About this trial
This clinical trial compares the effect a financial intervention, called Financial Compass, to usual care in identifying and addressing financial hardship in patients with head and neck cancer. Previous research has shown that head and neck cancer patients experiencing financial hardship have decreased overall and cancer specific survival. Using a financial intervention, Financial Compass, may be more effective than usual care in identifying and addressing financial hardship in patients with head and neck cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
They have been diagnosed with head and neck cancer
Screen positive for financial hardship on the validated Comprehensive Score for Financial Toxicity (COST) measure
Are able to participate in English or Spanish
Disqualifiers
Adults unable to complete the process of informed consent
Adults whose primary language is not English or Spanish
Individuals who are not yet adults (i.e., infants, children, teenagers)
Unwilling or unable to follow protocol requirements
Trial design
Parallel
Treatments tested in this trial
Best Practice
Other interventionReceive usual care
Discussion
Other interventionAncillary studies
Financial Navigation
Other interventionReceive the Financial Compass intervention
Survey Administration
Other interventionAncillary studies
Treatment groups
Trial outcomes
Primary outcomes
Development of the Financial Compass intervention (Aim 1)
Will use stage 1A of the National Institutes of Health Stage Model to further develop the Financial Compass intervention. Will use data from in-depth interviews and collaborative engagement of advisory boards to refine the final Financial Compass intervention package. Will complete the Financial Compass intervention package. Will use the Person, Extended Family, Neighborhood (PEN)-3 model to guide integration of stakeholder feedback into the final Financial Compass intervention package. Will prepare summaries of key findings from the in-depth interviews to review with advisory board members. Themes in advisory board member feedback will be categorized using the main constructs of PEN-3 model in a 3 x 3 table, including (1) perceptions, (2) enablers, and (3) nurturers.
Feasibility of the Financial Compass intervention (Aim 2)
Will assess feasibility of the Financial Compass intervention among head and neck cancer patients. Will examine feasibility through demand (study enrollment rates, reasons for refusal), practicality (retention rates, engagement with intervention sessions/materials, reasons for study drop out), and acceptability (participant satisfaction with intervention materials and content). To assess acceptability, will administer the Acceptability of Intervention Measure (4 items), Intervention Appropriateness Measure (4 items) and Feasibility of Intervention Measure (4 items). The measures use a 5-point Likert scale where 1 = completely disagree and 5 = completely agree and have demonstrated strong psychometric properties. In the Financial Compass group, the measures will be summarized using the appropriate descriptive statistics, with estimates of enrollment and retention rates obtained with 90% confidence intervals.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.