Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2025-12-24 @ 7:46 PM
NCT ID:
NCT03016403
Eligibility Criteria:
1. LC and HNC patients:
Inclusion Criteria:
* Newly diagnosed LC and/or HNC (within a month of recruitment date from the date of 1st visit oncology, Ear Nose and Throat (ENT), or radiation clinic visit/consultation upon pathologic tissue diagnosis;
* LC and/or HNC patients at any stage of diagnosis (Stages 0-IV);
* Over 18 years old;
* English and/or Spanish speaking;
* Medically underserved, as defined by at least one or several of the following:
1. Low-income: Below 400% of the 2016 Federal poverty levels;
2. Uninsured: No health insurance (public or private insurance);
3. Underinsured: e.g.: Public insurance (Medicaid, Medicare exclusive, VA); and/or 10% of annual income on out-of-pocket medical expenses for individuals below 200% of the 2016 Federal poverty levels.
Exclusion Criteria:
* Individuals who do not meet eligibility criteria, including individuals who do not speak English or Spanish;
* Those who refuse treatment at one of three hospital sites;
* Decisionally-challenged adults with cognitive or personality impairment;
* Suicidal ideation, or
* Intoxication (alcohol or drugs) that might interfere with their ability to consent or participate in the study;
* Individuals from vulnerable populations (e.g., inmates or individuals on probation,
* homeless,
* pregnant women, and
* those with auditory impairment.
Note: Individuals who become pregnant or develop auditory impairments after they have been randomized to study condition may remain in the study until completion.
2. Caregivers of LC and/or HNC patients
Inclusion Criteria:
* Primary caregiver of a newly diagnosed LC and/or HNC patient (per criteria for patients);
* Over 18 years old;
* English and/or Spanish speaking;
* Medically underserved, as defined by at least one or several of the following:
1. Low-income: Below 400% of the 2016 Federal poverty levels;
2. Uninsured: No health insurance (public or private insurance);
3. Underinsured:
* (c.1) Public insurance (i.e., Medicaid, Medicare exclusive, VA);
* (c.2) 10% of annual income spent on out-of-pocket medical expenses for individuals below 200% of the 2016 Federal poverty level.
Exclusion criteria:
* Individuals who do not meet eligibility criteria, including individuals who do not speak English or Spanish \[at the discretion of the Site Coordinators upon recruitment\];
* Caregivers of patients who refuse treatment at one of three hospital sites.
* Decisionally challenged adults with:
1. cognitive or personality impairment,
2. suicidal ideation, or
3. intoxication (alcohol or drugs) that might interfere with their ability to consent or participate in the study \[at the discretion of the Site Coordinators upon recruitment or the Counselor during the intervention\];
* Individuals from:
1. vulnerable populations (e.g., inmates or individuals on probation, homeless,
2. pregnant women, and
3. those with auditory impairment \[at the discretion of the Site Coordinators upon recruitment\]).
4. Individuals who become pregnant or develop auditory impairments after they have been randomized to study condition may remain in the study until completion.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03016403
Study Brief:
Protocol Section:
NCT03016403