CARE Tool Study Aim 3

NCT ID: NCT07296887

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

430 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2028-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Gynecologic Cancer Prostate Cancer Lung Cancer Colorectal Cancer

Keywords

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Insurance Insurance coverage Cancer Cost of medical care Financial toxicity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patient participants will be randomized to one of two arms, the CARE Tool or standard financial education information, and participate in surveys. Participants enrolled as site staff and members of the care team will complete a training on the CARE Tool and participate in surveys.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

CARE Tool

Intervention Type OTHER

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.

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.

Group Type ACTIVE_COMPARATOR

Financial education information

Intervention Type OTHER

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.

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.

Group Type EXPERIMENTAL

CARE Tool Training

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\- 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


* 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

* 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


* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ashley Housten, OTD, MSCI, OTR/L

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Alton Memorial Hospital

Alton, Illinois, United States

Site Status

Delbert Day Cancer Institute at Phelps Health

Rolla, Missouri, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

Central Contacts

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Ashley Housten, OTD, MSCI, OTR/L

Role: CONTACT

Phone: 314-454-7958

Email: [email protected]

Krista Cooksey, BA

Role: CONTACT

Phone: 314-935-7234

Email: [email protected]

Facility Contacts

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Ashley Housten, OTD, MSCI, OTR/L

Role: primary

Casey Burton, Ph.D.

Role: primary

Ashley Housten, OTD, MSCI, OTR/L

Role: primary

Krista Cooksey, BA

Role: backup

Related Links

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http://siteman.wustl.edu

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Other Identifiers

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U19CA291430

Identifier Type: NIH

Identifier Source: secondary_id

View Link

25-x479

Identifier Type: -

Identifier Source: org_study_id