Implement and Evaluate the CARE Tool in a Randomized Trial
| Registry | NCT07296887 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, health services research |
| Enrollment | 430 (Estimated) |
| Sponsor | Washington University School of Medicine (Other); collaborators: National Cancer Institute (NCI) |
| Conditions | Gynecologic Cancer, Prostate Cancer, Lung Cancer, Colorectal Cancer |
| Interventions | Financial education information, CARE Tool, CARE Tool Training (Other) |
| Dates | start 2026-04-08, primary completion 2028-07-31 (estimated), completion 2028-07-31 (estimated), first posted 2025-12-22, last updated 2026-07-08 |
| Locations | 3 sites in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Gynecologic Cancer All trials for Prostate Cancer All trials of Financial education information All trials of CARE Tool
This study is a multi-site randomized trial to study the implementation of the CARE Tool and evaluate the CARE Tool. The CARE Tool is a web-based tool that gives people information about cancer care costs, health insurance, and resources to help with costs. Overall, the study aims to help patients with cancer overcome barriers they face navigating insurance and accessing financial resources.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Arm 1: Patients - Care Tool (Intervention) | Experimental | Other: CARE Tool | Patients will review the web-based CARE Tool after enrollment. Patients will complete a survey immediately after reviewing the website and a 3 month follow-up survey. |
| Arm 2: Patients - Standard of care financial education information (Control) | Active comparator | Other: Financial education information | Patients will review standard web-based financial education information after enrollment. Patients will complete a survey immediately after reviewing the website and a 3 month follow up survey. |
| Arm 3: Implementation champions - CARE training | Experimental | Other: CARE Tool Training | Participants who are members of the care team and have been identified as implementation champions will complete training on the CARE Tool and cost conversations. Participants will complete a survey after the training and a post-recruitment survey at the end of the trial. |
Sex: All, ages: 18 Years to any
Inclusion Criteria for Implementation champions: \- Members of the cancer care team (e.g., physicians, nurses, research coordinators, financial navigators, social workers) that work with patients receiving treatment for gynecologic, lung, prostate, or colorectal cancer; or members of the billing team and employee of Siteman Cancer Center, Barnes Jewish Hospital, Washington University, Delbert Day Cancer Institute at Phelps Health, or Alton Memorial Hospital Exclusion Criteria for Implementation champions: * Implementation champions are ineligible if they are non-employees of Siteman Cancer Center, Barnes Jewish Hospital, Washington University, Delbert Day Cancer Institute at Phelps Health, or Alton Memorial Hospital * Do not treat patients for gynecologic, prostate, lung, or colorectal cancer Inclusion Criteria for Patients: * Age 18 and over * Primary or recurrent diagnosis of gynecologic, prostate, lung, or colorectal cancer in the last 12 months * Receiving cancer treatment from Siteman Cancer Center, Delbert Day Cancer Institute at Phelps Health, or Alton Memorial Hospital * Self-reported ability to read and speak English Exclusion Criteria for Patients: * Under the age of 18 * Not diagnosed with gynecologic, prostate, lung, or colorectal cancer within the previous 12 months from recruitment * Not receiving care at Siteman Cancer Center, Delbert Day Cancer Institute at Phelps Health, or Alton Memorial Hospital * Cannot give consent due to cognitive or emotional barriers
| Facility | City | Country | Status |
|---|---|---|---|
| Alton Memorial Hospital | Alton, Illinois | United States | Recruiting |
| Delbert Day Cancer Institute at Phelps Health | Rolla, Missouri | United States | Recruiting |
| Washington University School of Medicine | St Louis, Missouri | United States | Recruiting |
NIH grants: U19CA291430