A Financial Intervention (Financial Compass) to Identify and Address Financial Hardship Among Head and Neck Cancer Patients, Financial Compass Trial

NCT06896695 | Recruiting

• 2 other identifiers: I-4123124NCI-2025-01528
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to 2 years

• 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.

  Up to 12 weeks

Study Arms (3)

discussion

OTHER

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.

Other: Discussion

Group I (Financial Compass intervention)

EXPERIMENTAL

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.

Other: Discussion; Other: Financial Navigation

Group II (usual care)

ACTIVE COMPARATOR

Patients receive usual care on study including medical consultations and supportive care.

Other: Best Practice; Other: Survey Administration

Interventions

Best Practice OTHER

Receive usual care

Also known as: standard of care, standard therapy

Group II (usual care)

Discussion OTHER

Ancillary studies

Also known as: Discuss

Group I (Financial Compass intervention); discussion

Financial Navigation OTHER

Receive the Financial Compass intervention

Also known as: Financial Navigation Program

Group I (Financial Compass intervention)

Survey Administration OTHER

Ancillary studies

Group II (usual care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

RECRUITING

MeSH Terms

Interventions

Practice Guidelines as Topic; Standard of Care

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care

Study Officials

• Elizabeth Bouchard

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 26, 2025
• Study Start: September 23, 2025
• Primary Completion (Estimated): February 25, 2027
• Study Completion (Estimated): February 25, 2027
• Last Updated: June 8, 2026

Record last verified: 2026-06

Locations

US (1)