Lung Cancer Clinical Trial

Improving Care for Rural Patients With Solid Tumors

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 Lung Cancer and Head and Neck Cancer patients.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria Assessed During Screening:

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, or SCL-St. Mary's.
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.
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

Inclusion Criteria Confirmed via Baseline Survey:

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

Exclusion Criteria Assessed During Screening:

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, or St. Mary's.
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.
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,

Has already initiated curative treatment for the current episode of cancer.

Exclusion Criteria Assessed via Baseline Survey:

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

Study is for people with:

Lung Cancer

Estimated Enrollment:

320

Study ID:

NCT04916990

Recruitment Status:

Recruiting

Sponsor:

University of Colorado, Denver

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There are 11 Locations for this study

See Locations Near You

University of Colorado Hospital
Aurora Colorado, 80045, United States More Info
Jennifer V Gonzalez
Contact
[email protected]
Memorial Hospital Central
Colorado Springs Colorado, 80909, United States More Info
Jennifer V Gonzalez
Contact
[email protected]
Memorial Hospital North
Colorado Springs Colorado, 80920, United States More Info
Jennifer V Gonzalez
Contact
[email protected]
Poudre Valley Hospital
Fort Collins Colorado, 80524, United States More Info
Jennifer V Gonzalez
Contact
[email protected]
Steven Schuster, MD
Principal Investigator
SCL- St. Mary's Medical Center
Grand Junction Colorado, 81501, United States More Info
Marty Jacobsen
Contact
970-298-1822
[email protected]
Greeley Campus
Greeley Colorado, 80634, United States More Info
Jennifer V Gonzalez
Contact
[email protected]
Steven Schuster, MD
Principal Investigator
Highlands Ranch Hospital
Highlands Ranch Colorado, 80129, United States More Info
Jennifer V Gonzalez
Contact
[email protected]
Ryan Lanning, MD
Principal Investigator
Poojitha Valasareddy, MD
Principal Investigator
Medical Center of the Rockies
Loveland Colorado, 80538, United States More Info
Jennifer V Gonzalez
Contact
[email protected]
Steven Schuster, MD
Principal Investigator
San Juan Cancer Center
Montrose Colorado, 81401, United States More Info
Jennifer P Gonzalez
Contact
[email protected]
Rocky Mountain Cancer Center
Pueblo Colorado, 81003, United States More Info
Jennifer V Gonzalez
Contact
[email protected]
Yampa Valley Medical Center
Steamboat Springs Colorado, 80487, United States More Info
Jennifer V Gonzalez
Contact
[email protected]
Steven Schuster, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Estimated Enrollment:

320

Study ID:

NCT04916990

Recruitment Status:

Recruiting

Sponsor:


University of Colorado, Denver

How clear is this clinincal trial information?

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