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CARES Intervention for Lung and Head & Neck Cancers

N/A

Recruiting

Led By Evelinn Borrayo, PhD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Will receive specified types of LC and/or HNC treatments

Diagnosed with lung cancer (LC) or head and neck cancer (HNC) using specified ICD-O codes

Must not have

Children under 18 years old

Individuals who do not speak English or Spanish

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from study start to study end (6 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial will see if the CARES intervention (Cancer Advocacy, Resources, Education and Support) can help improve treatment times for lung and head & neck cancer patients.

Who is the study for?

Adults over 18 with lung or head and neck cancer, who speak English or Spanish, live in rural areas with limited healthcare access, and will receive standard treatments. They must be diagnosed at specific stages and treated at certain Colorado centers. Excluded are those with other primary cancers, hearing loss without aids, already started treatment, decisionally-challenged individuals or those not treated at the specified sites.

What is being tested?

The CARES intervention is being tested to see if it can shorten the time between diagnosis and start of treatment as well as the time to complete treatment for patients with Lung Cancer and Head and Neck Cancer in rural settings.

What are the potential side effects?

Since this trial tests a support intervention rather than a drug, there may not be direct side effects like those seen with medication. However, participants might experience stress or discomfort related to participation in educational sessions or assessments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I will receive specific treatments for lung cancer or head and neck cancer.

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I have been diagnosed with lung or head and neck cancer.

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I have been diagnosed with thyroid cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

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I do not speak English or Spanish.

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I have started treatment aimed at curing my current cancer.

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My cancer type is not lung or head and neck, or it's a type not listed in the study criteria.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from study start to study end (6 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from study start to study end (6 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from study start to study end (6 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to care

Secondary study objectives

Patient Reported Outcomes

Quality of Care

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Usual CareActive Control1 Intervention

All participants will complete surveys to assess Quality of Care and Patient Reported Outcomes. Patients will receive a standardized list of resources.

Group II: CARES InterventionActive Control1 Intervention

All participants will complete surveys to assess Quality of Care and Patient Reported outcomes at baseline, 3 months and 6 months. The CARES intervention will include a maximum of 10 navigation and 10 counseling sessions delivered over approximately a 6- month period delivered by oncology nurse navigators and master's level counselors. Sessions will be scheduled to correspond with key transition points during treatment and may be held in person, virtually, or by phone.

0 / 7Eligibility criteria met