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Completed

NCT Number: NCT03016403

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Denver Health Medical Center, Denver, Colorado, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

Stepped-Care Intervention

Behavioral

The intervention delivered evidence-based CBT and stress management across eight counseling sessions.

Enhanced Usual Care

Behavioral

Consists of a list of standard mental health resources offered at the participating hospital, local community, or national non-profit organizations.

Other names: Standard of Care

Primary outcomes

  1. Symptoms of Depression-Patients

    Time frame: 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.

  2. Symptoms of Anxiety-Patients

    Time frame: 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.

  3. Change in Coping-Patients

    Time frame: 6-months

    Coping Self-Efficacy (26 items). Scores can rage from 0 to 260. Higher score corresponds to better outcome.

Secondary outcomes

  1. Change in Coping-Caregivers

    Time frame: 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.

  2. Symptoms of Anxiety-Caregivers

    Time frame: 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.

  3. Symptoms of Depression-Caregivers

    Time frame: 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.

  4. Health-Related Quality of Life-Patients

    Time frame: 6-months

    FACT-G version 4 (27 items). The range is 0-108. Higher values indicate better QOL.

  5. Perceived Stress-Patients

    Time frame: 6-months

    Perceived Stress Scale (PSS) (14 items). The range of scores is 0-40. Higher values indicate higher stress.

  6. Perceived Stress-Caregivers

    Time frame: 6-months

    Perceived Stress Scale (PSS) (14 items). The range is from 0 to 40. Higher values indicate higher stress.

  7. Caregiving Burden-Caregivers

    Time frame: 6-months

    Zarit Burden Interview (ZBI) (12 items). The range of scores is 0-48. Higher scores represent higher burden.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

A Stepped-Care Intervention to Reduce Disparities in Mental Health Services Among Underserved Lung and Head and Neck Cancer Patients and Their Caregivers

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jan 10, 2017
Registry last updated
Mar 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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