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Protocol Details

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

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

20-C-0130

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 12 Years
Max Age: 120 Years

Referral Letter Required

No

Population Exclusion(s)

Non-English Speaking

Keywords

Telehealth;
Self-Reported Pain;
Facial Recognition Technology;
Pain Score;
Natural History

Recruitment Keyword(s)

None

Condition(s)

Cancer;
Neoplasms;
Solid Tumors

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Cancer Institute

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 gender 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.

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Eligibility

INCLUSION CRITERIA:

1. Ability of subject to understand and willingness to sign a written informed consent document.

2. Adults and children (including NIH staff) aged >= 12 years.

3. Participants with diagnosis of a cancer or tumor

4. Participant must be receiving either standard of care or investigational cancer/tumor treatment either at NIH or with a community physician.

5. 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.

EXCLUSION CRITERIA:

1. 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.

2. Participants with Parkinson s disease.

3. Known current alcohol or drug abuse.

4. Any psychiatric condition that would prohibit the understanding or rendering of informed consent.

5. Non-English speaking subjects.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

James L. Gulley, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CLINICAL CENTER BG RM 13N240C
10 CENTER DR
BETHESDA MD 20892
(301) 480-7164
gulleyj@mail.nih.gov

Elizabeth A. Lamping
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 13N222
10 Center Drive
Bethesda, Maryland 20892
(240) 760-7966
lampingea@mail.nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937
ncimo_referrals@mail.nih.gov

Clinical Trials Number:

NCT04442425

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