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CARES Intervention for Lung and Head & Neck Cancers
N/A
Recruiting
Led By Evelinn Borrayo, MD
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from study start to study end (6 months)
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I will receive specific treatments for lung cancer or head and neck cancer.
Select...
I have been diagnosed with lung or head and neck cancer.
Select...
I have been diagnosed with thyroid cancer.
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to care
Secondary outcome measures
Patient Reported Outcomes
Quality of Care
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.
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Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,734 Previous Clinical Trials
2,148,563 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,201 Total Patients Enrolled
Evelinn Borrayo, MDPrincipal InvestigatorUniversity of Colorado, Denver
1 Previous Clinical Trials
250 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am under 18 years old.I do not speak English or Spanish.I have started treatment aimed at curing my current cancer.I will receive specific treatments for lung cancer or head and neck cancer.I am an adult over 18 years old.I am unable to hear.I speak English or Spanish.My cancer's stage was determined using the TNM system.I have been diagnosed with lung or head and neck cancer.I have been diagnosed with thyroid cancer.My cancer type is not lung or head and neck, or it's a type not listed in the study criteria.I am able to make decisions and do not have severe mental health issues that would prevent me from participating.
Research Study Groups:
This trial has the following groups:- Group 1: Usual Care
- Group 2: CARES Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any new participants currently being enrolled in this research?
"The information on clinicaltrials.gov affirms that the trial is still accruing individuals, which it first started doing on June 29th 2022 and was most recently updated in August 1st 2022."
Answered by AI
How many patients will be receiving treatments through this trial?
"Affirmative. The information available on clinicaltrials.gov confirms that enrollment for this study is open, with a start date of June 29th 2022 and the latest update occurring August 1st 2022. A total of 320 patients will be needed from two sites to complete the trial."
Answered by AI
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