Improving Care for Rural Patients With Solid Tumors
Part of paid clinical trials in Aurora, Colorado.
- Sponsor
- University of Colorado, Denver
- Study ID
- NCT04916990
- Status
- Recruiting
Conditions
- Bladder Cancer
- Breast Cancer
- Cervical Cancer
- Colon Cancer
- Head and Neck Cancer
- Lung Cancer
- Rectum Cancer
- Thyroid Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 99 Years
- Healthy Volunteers
- Not accepted
Interventions
- CARES Intervention — BEHAVIORALNurse 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
Study Details
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.
Key Dates
- Start date
- Sep 1, 2022
- Status verified
- Feb 2026
- Primary completion
- Jan 1, 2027
- Completion
- Jun 30, 2027
Study Design
- Enrollment
- 320 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- Active Comparator: CARES InterventionAll 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.
- No Intervention: Usual CareAll participants will complete surveys to assess Quality of Care and Patient Reported Outcomes. Patients will receive a standardized list of resources.
Primary Outcome Measure
Time to care [ Time Frame: From study start to study end (6 months) ]
Central Contacts
- Jennifer V Gonzalez, MS3037246278
- Tatiana Gerena, MPH303-724-5439
Locations (14)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Colorado Hospital | Aurora | Colorado | 80045 | Jennifer V Gonzalez |
| Memorial Hospital Central | Colorado Springs | Colorado | 80909 | Jennifer V Gonzalez |
| Memorial Hospital North | Colorado Springs | Colorado | 80920 | Jennifer V Gonzalez |
| Poudre Valley Hospital | Fort Collins | Colorado | 80524 | Jennifer V Gonzalez Steven Schuster, MD (PRINCIPAL_INVESTIGATOR) |
| SCL- St. Mary's Medical Center | Grand Junction | Colorado | 81501 | |
| VA Western Colorado Health Care System | Grand Junction | Colorado | 81501 | |
| Greeley Campus | Greeley | Colorado | 80634 | Jennifer V Gonzalez Steven Schuster, MD (PRINCIPAL_INVESTIGATOR) |
| Highlands Ranch Hospital | Highlands Ranch | Colorado | 80129 | Jennifer V Gonzalez Ryan Lanning, MD (PRINCIPAL_INVESTIGATOR) Poojitha Valasareddy, MD (PRINCIPAL_INVESTIGATOR) |
| Medical Center of the Rockies | Loveland | Colorado | 80538 | Jennifer V Gonzalez Steven Schuster, MD (PRINCIPAL_INVESTIGATOR) |
| San Juan Cancer Center | Montrose | Colorado | 81401 | Jennifer P Gonzalez |
| Rocky Mountain Cancer Center | Pueblo | Colorado | 81003 | Jennifer V Gonzalez |
| UCHealth - Parkview medical Center | Pueblo | Colorado | 81003 | Evelinn Borrayo, MD (PRINCIPAL_INVESTIGATOR) |
| Yampa Valley Medical Center | Steamboat Springs | Colorado | 80487 | Jennifer V Gonzalez Steven Schuster, MD (PRINCIPAL_INVESTIGATOR) |
| Huntsman Cancer Institute at the University of Utah | Salt Lake City | Utah | 84112 |
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