A Stepped Care Intervention to Reduce Disparities in Mental Health Services Among Cancer Patients and Caregivers

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.