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Trial Title: Community Health Navigator Program to Promote Cancer Screenings Among DDBHH People

NCT ID: NCT06492993

Condition: Cancer
Deafness

Conditions: Official terms:
Deafness

Study type: Interventional

Study phase: N/A

Overall status: Enrolling by invitation

Study design:

Allocation: Randomized

Intervention model: Crossover Assignment

Primary purpose: Screening

Masking: Single (Participant)

Intervention:

Intervention type: Other
Intervention name: Education
Description: The CHN meets with DDBHH participant over sessions to provide navigation support through the cancer screening process.
Arm group label: Intervention

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.

Criteria for 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

Gender: All

Minimum age: 45 Years

Maximum age: 80 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Gallaudet University

Address:
City: Washington
Zip: 20002
Country: United States

Start date: September 30, 2023

Completion date: August 31, 2026

Lead sponsor:
Agency: Gallaudet University
Agency class: Other

Source: Gallaudet University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06492993

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