Lung CancerNCT04916990
Improving Care for Rural Patients With Solid Tumors
A study testing CARES Intervention in people with Lung Cancer and Head and Neck Cancer, run by University of Colorado, Denver at 14 sites in United States.
Trial summary
This study will assess if the CARES (Cancer Advocacy, Resources, Education and Support) intervention improves time to start of treatment after diagnosis and time to treatment completion for solid tumors (ex: lung, head, neck, thyroid, cervical, breast, bladder, colon, and rectal cancers) in rural patients. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Lung Cancer, Head and Neck Cancer, Thyroid Cancer
- What is being tested?
- CARES Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 14 sitesUnited States
- Study dates
- 1 Sep 2022to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision to sign and date the consent form.
- Stated willingness to comply with all study procedures and be available for the duration of the study.
- Male and female adults over 18 years old
- English or Spanish speaking
- Receives cancer treatment at UCH- Aurora, UCH-Highlands Ranch, UCHealth North, UCHealth South- UCHealth Memorial Hospital, UCHealth Parkview Hospital, San Juan Cancer Center, RMCC-Pueblo, SCL-St. Mary's, or Parkview Medical Center.
- Resides in any of the rural counties served by the UCH-Aurora, UCH-Highlands Ranch, UCHealth North, UCHealth South- UCHealth Memorial Hospital, UCHealth Parkview Hospital, San Juan Cancer Center, RMCC-Pueblo, SCL-St. Mary's, VA, Huntsman Cancer Institute, or Parkview Medical Center with Rural-Urban Continuum Codes (RUCC) codes 4-9.
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- Diagnosed with lung cancer (LC): small cell lung cancer (SCLC), non-small cell lung cancer (NSCLC), using incident LC diagnosis according to the International Classification of Diseases for Oncology [ICD-O] codes: C34.0, C34.1, C34.2, C34.3, C34.8, C34.9, and C33.9, and other lung cancer variants
- Stage of diagnosis for SCLC (limited vs. extensive), NSCLC (Stages 0, I, II, IIA, IIIB, IV), according to the American Joint Committee on Cancer Staging [AJCC] Tumor Node Metastasis [TNM] stages: I-IV)
- Will receive the following types of breast, bladder, cervix, colon, rectum, lung, head-and-neck cancer treatments (surgery, radiation therapy, chemotherapy, or a combination of those modalities, including neoadjuvant and adjuvant therapy)
- Diagnosed with head and neck cancer (HNC) using head and neck squamous cell carcinoma (HNSCC) ICD-O codes for the oral cavity (including lip; codes C00.0-C00.6, C00.8, C00.9, C02.0-C02.3, C02.8, C0.2.9, C03.0, C03.1, C03.9-C04.1, C04.8-C05.0, C06.0-C06.2, C06.8, and C06.9), the oropharynx (codes C01.9, C02.4, C05.1, C05.2, C5.8, C5.9, C09.0, C09.1, C09.8-C10.4, C10.8, C10.9, C14.0, C14.2, and C14.8), the hypopharynx (codes C12.9-C13.2, C13.8, and C13.9), and the larynx (codes C32.0- C32.3 and C32.8-C32.9) and histology codes for squamous cell carcinoma (SCC) or its variants (codes 8032, 8050, 8052, 8070-8075, and 8083-8084), and salivary gland cancer (code C07 and variants), and other head and neck cancer variants
- Stage of diagnosis for HNC (Stages I, II, III, IV) according to the AJCC's TNM stages I-IV
- Diagnosed with malignant neoplasm of thyroid gland, ICD-10 code: C73, and other thyroid cancer variants
- Diagnosed with BC using malignant neoplasm of breast ICD-O codes for connective tissue of the breast, codes: C50.0, C50.1, C50.2, C50.3, C50.4, C50.5, C50.6, C50.8, C50.9, and other breast cancer variants.
- Diagnosed with CC using malignant neoplasm of cervix uteri ICD-O codes: C53.0, C53.1, C53.8, C53.9 and other cervical cancer variants.
- Diagnosed with CRC using colon and rectum malignant neoplasm ICD-O codes for colon (codes: C18, C18.1, C18.2, C18.3, C18.4, C18.5, C18.6, C18.7, C18.8, C18.9) and rectum (code C20), and other colon and rectum cancer variants.
- Diagnosed with BLC using malignant neoplasm of ICD-O codes: C67.9 and other bladder cancer varients.
- Rural and medically underserved, defined as meeting the following criteria:
- Rural: Resides in a rural county with a RUCC code 4-9 AND,
- Underserved population who come from counties meeting any of the "health professional shortage areas" OR "Medically Underserved Areas/Populations" AND/OR
- Uninsured: No health insurance (public or private insurance) AND/OR
- Underinsured: (c.1) Public insurance (e.g., Medicaid, Medicare Part B exclusive, VA) (c.2) 10% or more of annual income is spent on out-of-pocket medical expenses
Who cannot join
- Children under 18 years old
- Individuals who do not speak English or Spanish
- Individuals not receiving cancer treatment at UCH (Aurora, Highlands Ranch, UCHealth North, UCHealth Memorial Hospital), San Juan Cancer Center, RMCC-Pueblo, St. Mary's or Parkview Medical Center.
