CARE Tool Study Aim 3
Implement and Evaluate the CARE Tool in a Randomized Trial
2 other identifiers
interventional
430
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2026
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2025
CompletedFirst Posted
Study publicly available on registry
December 22, 2025
CompletedStudy Start
First participant enrolled
May 31, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2028
Study Completion
Last participant's last visit for all outcomes
July 31, 2028
April 30, 2026
April 1, 2026
2.2 years
December 18, 2025
April 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Patient's comprehensive score for financial toxicity (COST)
COST will be calculated by the sum of 11-items according to the validated measure. The items are scored on a 5-point Likert scale as follows: 0-Not at all, 1-A little bit, 2-Somewhat, 3-Quite a bit, and 4-Very much. Total possible range is 0-44 and the lower the score indicates greater financial toxicity. Scores will be summarized using means and 95% confidence intervals. Changes between timepoints will be analyzed by a two-sample t-test.
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
The measure of self-efficacy for communicating about care costs is adapted from the validated tool Decision Self-Efficacy Scale. The Decision Self-Efficacy Scale measures self-confidence or belief in one's abilities in decision making, including shared decision making. Three-items from the Decision Self-Efficacy Scale will be used to measure self-efficacy for communicating about care costs. The three items will be measured by a 3-point Likert scale as follows: 0-Not Confident, 2-A Little Confident, and 4-A lot confident. A higher score indicates greater self-efficacy in decision making. The total score will be calculated according to the validated measure. Scores will be summarized using means and 95% confidence intervals. Changes between timepoints will be analyzed by a two-sample t-test.
Completion of initial survey to completion of follow up survey (total estimated time is 3 months)
Patient's health insurance literacy measure (HILM) score
HILM score is calculated from a 6-item questionnaire according to the validated measure. Each item is measured by a 4-point Likert scale as follows: 1-Not at all confident, 2-Slightly confident, 3-Moderately confident, and 4-Very confident. Total possible range is 0-100 where 0 represents the lowest possible health insurance literacy level (more difficulty navigating insurance) and 100 represents the highest (more confidence in choosing/using insurance). Scores will be summarized using means and 95% confidence intervals. Changes between timepoints will be analyzed by a two-sample t-test.
Completion of initial survey to completion of follow up survey (total estimated time is 3 months)
Secondary Outcomes (4)
Patient's reported adherence to therapy & delayed care
Completion of initial survey to completion of follow up survey (total estimated time is 3 months)
Feasibility of Intervention Measure (FIM) - Adapted
At start of recruitment and at completion recruitment (total estimated time is 2 years)
Acceptability of Intervention Measure (AIM) - Adapted
At start of recruitment and at completion recruitment (total estimated time is 2 years)
Intervention Appropriateness Measure (IAM) - Adapted
At start of recruitment and at completion recruitment (total estimated time is 2 years)
Other Outcomes (1)
Organizational Readiness-Adapted
At start of recruitment and at completion recruitment (total estimated time is 2 years)
Study Arms (3)
Arm 1: Patients - Care Tool (Intervention)
EXPERIMENTALPatients 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 COMPARATORPatients 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
EXPERIMENTALParticipants 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
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.
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.
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.
Eligibility Criteria
You may qualify if:
- \- 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
You may not qualify if:
- 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
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Alton Memorial Hospital
Alton, Illinois, 62002, United States
Delbert Day Cancer Institute at Phelps Health
Rolla, Missouri, 65401, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ashley Housten, OTD, MSCI, OTR/L
Washington University School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2025
First Posted
December 22, 2025
Study Start (Estimated)
May 31, 2026
Primary Completion (Estimated)
July 31, 2028
Study Completion (Estimated)
July 31, 2028
Last Updated
April 30, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Final submission and deposit of the study data will occur at the end of data collection. Study data deposited will be available to the research community in perpetuity. Datasets underlying methodological publications will be shared at or prior to initial publication date.
- Access Criteria
- Researchers within the ACCERT consortium and those who provide a methodologically sound plan.
Participants can share their data for future research. Data such as age, sex, gender identity, race, and ethnicity, will be redacted to strip identifiers and minimize risks of unauthorized disclosure of personal identifiers. Common data elements (CDEs), identified by NCI and the ACCERT sites, will include identifiable information like zip code and county. Data from this optional survey could identify participants and may be shared with the NCI and ACCERT study teams . Publicly available documentation will include the study protocol, survey questions, codebook, univariate statistics, and study-level metadata. The codebook will include a description of each variable with the question number and text, variable name, variable label, value labels, and standard codes for missing values-including codes for non-applicable, "don't know," or prefer not to answer. We may share algorithms produced for analysis of CDEs. Users must agree to the conditions of use governing access to the data.