treatment for their cancer/tumor.
Eligibility:
- Adults and children (12 years of age or older) with a diagnosis of a cancer or tumor who are receiving standard of care or investigational treatment for their underlying cancer/tumor.
- Participant must have access to internet connected smart phone or computer with camera and microphone and must be willing to pay any charges from service provider/carrier associated with the use of the device.
Design:
- The design is a single institution, observational, non-intervention clinical study at the National Institutes of Health Clinical Center.
- All participants will participate in the same activities in two different settings (remotely and in-clinic) for a three-month period.
- At home, participants will utilize a mobile application for self-reporting of pain and will audio- visually record themselves reading a passage of text and describing how they feel. In the clinic, participants will perform the same activities with optimal lighting and videography, along with infrared video capture.
- Visual (RGB) and infrared facial images, audio signal, self-reported pain and natural language verbalizations of participant feelings feel will be captured. Audio signal and video data will be annotated with self-reported pain and clinical data to create a supervised machine learning model that will learn to automatically detect pain.
- Care will be taken with the study sample to include a diversity of genders and skin types (a proxy for racial diversity) to establish a broad applicability of the model in the clinical setting. Additionally, video recordings of participant natural language to describe their pain and how they feel will be transcribed and auto-processed against the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PROCTCAE) library to explore the presence and progression of self-reporting of adverse events.
- Conditions
- Cancer, Neoplasms, Solid Tumors
- Keywords
- Telehealth, Self-Reported Pain, Facial Recognition Technology, Pain Score, Natural History
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1DF/NoPain_IV-VI_Female | Worst pain in past month = 0; Skin Type IV-VI, Female | |
| 1DM/NoPain_IV-VI_Male | Worst pain in past month = 0; Skin Type IV-VI, Male | |
| 1LF/NoPain_I-III_Female | Worst pain in past month = 0; Skin Type I-III, Female | |
| 1LM/NoPain_I-III_Male | Worst pain in past month = 0; Skin Type I-III, Male | |
| 2DF/MildPain_IV-VI_Female | Worst pain in past month = 1-3; Skin Type IV-VI, Female | |
| 2DM/MildPain_IV-VI_Male | Worst pain in past month = 1-3; Skin Type IV-VI, Male | |
| 2LF/MildPain_I-III_Female | Worst pain in past month = 1-3; Skin Type I-III, Female | |
| 2LM/MildPain_I-III_Male | Worst pain in past month = 1-3; Skin Type I-III, Male | |
| 3DF/ModPain_IV-VI_Female | Worst pain in past month = 4-6; Skin Type IV-VI, Female | |
| 3DM/ModPain_IV-VI_Male | Worst pain in past month = 4-6; Skin Type IV-VI, Male | |
| 3LF/ModPain_I-III_Female | Worst pain in past month = 4-6; Skin Type I-III, Female | |
| 3LM/ModPain_I-III_Male | Worst pain in past month = 4-6; Skin Type I-III, Male | |
| 4DF/SeverePain_IV-VI_Female | Worst pain in past month = 7-10; Skin Type IV-VI, Female | |
| 4DM/SeverePain_IV-VI_Male | Worst pain in past month = 7-10; Skin Type IV-VI, Male | |
| 4LF/SeverePain_I-III_Female | Worst pain in past month = 7-10; Skin Type I-III, Female | |
| 4LM/SeverePain_I-III_Male | Worst pain in past month = 7-10; Skin Type I-III, Male |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of using facial recognition technology to classify pain
The primary objective of this study is to determine the feasibility of using facial recognition technology to classify pain in a demographically diverse set of patients with cancer/tumor who are participating on a clinical trial.
