N/A
N=535
A Stepped Care Intervention to Reduce Disparities in Mental Health Services Among Cancer Patients and Caregivers
Cancer, Lung · Cancer, Head and Neck
Bottom Line
View on ClinicalTrials.gov: NCT03016403 ↗Enrolled (actual)
535
Serious AEs
6.2%
Results posted
Mar 2021
Primary outcome: Primary: Symptoms of Depression-Patients — 15.3; 13.2 score on a scale — p=0.0057
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Stepped-Care Intervention (Behavioral); Enhanced Usual Care (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Symptoms of Depression-Patients |
15.3; 13.2 | 0.0057 sig |
| PRIMARY Symptoms of Anxiety-Patients |
16.0; 13.9 | 0.0243 sig |
| PRIMARY Change in Coping-Patients |
190; 207 | 0.0061 sig |
| SECONDARY Change in Coping-Caregivers |
192; 211 | 0.21 |
| SECONDARY Symptoms of Anxiety-Caregivers |
17; 14 | 0.052 |
| SECONDARY Symptoms of Depression-Caregivers |
15.0; 13.2 | 0.214 |
| SECONDARY Health-Related Quality of Life-Patients |
73; 80 | 0.0134 sig |
| SECONDARY Perceived Stress-Patients |
14; 13 | 0.42 |
| SECONDARY Perceived Stress-Caregivers |
15; 11 | 0.0269 sig |
| SECONDARY Caregiving Burden-Caregivers |
13; 9 | 0.0044 sig |
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
- 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:
- 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.
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.
- 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:
- cognitive or personality impairment,
- suicidal ideation, or
- 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:
- vulnerable populations (e.g., inmates or individuals on probation, homeless,
- pregnant women, and
- those with auditory impairment [at the discretion of the Site Coordinators upon recruitment]).
- Individuals who become pregnant or develop auditory impairments after they have been randomized to study condition may remain in the study until completion.
Data sourced from ClinicalTrials.gov (NCT03016403). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.