Using Community Health Navigators to Advance Cancer Screening Adherence

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.

Study Overview

• Status: Completed
• Conditions: Cancer; Deafness
• Intervention / Treatment: Other: Education

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 Type: Interventional
• Enrollment (Actual): 184
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20002
      • Gallaudet University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; CHN provides educational sessions with patients at time points.	Other: Education; The CHN meets with DDBHH participant over sessions to provide navigation support through the cancer screening process.
No Intervention: Standard of Care; Standard of care to inform participant about the screening recommendations and check ins.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	9 months

Collaborators and Investigators

• Sponsor: Gallaudet University
• Investigators: Principal Investigator: Poorna Kushalnagar, Gallaudet University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2023
• Primary Completion (Actual): March 20, 2026
• Study Completion (Actual): March 20, 2026

Study Registration Dates

• First Submitted: June 27, 2024
• First Submitted That Met QC Criteria: July 2, 2024
• First Posted (Actual): July 9, 2024

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 28, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Loss; Hearing Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neoplasms; Deafness; Socioeconomic Factors; Population Characteristics; Educational Status
• Other Study ID Numbers: IRB-FY21-120

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No