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

Cancer, Lung Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03016403
• Other study ID #: 16-2621.cc
• Secondary ID: AD-1511-33395
• Status: Completed
• Phase: N/A
• Start date: April 3, 2017
• Est. completion date: July 17, 2020

Study information

• Verified date: February 2021
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 535
• Est. completion date: July 17, 2020
• Est. primary completion date: July 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer, Head and Neck
• Cancer, Lung
• Lung Neoplasms

Intervention

Behavioral:
• Stepped-Care Intervention
The intervention delivered evidence-based CBT and stress management across eight counseling sessions.
• Enhanced Usual Care
Consists of a list of standard mental health resources offered at the participating hospital, local community, or national non-profit organizations.

Locations

Country	Name	City	State
United States	Denver Health Medical Center	Denver	Colorado
United States	National Jewish Health	Denver	Colorado
United States	Saint Joseph Hospital	Denver	Colorado
United States	University of Colorado Denver	Denver	Colorado
United States	Saint Mary's Hospital and Regional Medical Center	Grand Junction	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms of Depression-Patients	Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer (CA) Form v1.0 - Depression (30 items). The range is from 8 to 40. Higher score indicates worse outcome (higher depression). Raw scores were used in analyses.	6-months
Primary	Symptoms of Anxiety-Patients	Patient-Reported Outcomes Measurement Information System, Anxiety (PROMIS-Ca) Form v1.0- Anxiety (22 items). The range of scores is between 8 and 40. The raw scores were used. Higher score corresponds to worse outcome.	6-months
Primary	Change in Coping-Patients	Coping Self-Efficacy (26 items). Scores can rage from 0 to 260. Higher score corresponds to better outcome.	6-months
Secondary	Change in Coping-Caregivers	Coping Self-Efficacy (26 items). Higher score corresponds to better outcome. Scores can rage from 0 to 260.; The number of caregivers randomized and analyzed was 118 and 131 in the enhanced usual care and intervention groups, respectively.	6-months
Secondary	Symptoms of Anxiety-Caregivers	PROMIS Form v1.0 - Anxiety (29 items). The range of scores is from 8 to 40. Higher score indicates worse outcome (higher anxiety). Raw scores were used in analyses.; The number of caregivers randomized and analyzed was 118 and 131 in the enhanced usual care and intervention groups, respectively.	6-months
Secondary	Symptoms of Depression-Caregivers	PROMIS Form v1.0 - Depression (28 items). The range is from 8 to 40. Higher score indicates worse outcome (higher depression). Raw scores were used in analyses.; The number of caregivers randomized and analyzed was 118 and 131 in the enhanced usual care and intervention groups, respectively.	6-months
Secondary	Health-Related Quality of Life-Patients	FACT-G version 4 (27 items). The range is 0-108. Higher values indicate better QOL.	6-months
Secondary	Perceived Stress-Patients	Perceived Stress Scale (PSS) (14 items). The range of scores is 0-40. Higher values indicate higher stress.	6-months
Secondary	Perceived Stress-Caregivers	Perceived Stress Scale (PSS) (14 items). The range is from 0 to 40. Higher values indicate higher stress.	6-months
Secondary	Caregiving Burden-Caregivers	Zarit Burden Interview (ZBI) (12 items). The range of scores is 0-48. Higher scores represent higher burden.	6-months