Clinical trial NCT06492993: Community Health Navigator Program to Promote Cancer Screenings Among DDBHH People
Official title: Community Health Navigator Program to Promote Cancer Screenings Among Deaf, Deafblind, and Hard of Hearing Adults Who Use American Sign Language
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cancer
Deafness
Lead sponsor: Gallaudet University
Sponsor class: OTHER
First posted: 2024-07-09
Enrollment: 200
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Number of participants who are adherent to cancer screening
timeFrame: 9 months
Secondary outcomes:
measure: Percent of participants who demonstrate high cancer knowledge and high perceived patient centered care
timeFrame: 9 months
Other outcomes:
Locations:
city: Washington
country: United States
facility: Gallaudet University
state: District of Columbia
Study officials:
affiliation: Gallaudet University
name: Poorna Kushalnagar
role: PRINCIPAL_INVESTIGATOR
References: