Cancer, Head and Neck, Cancer, Lung
Conditions
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).
Interventions
BEHAVIORALStepped-Care Intervention
The intervention delivered evidence-based CBT and stress management across eight counseling sessions.
BEHAVIORALEnhanced Usual Care
Consists of a list of standard mental health resources offered at the participating hospital, local community, or national non-profit organizations.
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Change in Coping-Patients | 6-months | Coping Self-Efficacy (26 items). Scores can rage from 0 to 260. Higher score corresponds to better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Caregiving Burden-Caregivers | 6-months | Zarit Burden Interview (ZBI) (12 items). The range of scores is 0-48. Higher scores represent higher burden. |
| 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 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. |
| 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. |
Countries
United States
Participant flow
Recruitment details
Both patients and caregivers were recruited for this study. Primary outcomes data were focused on patients. Caregiver data were included as secondary analyses.
Participants by arm
| Arm | Count |
|---|---|
| Patients in Enhanced Usual Care Patients who were randomized to Enhanced Usual Care | 139 |
| Patients in Stepped Care Intervention Patients who were randomized to the Stepped Care Intervention | 147 |
| Caregivers in Enhanced Usual Care Caregivers who were randomized to Enhanced Usual Care | 118 |
| Caregivers in Stepped Care Intervention Caregivers who were randomized to the Stepped Care Intervention | 131 |
| Total | 535 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| 3-month Follow-up and 6-month Follow-up | Death | 6 | 4 | 0 | 0 |
| 3-month Follow-up and 6-month Follow-up | Lost to Follow-up | 6 | 7 | 8 | 6 |
| 3-month Follow-up and 6-month Follow-up | Withdrawal by Subject | 0 | 0 | 0 | 1 |
| 6-week Follow-up | Death | 1 | 4 | 0 | 0 |
| 6-week Follow-up | Lost to Follow-up | 2 | 7 | 4 | 8 |
| 6-week Follow-up | Withdrawal by Subject | 0 | 2 | 0 | 1 |
| Baseline | Death | 5 | 8 | 1 | 0 |
| Baseline | Lost to Follow-up | 9 | 11 | 6 | 24 |
| Baseline | Withdrawal by Subject | 2 | 8 | 4 | 10 |
Baseline characteristics
| Characteristic | Patients in Enhanced Usual Care | Total | Caregivers in Stepped Care Intervention | Caregivers in Enhanced Usual Care | Patients in Stepped Care Intervention |
|---|---|---|---|---|---|
| Age, Customized 18 to 65 | 65 Participants | 267 Participants | 69 Participants | 64 Participants | 69 Participants |
| Age, Customized Above 65 | 74 Participants | 221 Participants | 36 Participants | 33 Participants | 78 Participants |
| Age, Customized Under 18 | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Unknown or Not Report | 0 Participants | 47 Participants | 26 Participants | 21 Participants | 0 Participants |
| Cancer Stage Stage 0, I, & II | 65 Participants | 132 Participants | 0 Participants | 0 Participants | 67 Participants |
| Cancer Stage Stage III & IV | 73 Participants | 151 Participants | 0 Participants | 0 Participants | 78 Participants |
| Cancer Stage Unknown or Not Reported | 1 Participants | 3 Participants | 0 Participants | 0 Participants | 2 Participants |
| Diagnosis Head and neck cancer | 60 Participants | 120 Participants | 0 Participants | 0 Participants | 60 Participants |
| Diagnosis Lung cancer | 79 Participants | 166 Participants | 0 Participants | 0 Participants | 87 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 27 Participants | 126 Participants | 37 Participants | 28 Participants | 34 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 112 Participants | 408 Participants | 94 Participants | 89 Participants | 113 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Language Preference English | 133 Participants | 494 Participants | 118 Participants | 111 Participants | 132 Participants |
| Language Preference Spanish | 6 Participants | 41 Participants | 13 Participants | 7 Participants | 15 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 8 Participants | 3 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 13 Participants | 5 Participants | 6 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 25 Participants | 7 Participants | 3 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 7 Participants | 2 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 4 Participants | 0 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 27 Participants | 7 Participants | 4 Participants | 11 Participants |
| Race (NIH/OMB) White | 123 Participants | 451 Participants | 107 Participants | 99 Participants | 122 Participants |
| Region of Enrollment United States | 139 participants | 286 participants | 131 participants | 118 participants | 147 participants |
| Sex: Female, Male Female | 54 Participants | 310 Participants | 99 Participants | 92 Participants | 65 Participants |
| Sex: Female, Male Male | 85 Participants | 225 Participants | 32 Participants | 26 Participants | 82 Participants |
| Step at Baseline Step 1 & 2 | 106 Participants | 415 Participants | 106 Participants | 89 Participants | 114 Participants |
| Step at Baseline Step 3 & 4 | 33 Participants | 119 Participants | 25 Participants | 29 Participants | 32 Participants |
| Step at Baseline Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 13 / 139 | 18 / 147 | 1 / 118 | 0 / 131 |
| other Total, other adverse events | 0 / 139 | 0 / 147 | 0 / 118 | 0 / 131 |
| serious Total, serious adverse events | 13 / 139 | 19 / 147 | 1 / 118 | 0 / 131 |
Outcome results
Primary
Change in Coping-Patients
Coping Self-Efficacy (26 items). Scores can rage from 0 to 260. Higher score corresponds to better outcome.
