Rural Lung and Head and Neck Cancer Intervention

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Improving the Timeliness and Quality of Care for Rural Lung and Head-and-Neck Cancer Patients

Conditions
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Lung Cancer, Head and Neck Cancer

Intervention / Treatment
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* Behavioral: CARES Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 University of Colorado Hospital (UCH) , SCL-St. Mary's Medical Center, or Rocky Mountain Cancer Centers (RMCC) in Pueblo, CO. Resides in any of the rural counties served by one of the collaborating sites 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 LC and/or HNC treatments (surgery, radiation therapy, chemotherapy, or a combination of those modalities, including neoadjuvant and adjuvant therapy) Diagnosed with 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 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: Exclusion Criteria Assessed During Screening: Children under 18 years old Individuals who do not speak English or Spanish Individuals not receiving cancer treatment at one of the collaborating sites Diagnosed with primary cancer other than LC and/or HNC, or other type of LC and/or HNC not listed in the inclusion criteria Diagnosed with a type of LC or HNC 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CARES Intervention<br>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<br>* 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<br>|
| No Intervention: Usual Care<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) |