An interventional study of CARES Intervention in Lung Cancer, Head and Neck Cancer and Thyroid Cancer, sponsored by University of Colorado, Denver. Recruiting at 14 sites in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-02-05.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Health services research
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 320 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria Assessed During Screening:
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:
Exclusion Criteria Assessed During Screening:
Has already initiated curative treatment for the current episode of cancer.
Exclusion Criteria Assessed via Baseline Survey:
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
All participants will complete surveys to assess Quality of Care and Patient Reported Outcomes. Patients will receive a standardized list of resources.
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
Time to care
Number of days from diagnosis to treatment initiation and number of days from treatment initiation to treatment completion
Time frame: From study start to study end (6 months)
Quality of Care
Use Quality of Care (QOC) questionnaire to determine if CARES intervention results in favorable QOC experience
Time frame: From study start to study end (6 months)
Patient Reported Outcomes
Use Patient Reported Outcomes (PRO) questionnaire to determine if CARES intervention results in improvements in distress, adaptive coping, and tobacco use
Time frame: From study start to study end (6 months)
Plan to share: No
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University of Colorado, Denver