Using Community Health Navigators to Advance Cancer Screening Adherence

NCT06492993 | Completed

• 1 other identifier: IRB-FY21-120
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief Summary

Intervention to promote cancer screenings among deaf, deafblind, and hard of hearing participants who have not received screening within the recommended guideline.

Conditions

Cancer; Deafness

Outcome Measures

Primary Outcomes (1)

• 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

  9 months

Secondary Outcomes (1)

• Percent of participants who demonstrate high cancer knowledge and high perceived patient centered care

  9 months

Study Arms (2)

Intervention

EXPERIMENTAL

CHN provides educational sessions with patients at time points.

Other: Education

Standard of Care

NO INTERVENTION

Standard of care to inform participant about the screening recommendations and check ins.

Interventions

Education OTHER

The CHN meets with DDBHH participant over sessions to provide navigation support through the cancer screening process.

Intervention

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gallaudet University: lead

Study Sites (1)

Gallaudet University

Washington D.C., District of Columbia, 20002, United States

Location

Related Publications (1)

• 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.

  PMID: 40925603 DERIVED

MeSH Terms

Conditions

Neoplasms; Deafness

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Poorna Kushalnagar

  Gallaudet University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 9, 2024
• Study Start: September 30, 2023
• Primary Completion: March 20, 2026
• Study Completion: March 20, 2026
• Last Updated: April 2, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)