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

Not Applicable

Completed

• Conditions: Cancer, Head and Neck; Cancer, Lung

• Registration Number: NCT03016403
• Lead Sponsor: University of Colorado, Denver

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-27
• Study First Submitted QC: 2017-01-06
• Study First Posted: 2017-01-10
• Study Start: 2017-04-03
• Primary Completion: 2020-07-17
• Study Completion: 2020-07-17
• Results First Submitted: 2020-11-02
• Status Verified: 2021-02
• Results First Submitted QC: 2021-02-24
• Last Update Submitted: 2021-02-24
• Results First Posted: 2021-03-19
• Last Update Posted: 2021-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 535

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Coping-Patients	6-months	Coping Self-Efficacy (26 items). Scores can rage from 0 to 260. Higher score corresponds to better outcome.
Symptoms of Anxiety-Patients	6-months	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.
Symptoms of Depression-Patients	6-months	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.

Secondary Outcome Measures

Name	Time	Method
Change in Coping-Caregivers	6-months	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.
Health-Related Quality of Life-Patients	6-months	FACT-G version 4 (27 items). The range is 0-108. Higher values indicate better QOL.
Perceived Stress-Patients	6-months	Perceived Stress Scale (PSS) (14 items). The range of scores is 0-40. Higher values indicate higher stress.
Perceived Stress-Caregivers	6-months	Perceived Stress Scale (PSS) (14 items). The range is from 0 to 40. Higher values indicate higher stress.
Symptoms of Depression-Caregivers	6-months	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.
Caregiving Burden-Caregivers	6-months	Zarit Burden Interview (ZBI) (12 items). The range of scores is 0-48. Higher scores represent higher burden.
Symptoms of Anxiety-Caregivers	6-months	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.

Trial Locations

Locations (5)

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