Improving Care for Rural Patients With Solid Tumors

February 2, 2026 updated by: University of Colorado, Denver

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

320

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
      • Colorado Springs, Colorado, United States, 80920
      • Colorado Springs, Colorado, United States, 80909
      • Fort Collins, Colorado, United States, 80524
      • Grand Junction, Colorado, United States, 81501
        • Recruiting
        • SCL- St. Mary's Medical Center
        • Contact:
      • Grand Junction, Colorado, United States, 81501
      • Greeley, Colorado, United States, 80634
      • Highlands Ranch, Colorado, United States, 80129
        • Recruiting
        • Highlands Ranch Hospital
        • Principal Investigator:
          • Ryan Lanning, MD
        • Principal Investigator:
          • Poojitha Valasareddy, MD
        • Contact:
      • Loveland, Colorado, United States, 80538
      • Montrose, Colorado, United States, 81401
      • Pueblo, Colorado, United States, 81003
      • Pueblo, Colorado, United States, 81003
        • Recruiting
        • UCHealth - Parkview medical Center
        • Contact:
        • Principal Investigator:
          • Evelinn Borrayo, MD
      • Steamboat Springs, Colorado, United States, 80487
    • Utah
      • Salt Lake City, Utah, United States, 84112

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From study start to study end (6 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Care
Time Frame: From study start to study end (6 months)
Use Quality of Care (QOC) questionnaire to determine if CARES intervention results in favorable QOC experience
From study start to study end (6 months)
Patient Reported Outcomes
Time Frame: From study start to study end (6 months)
Use Patient Reported Outcomes (PRO) questionnaire to determine if CARES intervention results in improvements in distress, adaptive coping, and tobacco use
From study start to study end (6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Evelinn Borrayo, PhD, University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

June 1, 2021

First Submitted That Met QC Criteria

June 1, 2021

First Posted (Actual)

June 8, 2021

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-2666.cc
  • P30CA046934 (U.S. NIH Grant/Contract)
  • R01CA254730-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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