A Stepped Care Intervention to Reduce Disparities in Ment... | NCT03016403

NCT03016403

ID	Type	Description	Link
AD-1511-33395	Other Grant/Funding Number	PCORI

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stepped-Care Intervention	Experimental	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
Enhanced Usual Care	Active Comparator	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Stepped-Care Intervention	Behavioral	The intervention delivered evidence-based CBT and stress management across eight counseling sessions.	Stepped-Care Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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.	6-months
Symptoms of Anxiety-Caregivers

Eligibility Module

Eligibility Criteria

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.
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.

Contacts/Locations Module

Name	Affiliation	Role
Evelinn A Borrayo, PhD	University of Colorado, Denver	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Denver Health Medical Center		Denver	Colorado	80204	United States
University of Colorado Denver

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37772984	Derived	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.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Patients in Enhanced Usual Care	Patients who were randomized to Enhanced Usual Care
FG001	Patients in Stepped Care Intervention	Patients who were randomized to the Stepped Care Intervention

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Nov 30, 2018

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Patients in Enhanced Usual Care	Patients who were randomized to Enhanced Usual Care
BG001	Patients in Stepped Care Intervention	Patients who were randomized to the Stepped Care Intervention
BG002	Caregivers in Enhanced Usual Care	Caregivers who were randomized to Enhanced Usual Care
BG003	Caregivers in Stepped Care Intervention	Caregivers who were randomized to the Stepped Care Intervention
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG000139 BG001147 BG002118 BG003131 BG004535

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000139 ParticipantsBG001147 ParticipantsBG002118 ParticipantsBG003

Sex: Female, Male

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000139 ParticipantsBG001147 ParticipantsBG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000139 ParticipantsBG001147 ParticipantsBG002

Race (NIH/OMB)

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000139 ParticipantsBG001147 ParticipantsBG002

Region of Enrollment

Number

participants

Title	Denominators	Categories
United States	ParticipantsBG000139 ParticipantsBG001147 ParticipantsBG002

Language Preference

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000139 ParticipantsBG001147 ParticipantsBG002

Diagnosis

Diagnosis data were not collected from caregivers.

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000139 ParticipantsBG001147 ParticipantsBG002

Cancer Stage

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.

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000139 ParticipantsBG001147 ParticipantsBG002

Step at Baseline

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

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000139 ParticipantsBG001147 ParticipantsBG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

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.

Posted

Mean

Standard Deviation

score on a scale

6-months

ID	Title	Description
OG000	Patients in Enhanced Usual Care	Patients who were randomized to Enhanced Usual Care
OG001	Patients in Stepped Care Intervention	Patients who were randomized to the Stepped Care Intervention

Units	Counts
Participants	OG000139 OG001147

Title

Denominators

Categories

Title	Measurements
	OG00015.3± 7.0 OG00113.2± 5.7

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	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.	Mixed Models Analysis	The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).	0.0057	Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).	Mean Difference (Final Values)	1.75			2-Sided	95	0.52	2.98

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.

Intention to treat population.

Posted

Mean

Standard Deviation

score on a scale

6-months

ID	Title	Description
OG000	Enhanced Usual Care	Enhanced Usual Care: Consists of a list of standard mental health resources offered at the participating hospital, local community, or national non-profit organizations.
OG001	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. Stepped-Care Intervention: The intervention delivered evidence-based CBT and stress management across eight counseling sessions.

Primary

Change in Coping-Patients

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

Intention to treat population.

Posted

Mean

Standard Deviation

score on a scale

6-months

ID	Title	Description
OG000	Enhanced Usual Care	Enhanced Usual Care: Consists of a list of standard mental health resources offered at the participating hospital, local community, or national non-profit organizations.
OG001	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. Stepped-Care Intervention: The intervention delivered evidence-based CBT and stress management across eight counseling sessions.

Units	Counts
Participants

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.

Intention to treat population.