- Diagnosed with primary cancer other than breast, bladder, cervix, colon, rectum, lung, and/or head-and-neck cancer or other type of cancer not listed in the inclusion criteria.
- Diagnosed with a type of breast, bladder, cervix, colon, rectum, lung, and/or head-and-neck cancer listed under inclusion criteria but will not be treated at one of the collaborating hospital sites,
- Has already initiated curative treatment for the current episode of cancer.
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- Individuals from vulnerable populations (e.g., inmates or on probation, homeless*, and pregnant*)
- Decisionally-challenged with cognitive or personality impairment, suicidal ideation or intoxication (alcohol or drugs) at the time of consent or endorsed in baseline survey that interfere with ability to participate in the study.
- Unable to hear (not including individuals who can hear with an auditory aid).*
- Likely inability to track the individual over time (e.g. no permanent address at the time of consent) *Individuals who become homeless, pregnant, or lose their hearing or permanent address after they have consented and/or assigned to study condition may remain in the study until completion
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
United States14 sites, 14 recruiting
- Recruiting
University of Colorado Hospital
Aurora, Colorado, 80045
Jennifer V Gonzalez, cc_timelinessstudy@cuanschutz.edu
- Recruiting
Memorial Hospital Central
Colorado Springs, Colorado, 80909
Jennifer V Gonzalez, cc_timelinessstudy@cuanschutz.edu
- Recruiting
Memorial Hospital North
Colorado Springs, Colorado, 80920
Jennifer V Gonzalez, cc_timelinessstudy@cuanschutz.edu
- Recruiting
Poudre Valley Hospital
Fort Collins, Colorado, 80524
Jennifer V Gonzalez, cc_timelinessstudy@cuanschutz.edu
Steven Schuster, MD
- Recruiting
SCL- St. Mary's Medical Center
Grand Junction, Colorado, 81501
Marty Jacobsen, 970-298-1822, Marty.Jacobson@sclhs.net
- Recruiting
VA Western Colorado Health Care System
Grand Junction, Colorado, 81501
Jennifer Gonzalez, MS, 303-724-6278, jennifer.villalobosgonzalez@cuanschutz.edu
- Recruiting
Greeley Campus
Greeley, Colorado, 80634
Jennifer V Gonzalez, cc_timelinessstudy@cuanschutz.edu
Steven Schuster, MD
- Recruiting
Highlands Ranch Hospital
Highlands Ranch, Colorado, 80129
Jennifer V Gonzalez, cc_timelinessstudy@cuanschutz.edu
Ryan Lanning, MD
- Recruiting
Medical Center of the Rockies
Loveland, Colorado, 80538
Jennifer V Gonzalez, cc_timelinessstudy@cuanschutz.edu
Steven Schuster, MD
- Recruiting
San Juan Cancer Center
Montrose, Colorado, 81401
Jennifer P Gonzalez, cc_timelinessstudy@cuanschutz.edu
- Recruiting
Rocky Mountain Cancer Center
Pueblo, Colorado, 81003
Jennifer V Gonzalez, cc_timelinessstudy@cuanschutz.edu
- Recruiting
UCHealth - Parkview medical Center
Pueblo, Colorado, 81003
Sindy Gonzalez, 303-724-5445, sindy.gonzalez@cuanschutz.edu
Evelinn Borrayo, MD
- Recruiting
Huntsman Cancer Institute at the University of Utah
Salt Lake City, Utah, 84112
Jennifer Gonzalez, MS, 303-724-6278, jennifer.villalobosgonzalez@cuanschutz.edu
- Recruiting
Yampa Valley Medical Center
Steamboat Springs, Colorado, 80487
Jennifer V Gonzalez, cc_timelinessstudy@cuanschutz.edu
Steven Schuster, MD
About this study
Official title: Improving the Timeliness and Quality of Care for Rural Cancer Patients With Solid Tumors
This study will assess if the CARES (Cancer Advocacy, Resources, Education and Support) intervention improves time to start of treatment after diagnosis and time to treatment completion for solid tumors (ex: lung, head, neck, thyroid, cervical, breast, bladder, colon, and rectal cancers) in rural patients.
Read the detailed description
This is a randomized study. 320 participants will be enrolled to the CARES intervention or usual care arms. 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. Patients enrolled to the usual care arm will receive a standardized list of resources. Participation will last 6 months.
