Improving Care for Rural Patients With Solid Tumors

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04916990
• Other study ID #: 21-2666.cc
• Secondary ID: P30CA046934R01CA
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: June 30, 2026

Study information

• Verified date: May 2024
• Source: University of Colorado, Denver
• Contact: Jennifer V Gonzalez, MS
• Phone: 3037240886
• Email: jennifer.villalobosgonzalez[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: June 30, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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, or SCL-St. Mary's.

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 or SCL-St. Mary's 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

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, or St. Mary's.

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado
United States	Memorial Hospital Central	Colorado Springs	Colorado
United States	Memorial Hospital North	Colorado Springs	Colorado
United States	Poudre Valley Hospital	Fort Collins	Colorado
United States	SCL- St. Mary's Medical Center	Grand Junction	Colorado
United States	Greeley Campus	Greeley	Colorado
United States	Highlands Ranch Hospital	Highlands Ranch	Colorado
United States	Medical Center of the Rockies	Loveland	Colorado
United States	San Juan Cancer Center	Montrose	Colorado
United States	Rocky Mountain Cancer Center	Pueblo	Colorado
United States	Yampa Valley Medical Center	Steamboat Springs	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Quality of Care	Use Quality of Care (QOC) questionnaire to determine if CARES intervention results in favorable QOC experience	From study start to study end (6 months)
Secondary	Patient Reported Outcomes	Use Patient Reported Outcomes (PRO) questionnaire o determine if CARES intervention results in improvements in distress, adaptive coping, and tobacco use	From study start to study end (6 months)