CARE Tool Study Aim 3
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Financial education information, CARE Tool, CARE Tool Training.
- Who it may be relevant to
- Registry conditions: Gynecologic Cancer, Prostate Cancer, Lung Cancer, Colorectal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Implement and Evaluate the CARE Tool in a Randomized Trial
Overview
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.
Interventions
- 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. - 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. - 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.
Primary outcome measures
- 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)]
Secondary outcome measures (4)
- Patient's reported adherence to therapy & delayed care [Time frame: Completion of initial survey to completion of follow up survey (total estimated time is 3 months)]
- Feasibility of Intervention Measure (FIM) - Adapted [Time frame: At start of recruitment and at completion recruitment (total estimated time is 2 years)]
- Acceptability of Intervention Measure (AIM) - Adapted [Time frame: At start of recruitment and at completion recruitment (total estimated time is 2 years)]
- Intervention Appropriateness Measure (IAM) - Adapted [Time frame: At start of recruitment and at completion recruitment (total estimated time is 2 years)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 3 centers
- Alton Memorial Hospital — Alton
- Delbert Day Cancer Institute at Phelps Health — Rolla
- Washington University School of Medicine — St Louis
Identifiers
NCT: NCT07296887 · 202601127 · U19CA291430