Measured: 3 months
Secondary outcomes (4)
To determine the feasibility of using voice recognition technology
Voice recognition technology
Measured: 3 months
To transcribe patient video responses to assess pain using free-text
Video responses to assess pain using free-text
Measured: 3 months
To determine the feasibility of combining RGB and thermal images with voice recognition transcribed verbal responses
RGB and thermal images
Measured: 3 months
To use natural language processing algorithms to assess pain
Natural language processing algorithms to assess pain
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start27 Oct 2020
- Primary completion27 Mar 2024
- Study completion27 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- James L Gulley, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04442425
- Sponsor's protocol ID
- 200130
- Other IDs
- 20-C-0130
- Status last verified
- 29 Apr 2026
- First submitted
- 19 Jun 2020
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD recorded in the medical record will be shared with intramural investigators upon request.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study Investigating the Use of Machine Learning to Analyze Facial Imaging, Voice and Spoken Language for the Capture and Classification of Cancer/Tumor Pain
- ClinicalTrials.gov ID
- NCT04442425
- Acronym / sponsor ID
- 200130
- Conditions
- Cancer, Neoplasms, Solid Tumors
- Keywords
- Telehealth, Self-Reported Pain, Facial Recognition Technology, Pain Score, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 27 Oct 2020 (actual)
- Primary completion
- 27 Mar 2024 (actual)
- Study completion
- 27 Mar 2024 (actual)
- First posted
- 22 Jun 2020 (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.
Background:
Cancer pain can have a very negative effect on people s daily lives. Researchers want to use machine learning to detect facial expressions and voice signals. They want to help people with cancer by creating a model to measure pain. They want the model to reflect diverse faces and facial expressions.
Objective:
To find out whether facial recognition technology can be used to classify pain in a diverse set of people with cancer. Also, to find out whether voice recognition technology can be used to assess pain.
Eligibility:
People ages 12 and older who are undergoing treatment for cancer
Design:
Participants will be screened with:
Cancer history
Information about their sex and skin type
Information about their access to a smart phone and wireless internet
Questions about their cancer pain
Participants will have check-ins at the clinic and at home. These will occur over about 3 months. They will have 2-4 check-ins at the clinic. They will check in at home about 3 times per week.
During check-ins, participants will answer questions and talk about their cancer pain. They will use a mobile phone or a computer with a camera and microphone to complete a questionnaire. They will record a video of themselves reading a 15-second passage of text and responding to a question.
During the clinic check-ins, professional lighting, video equipment, and cameras will be used for the recordings.
During remote check-ins, participants will be asked to complete the questionnaire and recordings alone. They should be in a quiet and bright room. The room should have a white wall or background.
Detailed description
Background:
- Pain related to cancer/tumors can be widespread, wield debilitating effects on daily life, and interfere with otherwise positive outcomes from targeted treatment.
- The underpinnings of this study are chiefly motivated by the need to develop and validate objective methods for measuring pain using a model that is relevant in breadth and depth to a diversity of patient populations.
- Inadequate assessment and management of cancer/tumor pain can lead to functional and psychological deterioration and negatively impact quality of life.
- Research of objective measurement scales of pain based on automated detection of facial expression using machine learning is expanding but has been limited to certain demographic cohorts.
- Machine learning models demonstrate poor performance when training sets lack adequate diversity of training data, including visibly different faces and facial expressions, which yields opportunity in the proposed study to lay a guiding foundation by constructing a more general and generalizable model based on faces of varying sex and skin phototypes.
Objectives:
-The primary objective of this study is to determine the feasibility of using facial recognition technology to classify cancer/tumor related pain in a demographically diverse set of participants with cancer/tumors who are receiving standard of care or investigational treatment for their cancer/tumor.
Eligibility:
- Adults and children (12 years of age or older) with a diagnosis of a cancer or tumor who are receiving standard of care or investigational treatment for their underlying cancer/tumor.
- Participant must have access to internet connected smart phone or computer with camera and microphone and must be willing to pay any charges from service provider/carrier associated with the use of the device.
Design:
- The design is a single institution, observational, non-intervention clinical study at the National Institutes of Health Clinical Center.
- All participants will participate in the same activities in two different settings (remotely and in-clinic) for a three-month period.
- At home, participants will utilize a mobile application for self-reporting of pain and will audio- visually record themselves reading a passage of text and describing how they feel. In the clinic, participants will perform the same activities with optimal lighting and videography, along with infrared video capture.
