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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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.
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 groups in NCT04442425
Study groupRoleWhat they receive
1DF/NoPain_IV-VI_FemaleWorst pain in past month = 0; Skin Type IV-VI, Female
1DM/NoPain_IV-VI_MaleWorst pain in past month = 0; Skin Type IV-VI, Male
1LF/NoPain_I-III_FemaleWorst pain in past month = 0; Skin Type I-III, Female
1LM/NoPain_I-III_MaleWorst pain in past month = 0; Skin Type I-III, Male
2DF/MildPain_IV-VI_FemaleWorst pain in past month = 1-3; Skin Type IV-VI, Female
2DM/MildPain_IV-VI_MaleWorst pain in past month = 1-3; Skin Type IV-VI, Male
2LF/MildPain_I-III_FemaleWorst pain in past month = 1-3; Skin Type I-III, Female
2LM/MildPain_I-III_MaleWorst pain in past month = 1-3; Skin Type I-III, Male
3DF/ModPain_IV-VI_FemaleWorst pain in past month = 4-6; Skin Type IV-VI, Female
3DM/ModPain_IV-VI_MaleWorst pain in past month = 4-6; Skin Type IV-VI, Male
3LF/ModPain_I-III_FemaleWorst pain in past month = 4-6; Skin Type I-III, Female
3LM/ModPain_I-III_MaleWorst pain in past month = 4-6; Skin Type I-III, Male
4DF/SeverePain_IV-VI_FemaleWorst pain in past month = 7-10; Skin Type IV-VI, Female
4DM/SeverePain_IV-VI_MaleWorst pain in past month = 7-10; Skin Type IV-VI, Male
4LF/SeverePain_I-III_FemaleWorst pain in past month = 7-10; Skin Type I-III, Female
4LM/SeverePain_I-III_MaleWorst 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.

  1. 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)
  1. To determine the feasibility of using voice recognition technology

    Voice recognition technology

    Measured: 3 months

  2. To transcribe patient video responses to assess pain using free-text

    Video responses to assess pain using free-text

    Measured: 3 months

  3. To determine the feasibility of combining RGB and thermal images with voice recognition transcribed verbal responses

    RGB and thermal images

    Measured: 3 months

  4. 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.

  1. First posted22 Jun 2020
  2. Study start27 Oct 2020
  3. Primary completion27 Mar 2024
  4. Study completion27 Mar 2024

Resources

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)
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.

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.

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