Cancer, LungNCT03016403

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

A study testing Stepped-Care Intervention in people with Cancer, Lung and Cancer, Head and Neck, run by University of Colorado, Denver at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Cancer, Lung, Cancer, Head and Neck
What is being tested?: Stepped-Care Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 535 participants
Where: 5 sitesUnited States
Study dates: 3 Apr 2017to 17 Jul 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

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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.
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:
Low-income: Below 400% of the 2016 Federal poverty levels;
Uninsured: No health insurance (public or private insurance);
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.

Who cannot join

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,

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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
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:
cognitive or personality impairment,
suicidal ideation, or
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:
vulnerable populations (e.g., inmates or individuals on probation, homeless,
pregnant women, and
those with auditory impairment [at the discretion of the Site Coordinators upon recruitment]).
Individuals who become pregnant or develop auditory impairments after they have been randomized to study condition may remain in the study until completion.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Denver Health Medical Center
Denver, Colorado, 80204
University of Colorado Denver
Denver, Colorado, 80204
National Jewish Health
Denver, Colorado, 80206
Saint Joseph Hospital
Denver, Colorado, 80218
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, 81502

Other trials in United States

About this study

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

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).

Conditions: Cancer, Lung, Cancer, Head and Neck
Being tested: Stepped-Care Intervention, Enhanced Usual Care
Medical subject headings: Lung Neoplasms, Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Stepped-Care InterventionBehavioural
The intervention delivered evidence-based CBT and stress management across eight counseling sessions.
Enhanced Usual CareBehavioural
Also called Standard of Care
Consists of a list of standard mental health resources offered at the participating hospital, local community, or national non-profit organizations.

Study groups in NCT03016403
Study group	Role	What they receive
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. Receives: 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. Receives: Behavioral: Enhanced Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 6-months
Change in Coping-Patients
Coping Self-Efficacy (26 items). Scores can rage from 0 to 260. Higher score corresponds to better outcome.
Measured: 6-months

Secondary outcomes (7)

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.
Measured: 6-months
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.
Measured: 6-months
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.
Measured: 6-months
Health-Related Quality of Life-Patients
FACT-G version 4 (27 items). The range is 0-108. Higher values indicate better QOL.
Measured: 6-months
Perceived Stress-Patients
Perceived Stress Scale (PSS) (14 items). The range of scores is 0-40. Higher values indicate higher stress.
Measured: 6-months
Perceived Stress-Caregivers
Perceived Stress Scale (PSS) (14 items). The range is from 0 to 40. Higher values indicate higher stress.
Measured: 6-months
Caregiving Burden-Caregivers
Zarit Burden Interview (ZBI) (12 items). The range of scores is 0-48. Higher scores represent higher burden.
Measured: 6-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Apr 201717 Jul 2020

First posted10 Jan 2017 (estimated)
Study start3 Apr 2017
Primary completion17 Jul 2020
Study completion17 Jul 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Cancer, LungStudies of the same condition, open and under way.
More trials run by University of Colorado, DenverThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 535 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03016403
Sponsor's protocol ID: 16-2621.cc
Other IDs: AD-1511-33395
Status last verified: Feb 2021
First submitted: 27 Dec 2016
Last updated: 19 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 37772984

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03016403
Acronym / sponsor ID: 16-2621.cc
Conditions: Cancer, Lung, Cancer, Head and Neck
Study type: Interventional
Recruitment status: Completed
Enrolment: 535 participants (actual)
Lead sponsor: University of Colorado, DenverUniversity, hospital or other
Study start: 3 Apr 2017 (actual)
Primary completion: 17 Jul 2020 (actual)
Study completion: 17 Jul 2020 (actual)
First posted: 10 Jan 2017 (estimated)
Results: Posted 19 Mar 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Stepped-Care Intervention	Experimental	Behavioral: Stepped-Care InterventionIntervention 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 comparator	Behavioral: Enhanced Usual CareDenver 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