Posted

Mean

Standard Deviation

score on a scale

6-months

ID	Title	Description
OG000	Enhanced Usual Care	Enhanced Usual Care: Consists of a list of standard mental health resources offered at the participating hospital, local community, or national non-profit organizations.
OG001	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. Stepped-Care Intervention: The intervention delivered evidence-based CBT and stress management across eight counseling sessions.

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.

Posted

Mean

Standard Deviation

score on a scale

6-months

ID	Title	Description
OG000	Caregivers in Enhanced Usual Care	Caregivers who were randomized to Enhanced Usual Care
OG001	Caregivers in Stepped Care Intervention	Caregivers who were randomized to the Stepped Care Intervention

Units	Counts
Participants	OG000

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.

Posted

Mean

Standard Deviation

score on a scale

6-months

ID	Title	Description
OG000	Caregivers in Enhanced Usual Care	Caregivers who were randomized to Enhanced Usual Care
OG001	Caregivers in Stepped Care Intervention	Caregivers who were randomized to the Stepped Care Intervention

Units	Counts
Participants	OG000

Secondary

Health-Related Quality of Life-Patients

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

Intention to treat population.

Posted

Mean

Standard Deviation

score on a scale

6-months

ID	Title	Description
OG000	Patients in Enhanced Usual Care	Patients who were randomized to Enhanced Usual Care
OG001	Patients in Stepped Care Intervention	Patients who were randomized to the Stepped Care Intervention

Units	Counts
Participants	OG000

Secondary

Perceived Stress-Patients

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

intention to treat population

Posted

Mean

Standard Deviation

score on a scale

6-months

ID	Title	Description
OG000	Patients in Enhanced Usual Care	Patients who were randomized to Enhanced Usual Care
OG001	Patients in Stepped Care Intervention	Patients who were randomized to the Stepped Care Intervention

Units	Counts
Participants	OG000

Secondary

Perceived Stress-Caregivers

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

Posted

Mean

Standard Deviation

score on a scale

6-months

ID	Title	Description
OG000	Caregivers in Enhanced Usual Care	Caregivers who were randomized to Enhanced Usual Care
OG001	Caregivers in Stepped Care Intervention	Caregivers who were randomized to the Stepped Care Intervention

Units	Counts
Participants	OG000

Secondary

Caregiving Burden-Caregivers

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

Posted

Mean

Standard Deviation

score on a scale

6-months

ID	Title	Description
OG000	Caregivers in Enhanced Usual Care	Caregivers who were randomized to Enhanced Usual Care
OG001	Caregivers in Stepped Care Intervention	Caregivers who were randomized to the Stepped Care Intervention

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (At Risk)
EG000	Patients in Enhanced Usual Care	Patients who were randomized to Enhanced Usual Care	13	139	13	139	139
EG001	Patients in Stepped Care Intervention	Patients who were randomized to the Stepped Care Intervention	18	147	19	147	147
EG002	Caregivers in Enhanced Usual Care	Caregivers who were randomized to Enhanced Usual Care	1	118	1	118	118
EG003	Caregivers in Stepped Care Intervention	Caregivers who were randomized to the Stepped Care Intervention	0	131	0	131	131

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Death	General disorders		Systematic Assessment	Head-and-neck/lung cancer or complications related to the diagnoses	EG00013 events13 affected139 at risk EG00118 events18 affected147 at risk EG0021 events1 affected118 at risk EG0030 events0 affected131 at risk
Respiratory failure with hypoxia	Respiratory, thoracic and mediastinal disorders		Systematic Assessment		EG0000 events0 affected139 at risk EG0011 events1 affected147 at risk EG0020 events0 affected118 at risk EG003

ID	Term
D008175	Lung Neoplasms
D006258	Head and Neck Neoplasms

ID	Term
D059039	Standard of Care

ParticipantsBG004535

ParticipantsBG003131

ParticipantsBG004535

ParticipantsBG003131

ParticipantsBG004535

ParticipantsBG003131

ParticipantsBG004535

ParticipantsBG003131

ParticipantsBG004535

ParticipantsBG003131

ParticipantsBG004535

ParticipantsBG004286

ParticipantsBG003131

ParticipantsBG004535

The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation