Community Health Navigator Program to Promote Cancer Screenings Among DDBHH People

NCT ID: NCT06492993

Last Updated: 2024-07-19

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-30
• Study Completion Date: 2026-08-31

Brief Summary

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.

Conditions

Cancer; Deafness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

Intervention

CHN provides educational sessions with patients at time points.

Group Type: EXPERIMENTAL

Education

Intervention Type: OTHER

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

Standard of Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Education

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gallaudet University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Poorna Kushalnagar

Role: PRINCIPAL_INVESTIGATOR

Gallaudet University

Locations

Gallaudet University

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

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40925603 (View on PubMed)

Other Identifiers

CDHE

Identifier Type: -

Identifier Source: org_study_id