CARES Intervention for the Improvement of Timeliness and Quality of Care in Rural Cancer Patients with Solid Tumors
This clinical trial studies how useful a mental health counseling program called CARES is compared to usual care in improving the timeliness and quality of care in rural cancer patients with solid tumors. Cancer patients often suffer from a lot of stress and emotional distress while they undergo an intense and harsh cancer treatment. However, the usual care they receive for their distress is limited and mostly offered when patients are in crisis. CARES program targets emotional distress and includes a maximum of 10 navigations and 10 counseling sessions delivered over approximately a 6-month period. The CARES program may help rural cancer patients with solid tumors better manage stress and emotions, such as feeling anxious or depressed, while the patient undergoes cancer treatment.
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) Aurora, UCH-Highlands Ranch, University of Colorado (UC) Health North, UC Health South- UC Health Memorial Hospital, San Juan Cancer Center, Rocky Mountain Cancer Centers (RMCC) -Pueblo, Sisters of Charity of Leavenworth (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, UC Health South- UC Health Memorial Hospital, San Juan Cancer Center, RMCC-Pueblo, SCL-St. Mary’s 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
- Stage of diagnosis for SCLC (limited versus [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
- 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 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 UCH (Aurora, Highlands Ranch, UC Health North, UC Health Memorial Hospital), San Juan Cancer Center, RMCC-Pueblo, St. Mary’s or Parkview Medical Center
- Diagnosed with primary cancer other than LC, HNC, BC, CC, CRC, and/or BLC or other type of LC and/or HNC not listed in the inclusion criteria
- Diagnosed with a type of LC, HN, BC, CC, CRC, and/or BLC 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) * 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
- 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) * 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
- Likely inability to track the individual over time (e.g. no permanent address at the time of consent)
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04916990.
Locations matching your search criteria
United States
Colorado
Aurora
Colorado Springs
Fort Collins
Grand Junction
Greeley
Highlands Ranch
Loveland
Montrose
Pueblo
PRIMARY OBJECTIVE:
I. Assess if the CARES intervention significantly improves time to treatment initiation after diagnosis and time to treatment completion compared to usual practices for lung cancer (LC), head and neck cancer (HNC), breast cancer (BC), cervical (CC), colon and rectum (CRC), and, bladder cancer (BLC) patients.
SECONDARY OBJECTIVE:
I. Assess if the CARES intervention significantly improves healthcare delivery, mainly quality of care (QOC) and
patient-reported outcomes (PROs) as secondary outcomes, compared to usual care practices to support LC, HNC, BC, CC, CRC, and BLC patients.
TERTIARY/EXPLORATORY OBJECTIVE:
I. Assess the pragmatic implementation and scalability of the CARES intervention by evaluating the effectiveness of its strategies and modifying the intervention accordingly for wide dissemination.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (CARES INTERVENTION): Patients receive CARES intervention consisting of up to 10 navigation and 10 counseling sessions over 6 months.
ARM II (ENHANCED USUAL CARE): Patients receive enhanced usual care.
Trial PhaseNo phase specified
Trial Typehealth services research
Lead OrganizationUCHealth University of Colorado Hospital
Principal InvestigatorEvelinn Borrayo
- Primary ID21-2666
- Secondary IDsNCI-2021-03968
- ClinicalTrials.gov IDNCT04916990