CancerNCT06492993
Using Community Health Navigators to Advance Cancer Screening Adherence
A study testing Education in people with Cancer and Deafness, run by Gallaudet University at 1 site in United States.
Trial summary
Intervention to promote cancer screenings among deaf, deafblind, and hard of hearing participants who have not received screening within the recommended guideline. Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- What is being tested?
- Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2023to 20 Mar 2026
- Phase
- Interventional
- 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 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and lifestyle considerations (see Section 5.3, Lifestyle Considerations) and availability for the duration of the study
- Male or female at birth age 45-80yo or female at birth age 45-80yo; age-eligible according to screening criteria
- Self-reported diagnosis of bilateral hearing loss at birth or prior to 13 years old (defined as "early deafness") and use ASL
- Willingness to adhere to the CHN clinical trial regimen
- Willingness to provide cancer screening verification documentation; this will be reviewed during the informed consent procedure
- Access to necessary resources to support video-based communication
- Non-adherent to one or more cancer screening guidelines for breast, lung, prostate, colon, cervical cancers will be those who reported not having had the appropriate recommended screenings within the past year to cancer screening questions in the HINTS-ASL survey
Who cannot join
- Presence of full ability to hear in one or both ears beyond 13 years of age
- Younger or older than the age cutoff for the recommended cancer screening
- Not capable of independently conducting the activities of daily living
- In compliance with age- or risk-specific screening at the time of evaluation for study eligibility
- Are currently undergoing cancer treatment or being evaluated for the presence of cancer at the time of evaluation for study eligibility
- Will be engaged in more than 21 consecutive days of travel during the eleven-month study window
- Knows other participants at baseline
Trial locations and contacts
1 site in 1 country.
United States1 site
Gallaudet University
Washington D.C., District of Columbia, 20002
About this study
Official title: Using Community Health Navigators to Advance Cancer Screening Adherence Through Videoconferencing for All Americans Who Use ASL: A Randomized Controlled Trial Study
Intervention to promote cancer screenings among deaf, deafblind, and hard of hearing participants who have not received screening within the recommended guideline.
Read the detailed description
Study hypothesizes that the intervention that involves utilization of a DDBHH CHN will result in (i) DDBHH patients demonstrating greater adherence to screening compared to DDBHH patients who were assigned to the standard of care group , and (ii) higher patient-physician communication rating by DDBHH patients compared to DDBHH patients who were assigned to the standard of care group. Bilingual ASL-English measures (e.g., sociodemographics, cancer knowledge, patient-physician communication) will be administered to the participant at baseline data collection and again after the final data collection or by 11 months for comparison.
- Being tested
- Education
- Medical subject headings
- Neoplasms, Deafness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
The CHN meets with DDBHH participant over sessions to provide navigation support through the cancer screening process.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | CHN provides educational sessions with patients at time points. Receives: Other: Education |
| Standard of Care | No intervention | Standard of care to inform participant about the screening recommendations and check ins. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who are adherent to cancer screening
Completion of at least one recommended cancer screening as measured by documentation of the actual screening
Measured: 9 months
Secondary outcomes (1)
Percent of participants who demonstrate high cancer knowledge and high perceived patient centered care
Positive change in patient-physician communication and cancer knowledge from baseline to closeout as defined by the participating patient.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start30 Sep 2023
- Primary completion20 Mar 2026
- Study completion20 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gallaudet University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Poorna Kushalnagar, Principal investigator, Gallaudet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06492993
- Sponsor's protocol ID
- IRB-FY21-120
- Status last verified
- Jul 2025
- First submitted
- 27 Jun 2024
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kushalnagar P, Rao SR, Bergeron E, Valdez R, Wang R, Kushalnagar RS, Sadler GR. Using American Sign Language-Fluent Community Health Navigators to Advance Cancer Screening Adherence through Videoconferencing With Deaf, Deafblind, and Hard of Hearing Adults: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Sep 9;14:e65078. doi: 10.2196/65078.
PubMed 40925603
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Community Health Navigators to Advance Cancer Screening Adherence Through Videoconferencing for All Americans Who Use ASL: A Randomized Controlled Trial Study
- ClinicalTrials.gov ID
- NCT06492993
- Acronym / sponsor ID
- IRB-FY21-120
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Gallaudet UniversityUniversity, hospital or other
- Study start
- 30 Sep 2023 (actual)
- Primary completion
- 20 Mar 2026 (actual)
- Study completion
- 20 Mar 2026 (actual)
- First posted
- 9 Jul 2024 (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.
Intervention to promote cancer screenings among deaf, deafblind, and hard of hearing participants who have not received screening within the recommended guideline.
Detailed description
Study hypothesizes that the intervention that involves utilization of a DDBHH CHN will result in (i) DDBHH patients demonstrating greater adherence to screening compared to DDBHH patients who were assigned to the standard of care group , and (ii) higher patient-physician communication rating by DDBHH patients compared to DDBHH patients who were assigned to the standard of care group. Bilingual ASL-English measures (e.g., sociodemographics, cancer knowledge, patient-physician communication) will be administered to the participant at baseline data collection and again after the final data collection or by 11 months for comparison.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: EducationCHN provides educational sessions with patients at time points. |
| Standard of Care | No intervention | –Standard of care to inform participant about the screening recommendations and check ins. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and lifestyle considerations (see Section 5.3, Lifestyle Considerations) and availability for the duration of the study
- Male or female at birth age 45-80yo or female at birth age 45-80yo; age-eligible according to screening criteria
- Self-reported diagnosis of bilateral hearing loss at birth or prior to 13 years old (defined as "early deafness") and use ASL
- Willingness to adhere to the CHN clinical trial regimen
Key exclusion criteria (7 listed)
- Presence of full ability to hear in one or both ears beyond 13 years of age
- Younger or older than the age cutoff for the recommended cancer screening
- Not capable of independently conducting the activities of daily living
- In compliance with age- or risk-specific screening at the time of evaluation for study eligibility
- Are currently undergoing cancer treatment or being evaluated for the presence of cancer at the time of evaluation for study eligibility
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 |
|---|---|---|
| EducationThe CHN meets with DDBHH participant over sessions to provide navigation support through the cancer screening process. | Other | Intervention |
Primary outcome
Number of participants who are adherent to cancer screening
Time frame: 9 months
Completion of at least one recommended cancer screening as measured by documentation of the actual screening
1 secondary outcome
Percent of participants who demonstrate high cancer knowledge and high perceived patient centered care
Time frame: 9 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 2 Apr 2026.
- Derived from this study: PubMed 40925603Kushalnagar P, Rao SR, Bergeron E, Valdez R, Wang R, Kushalnagar RS, Sadler GR. Using American Sign Language-Fluent Community Health Navigators to Advance Cancer Screening Adherence through Videoconferencing With Deaf, Deafblind, and Hard of Hearing Adults: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Sep 9;14:e65078. doi: 10.2196/65078.
- Individual participant dataSharing planned: No
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
Poorna Kushalnagar principal investigator
Gallaudet University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Cancer and Deafness, run by Gallaudet University 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 8 inclusion and 7 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 2 Apr 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?
Number of participants who are adherent to cancer screening (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06492993, which also lists 1 linked publication.
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 2 Apr 2026.