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

June 4, 2026 updated by: Roswell Park Cancer Institute

Financial Compass: A Pilot Feasibility Study of a Novel Intervention to Identify and Address Financial Hardship Among Cancer Patients

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14263
        • Recruiting
        • Roswell Park Cancer Institute
        • Principal Investigator:
          • Elizabeth Bouchard
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: discussion
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
Ancillary studies
Other Names:
  • Discuss
Experimental: Group I (Financial Compass intervention)
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
Ancillary studies
Other Names:
  • Discuss
Other: Financial Navigation
Receive the Financial Compass intervention
Other Names:
  • Financial Navigation Program
Active Comparator: Group II (usual care)
Patients receive usual care on study including medical consultations and supportive care.
Other: Best Practice
Receive usual care
Other Names:
  • standard of care
  • standard therapy
Other: Survey Administration
Ancillary studies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of the Financial Compass intervention (Aim 1)
Time Frame: 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.
Up to 2 years
Feasibility of the Financial Compass intervention (Aim 2)
Time Frame: 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.
Up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Roswell Park Cancer Institute

Investigators

  • Principal Investigator: Elizabeth Bouchard, Roswell Park Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 23, 2025

Primary Completion (Estimated)

February 25, 2027

Study Completion (Estimated)

February 25, 2027

Study Registration Dates

First Submitted

March 13, 2025

First Submitted That Met QC Criteria

March 19, 2025

First Posted (Actual)

March 26, 2025

Study Record Updates

Last Update Posted (Actual)

June 8, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I-4123124 (Other Identifier: Roswell Park Cancer Institute)
  • NCI-2025-01528 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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