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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA046934 | U.S. NIH Grant/Contract | View source | |
| R01CA254730-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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 solid tumors (ex: lung, head, neck, thyroid, cervical, breast, bladder, colon, and rectal cancers) in rural patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CARES Intervention | Active Comparator | 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. |
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| Usual Care | No Intervention | All participants will complete surveys to assess Quality of Care and Patient Reported Outcomes. Patients will receive a standardized list of resources. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CARES Intervention | Behavioral | 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 |
| 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) |
| 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 |
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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, 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.
Inclusion Criteria Confirmed via Baseline Survey:
Rural and medically underserved, defined as meeting the following criteria:
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, St. Mary's or Parkview Medical Center.
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer V Gonzalez, MS | Contact | 3037246278 | jennifer.villalobosgonzalez@cuanschutz.edu | |
| Tatiana Gerena, MPH | Contact | 303-724-5439 | tatiana.gerena@cuanschutz.edu |
| Name | Affiliation | Role |
|---|---|---|
| Evelinn Borrayo, PhD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Hospital | Recruiting | Aurora | Colorado | 80045 | United States |
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Use Patient Reported Outcomes (PRO) questionnaire to determine if CARES intervention results in improvements in distress, adaptive coping, and tobacco use
| From study start to study end (6 months) |
| Memorial Hospital Central | Recruiting | Colorado Springs | Colorado | 80909 | United States |
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| Memorial Hospital North | Recruiting | Colorado Springs | Colorado | 80920 | United States |
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| Poudre Valley Hospital | Recruiting | Fort Collins | Colorado | 80524 | United States |
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| SCL- St. Mary's Medical Center | Recruiting | Grand Junction | Colorado | 81501 | United States |
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| VA Western Colorado Health Care System | Recruiting | Grand Junction | Colorado | 81501 | United States |
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| Greeley Campus | Recruiting | Greeley | Colorado | 80634 | United States |
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| Highlands Ranch Hospital | Recruiting | Highlands Ranch | Colorado | 80129 | United States |
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| Medical Center of the Rockies | Recruiting | Loveland | Colorado | 80538 | United States |
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| San Juan Cancer Center | Recruiting | Montrose | Colorado | 81401 | United States |
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| Rocky Mountain Cancer Center | Recruiting | Pueblo | Colorado | 81003 | United States |
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| UCHealth - Parkview medical Center | Recruiting | Pueblo | Colorado | 81003 | United States |
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| Yampa Valley Medical Center | Recruiting | Steamboat Springs | Colorado | 80487 | United States |
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| Huntsman Cancer Institute at the University of Utah | Recruiting | Salt Lake City | Utah | 84112 | United States |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D013964 | Thyroid Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D001943 | Breast Neoplasms |
| D001749 | Urinary Bladder Neoplasms |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D004700 | Endocrine System Diseases |
| D013959 | Thyroid Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014571 | Urologic Neoplasms |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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