- Visual (RGB) and infrared facial images, audio signal, self-reported pain and natural language verbalizations of participant feelings feel will be captured. Audio signal and video data will be annotated with self-reported pain and clinical data to create a supervised machine learning model that will learn to automatically detect pain.
- Care will be taken with the study sample to include a diversity of genders and skin types (a proxy for racial diversity) to establish a broad applicability of the model in the clinical setting. Additionally, video recordings of participant natural language to describe their pain and how they feel will be transcribed and auto-processed against the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PROCTCAE) library to explore the presence and progression of self-reporting of adverse events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| 1DF/NoPain_IV-VI_Female | – | –Worst pain in past month = 0; Skin Type IV-VI, Female |
| 1DM/NoPain_IV-VI_Male | – | –Worst pain in past month = 0; Skin Type IV-VI, Male |
| 1LF/NoPain_I-III_Female | – | –Worst pain in past month = 0; Skin Type I-III, Female |
| 1LM/NoPain_I-III_Male | – | –Worst pain in past month = 0; Skin Type I-III, Male |
| 2DF/MildPain_IV-VI_Female | – | –Worst pain in past month = 1-3; Skin Type IV-VI, Female |
| 2DM/MildPain_IV-VI_Male | – | –Worst pain in past month = 1-3; Skin Type IV-VI, Male |
| 2LF/MildPain_I-III_Female | – | –Worst pain in past month = 1-3; Skin Type I-III, Female |
| 2LM/MildPain_I-III_Male | – | –Worst pain in past month = 1-3; Skin Type I-III, Male |
| 3DF/ModPain_IV-VI_Female | – | –Worst pain in past month = 4-6; Skin Type IV-VI, Female |
| 3DM/ModPain_IV-VI_Male | – | –Worst pain in past month = 4-6; Skin Type IV-VI, Male |
| 3LF/ModPain_I-III_Female | – | –Worst pain in past month = 4-6; Skin Type I-III, Female |
| 3LM/ModPain_I-III_Male | – | –Worst pain in past month = 4-6; Skin Type I-III, Male |
| 4DF/SeverePain_IV-VI_Female | – | –Worst pain in past month = 7-10; Skin Type IV-VI, Female |
| 4DM/SeverePain_IV-VI_Male | – | –Worst pain in past month = 7-10; Skin Type IV-VI, Male |
| 4LF/SeverePain_I-III_Female | – | –Worst pain in past month = 7-10; Skin Type I-III, Female |
| 4LM/SeverePain_I-III_Male | – | –Worst pain in past month = 7-10; Skin Type I-III, Male |
Who may qualify
- Ages
- 12 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with histologically or cytologically proven cancer or tumor
Key inclusion criteria (6 listed)
- service providers.
Key exclusion criteria (5 listed)
- Participants with progressive brain tumors or metastasis. Participants with treated brain metastasis or primary brain tumor are eligible if there is no evidence of progression for at least 4 weeks after CNS directed treatment and there is no impact on voice or facial muscle movements.
- Participants with Parkinson s disease.
- Known current alcohol or drug abuse.
- Any psychiatric condition that would prohibit the understanding or rendering of informed consent.
- Non-English speaking subjects.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Feasibility of using facial recognition technology to classify pain
Time frame: 3 months
The primary objective of this study is to determine the feasibility of using facial recognition technology to classify pain in a demographically diverse set of patients with cancer/tumor who are participating on a clinical trial.
4 secondary outcomes
To determine the feasibility of using voice recognition technology
Time frame: 3 months
To transcribe patient video responses to assess pain using free-text
Time frame: 3 months
To determine the feasibility of combining RGB and thermal images with voice recognition transcribed verbal responses
Time frame: 3 months
To use natural language processing algorithms to assess pain
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD recorded in the medical record will be shared with intramural investigators upon request.
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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. This study is not recruiting at the moment.
James L Gulley, M.D. principal investigator
National Cancer Institute (NCI)
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 and Neoplasms, run by National Cancer Institute (NCI) at 1 site in United States.
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 26 Oct 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of using facial recognition technology to classify pain (time frame: 3 months). 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 26 Oct 2026.