Head and Neck Carcinoma
Conditions
Brief summary
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.
Detailed description
PRIMARY OBJECTIVES: I. Apply community-engaged intervention mapping to tailor the Financial Compass intervention to address the needs and experiences of head and neck cancer patients. (Aim 1) II. Conduct a pilot randomized control trial of Financial Compass to assess feasibility, acceptability and preliminary efficacy among head and neck cancer patients. (Aim 2) OUTLINE: AIM 1: Participants take part in a community advisory board and/or a health care delivery advisory board on study to discuss, develop and refine the Financial Compass intervention. AIM 2: Screening questionnaire to identify financial concerns. Subjects will be randomized to : GROUP I: Patients receive the Financial Compass intervention on study including a patient needs assessment, a tailored care pathway and weekly individualized navigation and support to access resources. GROUP II: Patients receive usual care on study including medical consultations and supportive care. After completion of study intervention, patients are followed up at week 12.
Interventions
OTHERBest Practice
Receive usual care
OTHERDiscussion
Ancillary studies
OTHERFinancial Navigation
Receive the Financial Compass intervention
OTHERSurvey Administration
Ancillary studies
Sponsors
Roswell Park Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Development of the Financial Compass intervention (Aim 1) | Up to 2 years | 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) | Up to 12 weeks | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORElizabeth Bouchard
Roswell Park Cancer Institute
Outcome results
None listed