Improving the Timeliness and Quality of Care for Rural Cancer Patients With Solid Tumors

Status: Recruiting
Location: See all (14) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• 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.

⁃ 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

Locations
United States
Colorado
University of Colorado Hospital
RECRUITING
Aurora
Memorial Hospital Central
RECRUITING
Colorado Springs
Memorial Hospital North
RECRUITING
Colorado Springs
Poudre Valley Hospital
RECRUITING
Fort Collins
SCL- St. Mary's Medical Center
RECRUITING
Grand Junction
VA Western Colorado Health Care System
RECRUITING
Grand Junction
Greeley Campus
RECRUITING
Greeley
Highlands Ranch Hospital
RECRUITING
Highlands Ranch
Medical Center of the Rockies
RECRUITING
Loveland
San Juan Cancer Center
RECRUITING
Montrose
Rocky Mountain Cancer Center
RECRUITING
Pueblo
UCHealth - Parkview medical Center
RECRUITING
Pueblo
Yampa Valley Medical Center
RECRUITING
Steamboat Springs
Utah
Huntsman Cancer Institute at the University of Utah
RECRUITING
Salt Lake City
Contact Information
Primary
Jennifer V Gonzalez, MS
jennifer.villalobosgonzalez@cuanschutz.edu
3037246278
Backup
Tatiana Gerena, MPH
tatiana.gerena@cuanschutz.edu
303-724-5439
Time Frame
Start Date: 2022-09-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 320
Treatments
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.
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.
Sponsors
Collaborators: National Cancer Institute (NCI)
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov