Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Head and Neck Neoplasms

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

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.

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.

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

Stepped-Care Intervention

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

Enhanced Usual Care

Evelinn A Borrayo, PhD

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).

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

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.

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.

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

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.

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.

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.

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

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

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

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

University of Colorado, Denver

Patients who were randomized to Enhanced Usual Care

Patients in Enhanced Usual Care

Patients who were randomized to the Stepped Care Intervention

Patients in Stepped Care Intervention

Caregivers who were randomized to Enhanced Usual Care

Caregivers in Enhanced Usual Care

Caregivers who were randomized to the Stepped Care Intervention

Caregivers in Stepped Care Intervention

Total

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Language Preference

Diagnosis data were not collected from caregivers.

Diagnosis

Cancer Stage were clinically diagnosed by medical oncologists at each site and were self-reported by patients in the baseline survey. The cancer stages varied between stage 0, I, II, III, and IV with IV being the most advanced.

No cancer stage was collected from the caregivers.

Cancer Stage

The treatment steps that participants were assigned to, based on their personal level of distress included:

Step 1: Watchful Waiting Step 2: Self-Help Guide Step 3: Coping Skills Training Step 4: Cognitive-Behavioral Therapy

Step at Baseline

Evelinn Borrayo, Associate Director

A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.

Intention to treat population- all participants who were randomized were included in this analysis. The reported means correspond to the observed means at 6 months.

Symptoms of Depression-Patients

Linear mixed models (LMM) have been used with time and the interaction between time and group as fixed effects. A structure of random effects that includes random intercepts for patients was used. The study was powered for testing the hypothesis of no group differences in change over the four time points. A significant group by time interaction was hypothesized.

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

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.

Stepped-Care Intervention: The intervention delivered evidence-based CBT and stress management across eight counseling sessions.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Stepped Care Intervention to Reduce Disparities in Mental Health Services Among Cancer Patients and Caregivers	NCT03016403	Cancer, Lung Cancer, Head an...	Stepped-Care In... Enhanced Usual ...	18 Years -	University of Colorado, Denver
A Stepped Care Intervention to Reduce Disparities in Mental Health Services Among Cancer Patients and Caregivers	NCT03016403	Cancer, Lung Cancer, Head an...	Stepped-Care In... Enhanced Usual ...	18 Years -	University of Colorado, Denver

Spots Global Cancer Trial Database for cancer, head and neck