A Stepped Care Intervention to Reduce Disparities in Mental Health Services Among Cancer Patients and Caregivers
A Stepped-Care Intervention to Reduce Disparities in Mental Health Services Among Underserved Lung and Head and Neck Cancer Patients and Their Caregivers
2 other identifiers
interventional
535
1 country
5
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2017
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 27, 2016
CompletedFirst Posted
Study publicly available on registry
January 10, 2017
CompletedStudy Start
First participant enrolled
April 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 17, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 17, 2020
CompletedResults Posted
Study results publicly available
March 19, 2021
CompletedMarch 19, 2021
February 1, 2021
3.3 years
December 27, 2016
November 2, 2020
February 24, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
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
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
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 Outcomes (7)
Change in Coping-Caregivers
6-months
Symptoms of Anxiety-Caregivers
6-months
Symptoms of Depression-Caregivers
6-months
Health-Related Quality of Life-Patients
6-months
Perceived Stress-Patients
6-months
- +2 more secondary outcomes
Study Arms (2)
Stepped-Care Intervention
EXPERIMENTALIntervention 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.
Enhanced Usual Care
ACTIVE COMPARATORDenver 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.
Interventions
The intervention delivered evidence-based CBT and stress management across eight counseling sessions.
Consists of a list of standard mental health resources offered at the participating hospital, local community, or national non-profit organizations.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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:
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Denver Health Medical Center
Denver, Colorado, 80204, United States
University of Colorado Denver
Denver, Colorado, 80204, United States
National Jewish Health
Denver, Colorado, 80206, United States
Saint Joseph Hospital
Denver, Colorado, 80218, United States
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, 81502, United States
Related Publications (1)
Borrayo EA, Juarez-Colunga E, Kilbourn K, Waxmonsky J, Jacobson M, Okuyama S, Swaney R, Wamboldt FS, Karam S, Lopez Alvarez S, Jin X, Nguyen J. Stepped-care to improve mental health outcomes among underserved patients with lung and head and neck cancer. Psychooncology. 2023 Nov;32(11):1718-1726. doi: 10.1002/pon.6223. Epub 2023 Sep 29.
PMID: 37772984DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Evelinn Borrayo, Associate Director
- Organization
- Latino Research and Policy Center, University of Colorado Denver
Study Officials
- PRINCIPAL INVESTIGATOR
Evelinn A Borrayo, PhD
University of Colorado, Denver
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 27, 2016
First Posted
January 10, 2017
Study Start
April 3, 2017
Primary Completion
July 17, 2020
Study Completion
July 17, 2020
Last Updated
March 19, 2021
Results First Posted
March 19, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share