Time frame: 6-months
Population: Intention to treat population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients in Enhanced Usual Care | Change in Coping-Patients | 190 score on a scale | Standard Deviation 55 |
| Patients in Stepped Care Intervention | Change in Coping-Patients | 207 score on a scale | Standard Deviation 54 |
Comparison: 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.p-value: 0.006195% CI: [-26.23, -4.39]Mixed Models Analysis
Primary
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.
Time frame: 6-months
Population: Intention to treat population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients in Enhanced Usual Care | Symptoms of Anxiety-Patients | 16.0 score on a scale | Standard Deviation 7 |
| Patients in Stepped Care Intervention | Symptoms of Anxiety-Patients | 13.9 score on a scale | Standard Deviation 6.6 |
Comparison: 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.p-value: 0.024395% CI: [0.19, 2.73]Mixed Models Analysis
Primary
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.
Time frame: 6-months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients in Enhanced Usual Care | Symptoms of Depression-Patients | 15.3 score on a scale | Standard Deviation 7 |
| Patients in Stepped Care Intervention | Symptoms of Depression-Patients | 13.2 score on a scale | Standard Deviation 5.7 |
Comparison: 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.p-value: 0.005795% CI: [0.52, 2.98]Mixed Models Analysis
Secondary
Caregiving Burden-Caregivers
Zarit Burden Interview (ZBI) (12 items). The range of scores is 0-48. Higher scores represent higher burden.
Time frame: 6-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients in Enhanced Usual Care | Caregiving Burden-Caregivers | 13 score on a scale | Standard Deviation 9 |
| Patients in Stepped Care Intervention | Caregiving Burden-Caregivers | 9 score on a scale | Standard Deviation 8 |
Comparison: 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.p-value: 0.004495% CI: [0.8, 4.32]Mixed Models Analysis
Secondary
Change in Coping-Caregivers
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.
Time frame: 6-months
Population: Intention to treat population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients in Enhanced Usual Care | Change in Coping-Caregivers | 192 score on a scale | Standard Deviation 52 |
| Patients in Stepped Care Intervention | Change in Coping-Caregivers | 211 score on a scale | Standard Deviation 50 |
Comparison: 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.p-value: 0.2195% CI: [-19.73, 4.27]Mixed Models Analysis
Secondary
Health-Related Quality of Life-Patients
FACT-G version 4 (27 items). The range is 0-108. Higher values indicate better QOL.
Time frame: 6-months
Population: Intention to treat population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients in Enhanced Usual Care | Health-Related Quality of Life-Patients | 73 score on a scale | Standard Deviation 19 |
| Patients in Stepped Care Intervention | Health-Related Quality of Life-Patients | 80 score on a scale | Standard Deviation 19 |
Comparison: 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.p-value: 0.013495% CI: [-7.45, -0.87]Mixed Models Analysis
Secondary
Perceived Stress-Caregivers
Perceived Stress Scale (PSS) (14 items). The range is from 0 to 40. Higher values indicate higher stress.
Time frame: 6-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients in Enhanced Usual Care | Perceived Stress-Caregivers | 15 score on a scale | Standard Deviation 7 |
| Patients in Stepped Care Intervention | Perceived Stress-Caregivers | 11 score on a scale | Standard Deviation 7 |
Comparison: 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.p-value: 0.026995% CI: [0.2, 3.34]Mixed Models Analysis
Secondary
Perceived Stress-Patients
Perceived Stress Scale (PSS) (14 items). The range of scores is 0-40. Higher values indicate higher stress.
Time frame: 6-months
Population: intention to treat population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients in Enhanced Usual Care | Perceived Stress-Patients | 14 score on a scale | Standard Deviation 7 |
| Patients in Stepped Care Intervention | Perceived Stress-Patients | 13 score on a scale | Standard Deviation 7 |
Comparison: 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.p-value: 0.4295% CI: [-0.9, 2.12]Mixed Models Analysis
Secondary
Symptoms of Anxiety-Caregivers
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.
Time frame: 6-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients in Enhanced Usual Care | Symptoms of Anxiety-Caregivers | 17 score on a scale | Standard Deviation 7 |
| Patients in Stepped Care Intervention | Symptoms of Anxiety-Caregivers | 14 score on a scale | Standard Deviation 7 |
Comparison: 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.p-value: 0.05295% CI: [-0.01, 3.05]Mixed Models Analysis
Secondary
Symptoms of Depression-Caregivers
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.
Time frame: 6-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients in Enhanced Usual Care | Symptoms of Depression-Caregivers | 15.0 score on a scale | Standard Deviation 6.9 |
| Patients in Stepped Care Intervention | Symptoms of Depression-Caregivers | 13.2 score on a scale | Standard Deviation 5.7 |
Comparison: 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.p-value: 0.21495% CI: [-0.52, 2.36]Mixed Models Analysis