A Stepped Care Intervention to Reduce Disparities in Mental Health Services Among Cancer Patients and Caregivers
Completed · Not applicable
Conditions studied: Cancer, Lung, Cancer, Head and Neck
In brief
Medically under-served (i.e., low-income, uninsured, underinsured) cancer patients generally encounter significant disparities in accessing care for their mental health needs while undergoing toxic treatments that provide considerable physical and emotional stress. Thus, the investigators propose to adapt evidence-based strategies to a stepped-care intervention model to address the mental health needs of under-served lung cancer (LC) and head and neck cancer (HNC) patients and their caregivers across several levels of symptom severity (e.g., mild, moderate, or severe symptoms of depression and anxiety).
Key facts
- Study ID
- NCT03016403
- Run by
- University of Colorado, Denver
- People needed
- 535
- Starts
- 2017-04-03
- Expected to finish
- 2020-07-17
- Last updated by the study team
- 2021-03-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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:
- Low-income: Below 400% of the 2016 Federal poverty levels;
- Uninsured: No health insurance (public or private insurance);
- 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.
You may not qualify if…
- 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.
- 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:
- Low-income: Below 400% of the 2016 Federal poverty levels;
- Uninsured: No health insurance (public or private insurance);
- 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:
Where it is running
- Denver Health Medical Center — Denver, Colorado, United States
- University of Colorado Denver — Denver, Colorado, United States
- National Jewish Health — Denver, Colorado, United States
- Saint Joseph Hospital — Denver, Colorado, United States
- Saint Mary's Hospital and Regional Medical Center — Grand Junction, Colorado, United States
Full record on ClinicalTrials.gov
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