CClinicalTrials.gg
RecruitingNCT04916990Updated Feb 5, 2026

Improving Care for Rural Patients With Solid Tumors

An interventional study of CARES Intervention in Lung Cancer, Head and Neck Cancer and Thyroid Cancer, sponsored by University of Colorado, Denver. Recruiting at 14 sites in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-02-05.

Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Started Sep 2022; still recruiting 4 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
320
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Lung Cancer
  • Head and Neck Cancer
  • Thyroid Cancer
  • Cervical Cancer
  • Breast Cancer
  • Bladder Cancer
  • Colon Cancer
  • Rectum Cancer
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 320 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.

Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria Assessed During Screening:

  1. Provision to sign and date the consent form.
  2. Stated willingness to comply with all study procedures and be available for the duration of the study.
  3. Male and female adults over 18 years old
  4. English or Spanish speaking
  5. 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.
  6. 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.
  7. 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
  8. 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)
  9. 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)
  10. 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
  11. Stage of diagnosis for HNC (Stages I, II, III, IV) according to the AJCC's TNM stages I-IV
  12. Diagnosed with malignant neoplasm of thyroid gland, ICD-10 code: C73, and other thyroid cancer variants
  13. 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.
  14. 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.
  15. 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.
  16. Diagnosed with BLC using malignant neoplasm of ICD-O codes: C67.9 and other bladder cancer varients.

    Inclusion Criteria Confirmed via Baseline Survey:

  17. 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
  18. Uninsured: No health insurance (public or private insurance) AND/OR
  19. 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

Exclusion Criteria Assessed During Screening:

  1. Children under 18 years old
  2. Individuals who do not speak English or Spanish
  3. 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.
  4. 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.
  5. 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,
  6. Has already initiated curative treatment for the current episode of cancer.

    Exclusion Criteria Assessed via Baseline Survey:

  7. Individuals from vulnerable populations (e.g., inmates or on probation, homeless*, and pregnant*)
  8. 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.
  9. Unable to hear (not including individuals who can hear with an auditory aid).*
  10. 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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
320 participants (estimated)

Study arms

  • Active comparator
    CARES 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.

    Behavioral: CARES Intervention

  • No intervention
    Usual Care

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

Interventions

  • BehavioralCARES Intervention

    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

06

What researchers measure

Primary outcomes

  1. Time to care

    Number of days from diagnosis to treatment initiation and number of days from treatment initiation to treatment completion

    Time frame: From study start to study end (6 months)

Secondary outcomes

  1. Quality of Care

    Use Quality of Care (QOC) questionnaire to determine if CARES intervention results in favorable QOC experience

    Time frame: From study start to study end (6 months)

  2. Patient Reported Outcomes

    Use Patient Reported Outcomes (PRO) questionnaire to determine if CARES intervention results in improvements in distress, adaptive coping, and tobacco use

    Time frame: From study start to study end (6 months)

07

Study locations

14 of 14 sites recruiting
  • University of Colorado Hospital
    Aurora, Colorado 80045, United States
    Recruiting
  • Memorial Hospital Central
    Colorado Springs, Colorado 80909, United States
    Recruiting
  • Memorial Hospital North
    Colorado Springs, Colorado 80920, United States
    Recruiting
  • Poudre Valley Hospital
    Fort Collins, Colorado 80524, United States
    Recruiting
  • SCL- St. Mary's Medical Center
    Grand Junction, Colorado 81501, United States
    Recruiting
  • VA Western Colorado Health Care System
    Grand Junction, Colorado 81501, United States
    Recruiting
  • Greeley Campus
    Greeley, Colorado 80634, United States
    Recruiting
  • Highlands Ranch Hospital
    Highlands Ranch, Colorado 80129, United States
    Recruiting
  • Medical Center of the Rockies
    Loveland, Colorado 80538, United States
    Recruiting
  • San Juan Cancer Center
    Montrose, Colorado 81401, United States
    Recruiting
  • Rocky Mountain Cancer Center
    Pueblo, Colorado 81003, United States
    Recruiting
  • UCHealth - Parkview medical Center
    Pueblo, Colorado 81003, United States
    Recruiting
  • Yampa Valley Medical Center
    Steamboat Springs, Colorado 80487, United States
    Recruiting
  • Huntsman Cancer Institute at the University of Utah
    Salt Lake City, Utah 84112, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04916990
Lead sponsor
University of Colorado, Denver
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jun 8, 2021
Start date
Sep 1, 2022
Primary completion
Jan 1, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Feb 5, 2026

Study contacts

Jennifer V Gonzalez, MS
Contact
jennifer.villalobosgonzalez@cuanschutz.edu
3037246278
Tatiana Gerena, MPH
Contact
tatiana.gerena@cuanschutz.edu
303-724-5439
Evelinn Borrayo, PhD
principal investigator · University of Colorado, Denver

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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