- Conditions
- Lung Cancer, Head and Neck Cancer, Thyroid Cancer, Cervical Cancer, Breast Cancer, Bladder Cancer
- Being tested
- CARES Intervention
- Medical subject headings
- Lung Neoplasms, Head and Neck Neoplasms, Thyroid Neoplasms, Uterine Cervical Neoplasms, Breast Neoplasms, Urinary Bladder Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CARES InterventionBehavioural
Nurse navigators and masters levels counselors will meet with participants up to 10 times each (10 navigation and 10 counseling) over a 6 month period. The number of sessions will be determined by the length of the patient's treatment. The timing of each session will be guided by a regular assessment to reduce the time from diagnosis to initiation of treatment and the time between subsequent treatments. Sessions will occur at key transition points during treatment to target the factors associated with treatment delays, reduced Quality of Care and poor Patient Reported Outcomes
| Study group | Role | What they receive |
|---|---|---|
| CARES Intervention | Active comparator | 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. Receives: Behavioral: CARES Intervention |
| Usual Care | No intervention | All participants will complete surveys to assess Quality of Care and Patient Reported Outcomes. Patients will receive a standardized list of resources. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to care
Number of days from diagnosis to treatment initiation and number of days from treatment initiation to treatment completion
Measured: From study start to study end (6 months)
Secondary outcomes (2)
Quality of Care
Use Quality of Care (QOC) questionnaire to determine if CARES intervention results in favorable QOC experience
Measured: From study start to study end (6 months)
Patient Reported Outcomes
Use Patient Reported Outcomes (PRO) questionnaire to determine if CARES intervention results in improvements in distress, adaptive coping, and tobacco use
Measured: From study start to study end (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start1 Sep 2022
- Primary completion1 Jan 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Evelinn Borrayo, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04916990
- Sponsor's protocol ID
- 21-2666.cc
- Other IDs
- P30CA046934, R01CA254730-01
- Status last verified
- Feb 2026
- First submitted
- 1 Jun 2021
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Timeliness and Quality of Care for Rural Cancer Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT04916990
- Acronym / sponsor ID
- 21-2666.cc
- Conditions
- Lung Cancer, Head and Neck Cancer, Thyroid Cancer, Cervical Cancer, Breast Cancer, Bladder Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 8 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess if the CARES (Cancer Advocacy, Resources, Education and Support) intervention improves time to start of treatment after diagnosis and time to treatment completion for solid tumors (ex: lung, head, neck, thyroid, cervical, breast, bladder, colon, and rectal cancers) in rural patients.
Detailed description
This is a randomized study. 320 participants will be enrolled to the CARES intervention or usual care arms. 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. Patients enrolled to the usual care arm will receive a standardized list of resources. Participation will last 6 months.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CARES Intervention | Active comparator | Behavioral: CARES InterventionAll 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. |
| Usual Care | No intervention | –All participants will complete surveys to assess Quality of Care and Patient Reported Outcomes. Patients will receive a standardized list of resources. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Provision to sign and date the consent form.
- Stated willingness to comply with all study procedures and be available for the duration of the study.
- Male and female adults over 18 years old
- English or Spanish speaking
- Receives cancer treatment at UCH- Aurora, UCH-Highlands Ranch, UCHealth North, UCHealth South- UCHealth Memorial Hospital, UCHealth Parkview Hospital, San Juan Cancer Center, RMCC-Pueblo, SCL-St. Mary's, or Parkview Medical Center.
Key exclusion criteria (10 listed)
- Children under 18 years old
- Individuals who do not speak English or Spanish
- Individuals not receiving cancer treatment at UCH (Aurora, Highlands Ranch, UCHealth North, UCHealth Memorial Hospital), San Juan Cancer Center, RMCC-Pueblo, St. Mary's or Parkview Medical Center.
- Diagnosed with primary cancer other than breast, bladder, cervix, colon, rectum, lung, and/or head-and-neck cancer or other type of cancer not listed in the inclusion criteria.
- Diagnosed with a type of breast, bladder, cervix, colon, rectum, lung, and/or head-and-neck cancer listed under inclusion criteria but will not be treated at one of the collaborating hospital sites,
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 |
|---|---|---|
| CARES InterventionNurse navigators and masters levels counselors will meet with participants up to 10 times each (10 navigation and 10 counseling) over a 6 month period. The number of sessions will be determined by the length of the patient's treatment. The timing of each session will be guided by a regular assessment to reduce the time from diagnosis to initiation of treatment and the time between subsequent treatments. Sessions will occur at key transition points during treatment to target the factors associated with treatment delays, reduced Quality of Care and poor Patient Reported Outcomes | Behavioural | CARES Intervention |
Primary outcome
Time to care
Time frame: From study start to study end (6 months)
Number of days from diagnosis to treatment initiation and number of days from treatment initiation to treatment completion
2 secondary outcomes
Quality of Care
Time frame: From study start to study end (6 months)
Patient Reported Outcomes
Time frame: From study start to study end (6 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- 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.
Evelinn Borrayo, PhD principal investigator
University of Colorado, Denver
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CARES Intervention in people with Lung Cancer and Head and Neck Cancer, run by University of Colorado, Denver at 14 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 21 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer V Gonzalez, MS (3037246278, jennifer.villalobosgonzalez@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to care (time frame: From study start to study end (6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2026.