Improving Care for Rural Patients With Solid Tumors
Improving the Timeliness and Quality of Care for Rural Cancer Patients With Solid Tumors
3 other identifiers
interventional
320
1 country
14
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable lung-cancer
Started Sep 2022
Longer than P75 for not_applicable lung-cancer
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2021
CompletedFirst Posted
Study publicly available on registry
June 8, 2021
CompletedStudy Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
February 5, 2026
February 1, 2026
4.3 years
June 1, 2021
February 2, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Time to care
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 Outcomes (2)
Quality of Care
From study start to study end (6 months)
Patient Reported Outcomes
From study start to study end (6 months)
Study Arms (2)
CARES Intervention
ACTIVE COMPARATORAll 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 INTERVENTIONAll participants will complete surveys to assess Quality of Care and Patient Reported Outcomes. Patients will receive a standardized list of resources.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
- 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.
- +6 more criteria
You may not qualify if:
- 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.
- Has already initiated curative treatment for the current episode of cancer.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Colorado, Denverlead
- National Cancer Institute (NCI)collaborator
Study Sites (14)
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Memorial Hospital Central
Colorado Springs, Colorado, 80909, United States
Memorial Hospital North
Colorado Springs, Colorado, 80920, United States
Poudre Valley Hospital
Fort Collins, Colorado, 80524, United States
SCL- St. Mary's Medical Center
Grand Junction, Colorado, 81501, United States
VA Western Colorado Health Care System
Grand Junction, Colorado, 81501, United States
Greeley Campus
Greeley, Colorado, 80634, United States
Highlands Ranch Hospital
Highlands Ranch, Colorado, 80129, United States
Medical Center of the Rockies
Loveland, Colorado, 80538, United States
San Juan Cancer Center
Montrose, Colorado, 81401, United States
Rocky Mountain Cancer Center
Pueblo, Colorado, 81003, United States
UCHealth - Parkview medical Center
Pueblo, Colorado, 81003, United States
Yampa Valley Medical Center
Steamboat Springs, Colorado, 80487, United States
Huntsman Cancer Institute at the University of Utah
Salt Lake City, Utah, 84112, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Evelinn Borrayo, PhD
University of Colorado, Denver
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2021
First Posted
June 8, 2021
Study Start
September 1, 2022
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
February 5, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share