CARE Tool Study Aim 3

Implement and Evaluate the CARE Tool in a Randomized Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Gynecologic Cancer; Colorectal Cancer; Lung Cancer; Prostate Cancer
• Intervention / Treatment: Other: CARE Tool; Other: Financial education information; Other: CARE Tool Training

• Study Type: Interventional
• Enrollment (Estimated): 430
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ashley Housten, OTD, MSCI, OTR/L; Phone Number: 314-454-7958; Email: ahousten@wustl.edu
• Study Contact Backup: Name: Krista Cooksey, BA; Phone Number: 314-935-7234; Email: kcooksey@wustl.edu

Study Locations

• United States
  • Illinois
    • Alton, Illinois, United States, 62002
      • Not yet recruiting
      • Alton Memorial Hospital
      • Contact: Ashley Housten, OTD, MSCI, OTR/L; Phone Number: 314-454-7958; Email: ahousten@wustl.edu
      • Principal Investigator: Ashley Housten, OTD, MSCI, OTR/L
  • Missouri
    • Rolla, Missouri, United States, 65401
      • Not yet recruiting
      • Delbert Day Cancer Institute at Phelps Health
      • Contact: Casey Burton, Ph.D.; Phone Number: 573-458-7043; Email: cburton@phelpshealth.org
    • St Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University School of Medicine
      • Sub-Investigator: Mary Politi, PhD
      • Contact: Ashley Housten, OTD, MSCI, OTR/L; Phone Number: 314-454-7958; Email: ahousten@wustl.edu
      • Contact: Krista Cooksey, BA; Phone Number: 314-935-7234; Email: kcooksey@wustl.edu
      • Principal Investigator: Ashley Housten, OTD, MSCI, OTR/L
      • Sub-Investigator: Su-Hsin Chang, PhD
      • Sub-Investigator: Aimee James, PhD, MPH
      • Sub-Investigator: Esther Lu, MS, PhD
      • Sub-Investigator: Jennifer Irvin, MHSA, CHW-C

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	Other: 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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's reported adherence to therapy & delayed care	Patient reported delayed care will be calculated from responses to three-items adapted from the National Health Interview Survey (NHIS). The three items have four categorical answers: Yes, No, I don't know, and Prefer not to answer. Scores will be summarized using frequencies. Changes between timepoints will be analyzed using sample proportions and 95% Clopper-Pearson Confidence Intervals. Changes between timepoints will be analyzed by a Pearson Chi-square test. .	Completion of initial survey to completion of follow up survey (total estimated time is 3 months)
Feasibility of Intervention Measure (FIM) - Adapted	FIM will be assessed by implementation champions' response to a single item from the FIM measure on the initial and follow up survey. FIM is measured by a 5-point Likert scale: 1-Completely disagree, 2-Disagree, 3-Neither agree nor Disagree, 4-Agree, or 5-Completely agree. A higher score indicates greater feasibility of the intervention in practice. Outcome will be summarized using means and 95% confidence intervals. Changes between surveys will be analyzed by a two-sample t-test.	At start of recruitment and at completion recruitment (total estimated time is 2 years)
Acceptability of Intervention Measure (AIM) - Adapted	AIM will be assessed by implementation champions' response to a single item from the AIM measure on the initial and follow up survey. AIM is measured by a 5-point Likert scale: 1-Completely disagree, 2-Disagree, 3-Neither agree nor Disagree, 4-Agree, or 5-Completely agree. A higher score indicates greater acceptability by subjects of the intervention. Outcome will be summarized using means and 95% confidence intervals. Changes between surveys will be analyzed by a two-sample t-test.	At start of recruitment and at completion recruitment (total estimated time is 2 years)
Intervention Appropriateness Measure (IAM) - Adapted	IAM will be assessed by implementation champions' response to a single item from the IAM measure on the initial and follow up survey. IAM is measured by a 5-point Likert scale: 1-Completely disagree, 2-Disagree, 3-Neither agree nor Disagree, 4-Agree, or 5-Completely agree. A higher score indicates greater appropriateness of the intervention. Outcome will be summarized using means and 95% confidence intervals. Changes between surveys will be analyzed by a two-sample t-test.	At start of recruitment and at completion recruitment (total estimated time is 2 years)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Organizational Readiness-Adapted	Organizational readiness will be assessed by implementation champions' response to 6 items adapted from the MORE measure for organizational readiness and 3 items adapted from the organizational readiness for implementing change (ORIC) measure. MORE items are measured on a 4-point Likert scale: 1-Not willing, 2-Somewhat willing, 3-Willing, and 4-Very willing. A higher score indicates greater organizational readiness. ORIC items are measured on a 5-point Likert scale: 1-Disagree, 2-Somewhat Disagree, 3-Neither agree nor Disagree, 4-Somewhat Agree, or 5-Agree. A higher score indicates greater organizational readiness to implement change. Changes between surveys will be analyzed by a two-sample t-test.	At start of recruitment and at completion recruitment (total estimated time is 2 years)

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Ashley Housten, OTD, MSCI, OTR/L, Washington University School of Medicine

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Estimated): May 31, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: December 18, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Actual): December 22, 2025

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Cancer; Financial toxicity; Insurance; Insurance coverage; Cost of medical care
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Intestinal Diseases; Behavioral Symptoms; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Colonic Diseases; Stress, Psychological; Behavior; Financial Stress; Neoplasms; Prostatic Neoplasms; Lung Neoplasms; Colorectal Neoplasms; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care
• Other Study ID Numbers: 202601127; U19CA291430 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing 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.
• IPD Sharing Access Criteria: Researchers within the ACCERT consortium and those who provide a methodologically sound plan.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No