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:
(c.1) Public insurance (i.e., Medicaid, Medicare exclusive, VA);

Key exclusion criteria (22 listed)

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
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:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Stepped-Care InterventionThe intervention delivered evidence-based CBT and stress management across eight counseling sessions.	Behavioural	Stepped-Care Intervention
Enhanced Usual CareAlso: Standard of CareConsists of a list of standard mental health resources offered at the participating hospital, local community, or national non-profit organizations.	Behavioural	Enhanced Usual Care

Primary outcome

Symptoms of Depression-Patients
Time frame: 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
Time frame: 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
Time frame: 6-months
Coping Self-Efficacy (26 items). Scores can rage from 0 to 260. Higher score corresponds to better outcome.

7 secondary outcomes

Change in Coping-Caregivers
Time frame: 6-months
Symptoms of Anxiety-Caregivers
Time frame: 6-months
Symptoms of Depression-Caregivers
Time frame: 6-months
Health-Related Quality of Life-Patients
Time frame: 6-months
Perceived Stress-Patients
Time frame: 6-months
Perceived Stress-Caregivers
Time frame: 6-months
Caregiving Burden-Caregivers
Time frame: 6-months

Results and safety

Results posted to the registry on 19 Mar 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients in Enhanced Usual Care	139	123
Patients in Stepped Care Intervention	147	120
Caregivers in Enhanced Usual Care	118	107
Caregivers in Stepped Care Intervention	131	97

Primary outcome: Symptoms of Depression-Patients

Time frame: 6-months. Mean (Standard Deviation). Unit: score on a scale

Measure	Patients in Enhanced Usual Care n = 139	Patients in Stepped Care Intervention n = 147
Value	15.3 (7.0)	13.2 (5.7)

Patients in Enhanced Usual Care vs Patients in Stepped Care Intervention: Mean Difference (Final Values): 1.75 (95% CI 0.52 to 2.98), p = 0.0057, Mixed Models Analysis

Population analysed: 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.

Primary outcome: Symptoms of Anxiety-Patients

Time frame: 6-months. Mean (Standard Deviation). Unit: score on a scale

Measure	Enhanced Usual Care n = 139	Stepped-Care Intervention n = 147
Value	16.0 (7.0)	13.9 (6.6)

Enhanced Usual Care vs Stepped-Care Intervention: Mean Difference (Final Values): 1.46 (95% CI 0.19 to 2.73), p = 0.0243, Mixed Models Analysis

Population analysed: Intention to treat population.

Primary outcome: Change in Coping-Patients

Time frame: 6-months. Mean (Standard Deviation). Unit: score on a scale

Measure	Enhanced Usual Care n = 139	Stepped-Care Intervention n = 147
Value	190 (55)	207 (54)

Enhanced Usual Care vs Stepped-Care Intervention: Mean Difference (Final Values): -15.31 (95% CI -26.23 to -4.39), p = 0.0061, Mixed Models Analysis

Population analysed: Intention to treat population.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Between baseline through the six month follow-up. Adverse events can be reported by the study coordinators at anytime from baseline through completion of the 6 month follow-up.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients in Enhanced Usual Care	13 of 139 (9.4%)	0 of 139 (0%)	13 of 139
Patients in Stepped Care Intervention	19 of 147 (12.9%)	0 of 147 (0%)	18 of 147
Caregivers in Enhanced Usual Care	1 of 118 (0.8%)	0 of 118 (0%)	1 of 118
Caregivers in Stepped Care Intervention	0 of 131 (0%)	0 of 131 (0%)	0 of 131

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37772984Borrayo 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Evelinn A Borrayo, PhD principal investigator

University of Colorado, Denver

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Stepped-Care Intervention in people with Cancer, Lung and Cancer, Head and Neck, run by University of Colorado, Denver at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Symptoms of Depression-Patients (time frame: 6-months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03016403, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2021.