Recruiting

CARE Tool

Sponsor:

Washington University School of Medicine

Code:

NCT07296887

Conditions

Gynecologic Cancer

Prostate Cancer

Lung Cancer

Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Financial education information

CARE Tool

CARE Tool Training

Study Details

Brief summary:

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.

Conditions

Gynecologic Cancer

Prostate Cancer

Lung Cancer

Colorectal Cancer

Study ID

NCT07296887

Start date

Apr 8, 2026

Status verified date

Jul, 2026

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Jul 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

430 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

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 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.

Interventions

Financial education information

Standard 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

The 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

Members 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.

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) ]
  • Patient's score of self-efficacy for communicating about care costs measured with the Decision Self-Efficacy Scale [ Time Frame: Completion of initial survey to completion of follow up survey (total estimated time is 3 months) ]
  • Patient's health insurance literacy measure (HILM) score [ Time Frame: Completion of initial survey to completion of follow up survey (total estimated time is 3 months) ]

Central Contacts and Locations

Central contacts

Ashley Housten, OTD, MSCI, OTR/L

314-454-7958ahousten@wustl.edu

Krista Cooksey, BA

314-935-7234kcooksey@wustl.edu

Locations

Alton Memorial Hospital

Recruiting

Alton, Illinois, United States, 62002

Contacts

Ashley Housten, OTD, MSCI, OTR/L

314-454-7958ahousten@wustl.edu

Principal Investigator:

Ashley Housten, OTD, MSCI, OTR/L

Delbert Day Cancer Institute at Phelps Health

Recruiting

Rolla, Missouri, United States, 65401

Contacts

Casey Burton, Ph.D.

573-458-7043cburton@phelpshealth.org

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Ashley Housten, OTD, MSCI, OTR/L

314-454-7958ahousten@wustl.edu

Krista Cooksey, BA

314-935-7234kcooksey@wustl.edu

Principal Investigator:

Ashley Housten, OTD, MSCI, OTR/L

More Information

Sponsor

Washington University School of Medicine

Last update posted

Jul 8, 2026

Last verified

Jul, 2026

Keywords

  • Insurance
  • Insurance coverage
  • Cancer
  • Cost of medical care
  • Financial toxicity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-07-08.