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

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ClinicalTrials.gov Identifier: NCT03016403
Recruitment Status : Recruiting
First Posted : January 10, 2017
Last Update Posted : May 10, 2018
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Cancer, Lung Cancer, Head and Neck Behavioral: Stepped-Care Intervention Behavioral: Enhanced Usual Care Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : March 24, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Stepped-Care Intervention
Intervention strategies are grounded in evidence-based Cognitive Behavioral Therapy (CBT), that includes stress management and relaxation treatment strategies and coping skills training. Treatment strategies have been adapted from the Transactional Model of Stress and Coping (TMSC), a theoretical model that predicts that individuals who are able to cope and adapt to the stress related to cancer treatment or caregiving will report less psychological distress than those unable to cope.
Behavioral: Stepped-Care Intervention
The intervention delivered evidence-based CBT and stress management across eight counseling sessions.

Active Comparator: Enhanced Usual Care
Denver Health, St. Mary's and St. Joseph's hospitals provide supportive mental health care for patients such as printed materials, support groups, crisis counseling, and specialized care (e.g., psychiatric medication). Because the amount of usual mental health care that each patient receives varies at each site, the investigators will standardize and monitor the usual care arm across the three sites with an enhanced usual care condition.
Behavioral: Enhanced Usual Care
Consists of a list of standard mental health resources offered at the participating hospital, local community, or national non-profit organizations.
Other Name: Standard of Care




Primary Outcome Measures :
  1. Change in Symptoms of Depression-Patients [ Time Frame: Baseline, 6-weeks, 3-months and 6-months ]
    Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer (CA) Form v1.0 - Depression (30 items)

  2. Change in Symptoms of Depression-Caregivers [ Time Frame: Baseline, 6-weeks, 3-months and 6-months ]
    PROMIS Form v1.0 - Depression (28 items)

  3. Change in Symptoms of Anxiety-Patients [ Time Frame: Baseline, 6-weeks, 3-months and 6-months ]
    PROMIS-Ca Form v1.0- Anxiety (22 items)

  4. Change in Symptoms of Anxiety-Caregivers [ Time Frame: Baseline, 6-weeks, 3-months and 6-months ]
    PROMIS Form v1.0 - Anxiety (29 items)

  5. Change in Coping-Patients [ Time Frame: Baseline, 6-weeks, 3-months and 6-months ]
    Coping Self-Efficacy (26 items)

  6. Change in Coping-Caregivers [ Time Frame: Baseline, 6-weeks, 3-months and 6-months ]
    Coping Self-Efficacy (26 items)


Secondary Outcome Measures :
  1. Change in Health-Related Quality of Life-Patients [ Time Frame: Baseline, 6-weeks, 3-months and 6-months ]
    FACT-Lung Cancer version 4 (36 items)

  2. Change in Perceived Stress-Patients [ Time Frame: Baseline, 6-weeks, 3-months and 6-months ]
    Perceived Stress Scale (PSS) (14 items)

  3. Change in Perceived Stress-Caregivers [ Time Frame: Baseline, 6-weeks, 3-months and 6-months ]
    Perceived Stress Scale (PSS) (14 items)

  4. Change in Caregiving Burden-Caregivers [ Time Frame: Baseline, 6-weeks, 3-months and 6-months ]
    Zarit Burden Interview (ZBI) (12 items)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03016403


Contacts
Contact: Alice A Bradley, MA 303-315-2514 alice.bradley@ucdenver.edu

Locations
United States, Colorado
University of Colorado Denver Recruiting
Denver, Colorado, United States, 80204
Contact: Alice A Bradley, MA    303-315-2514    alice.bradley@ucdenver.edu   
Contact: Suzell Klein, MA    303-315-2517    Suzell.Klein@ucdenver.edu   
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Evelinn A Borrayo, PhD University of Colorado, Denver

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03016403     History of Changes
Other Study ID Numbers: 16-2621
AD-1511-33395 ( Other Grant/Funding Number: PCORI )
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases