Clinical trial NCT03016403: A Stepped Care Intervention to Reduce Disparities in Mental Health Services Among Cancer Patients and Caregivers
Official title: A Stepped-Care Intervention to Reduce Disparities in Mental Health Services Among Underserved Lung and Head and Neck Cancer Patients and Their Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer, Lung
Cancer, Head and Neck
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2017-01-10
Enrollment: 535
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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).


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.

Primary outcomes:
measure: Symptoms of Depression-Patients
timeFrame: 6-months
measure: Symptoms of Anxiety-Patients
timeFrame: 6-months
measure: Change in Coping-Patients
timeFrame: 6-months
Secondary outcomes:
measure: Change in Coping-Caregivers
timeFrame: 6-months
measure: Symptoms of Anxiety-Caregivers
timeFrame: 6-months
measure: Symptoms of Depression-Caregivers
timeFrame: 6-months
measure: Health-Related Quality of Life-Patients
timeFrame: 6-months
measure: Perceived Stress-Patients
timeFrame: 6-months
measure: Perceived Stress-Caregivers
timeFrame: 6-months
measure: Caregiving Burden-Caregivers
timeFrame: 6-months
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health Medical Center
state: Colorado
city: Denver
country: United States
facility: University of Colorado Denver
state: Colorado
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Denver
country: United States
facility: Saint Joseph Hospital
state: Colorado
city: Grand Junction
country: United States
facility: Saint Mary's Hospital and Regional Medical Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Evelinn A Borrayo, PhD
role: PRINCIPAL_INVESTIGATOR
References: