CARE Tool Study Aim 3
Part of paid clinical trials in Alton, Illinois.
- Sponsor
- Washington University School of Medicine
- Study ID
- NCT07296887
- Status
- Recruiting
Conditions
- Colorectal Cancer
- Gynecologic Cancer
- Lung Cancer
- Prostate Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Financial education information — OTHERStandard financial education resources will be provided to patients enrolled in the control arm. Financial education will be accessible via website and provided by the participating site.
- CARE Tool — OTHERThe CARE Tool is a web-based tool provided to patients after enrollment. The CARE Tool provides patients with individualized information about cancer care costs, health insurance, and resources to assist with costs.
- CARE Tool Training — OTHERMembers of the care team who have been identified as implementation champions will undergo training on cost conversations, how to use the CARE Tool, and how to implement the CARE Tool in their clinical workflow.
Study Details
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.
Key Dates
- Start date
- May 31, 2026
- Status verified
- Apr 2026
- Primary completion
- Jul 31, 2028
- Completion
- Jul 31, 2028
Study Design
- Enrollment
- 430 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- Experimental: Arm 1: Patients - Care Tool (Intervention)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.
- Active Comparator: Arm 2: Patients - Standard of care financial education information (Control)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.
- Experimental: Arm 3: Implementation champions - CARE trainingParticipants 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.
Primary Outcome Measure
Patient's comprehensive score for financial toxicity (COST) [ Time Frame: Completion of initial survey to completion of follow up survey (total estimated time is 3 months) ]
Central Contacts
- Ashley Housten, OTD, MSCI, OTR/L314-454-7958
- Krista Cooksey, BA314-935-7234
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Alton Memorial Hospital | Alton | Illinois | 62002 | Ashley Housten, OTD, MSCI, OTR/L (PRINCIPAL_INVESTIGATOR) |
| Delbert Day Cancer Institute at Phelps Health | Rolla | Missouri | 65401 | |
| Washington University School of Medicine | St Louis | Missouri | 63110 | Ashley Housten, OTD, MSCI, OTR/L (PRINCIPAL_INVESTIGATOR) Su-Hsin Chang, PhD (SUB_INVESTIGATOR) Mary Politi, PhD (SUB_INVESTIGATOR) Aimee James, PhD, MPH (SUB_INVESTIGATOR) Esther Lu, MS, PhD (SUB_INVESTIGATOR) Jennifer Irvin, MHSA, CHW-C (SUB_INVESTIGATOR) |
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