Implement and Evaluate the CARE Tool in a Randomized Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 430
- Locations
- 3
- Primary Endpoint
- Patient's comprehensive score for financial toxicity (COST)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: CARE Tool (Other)
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.
Intervention: Financial education information (Other)
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.
Intervention: CARE Tool Training (Other)
Outcomes
Primary Outcomes
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)
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.
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)
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.
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)
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.
Secondary Outcomes
- Intervention Appropriateness Measure (IAM) - Adapted(At start of recruitment and at completion recruitment (total estimated time is 2 years))
- 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))