Colorectal Cancer, Gynecologic Cancer, Lung Cancer, Prostate Cancer
Conditions
Keywords
Insurance, Insurance coverage, Cancer, Cost of medical care, Financial toxicity
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.
Interventions
OTHERFinancial 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.
OTHERCARE 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.
OTHERCARE 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.
Sponsors
Washington University School of Medicine
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient's comprehensive score for financial toxicity (COST) | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient's reported adherence to therapy & delayed care | Completion of initial survey to completion of follow up survey (total estimated time is 3 months) | 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. . |
| Feasibility of Intervention Measure (FIM) - Adapted | At start of recruitment and at completion recruitment (total estimated time is 2 years) | 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. |
| Acceptability of Intervention Measure (AIM) - Adapted | At start of recruitment and at completion recruitment (total estimated time is 2 years) | 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. |
| Intervention Appropriateness Measure (IAM) - Adapted | At start of recruitment and at completion recruitment (total estimated time is 2 years) | 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. |
Countries
United States
Contacts
CONTACTAshley Housten, OTD, MSCI, OTR/L
CONTACTKrista Cooksey, BA
PRINCIPAL_INVESTIGATORAshley Housten, OTD, MSCI, OTR/L
Washington University School of Medicine
Outcome results
None listed