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

Roswell Park Comprehensive Cancer Center

Status: Enrolling

Conditions: Head and Neck Carcinoma

Treatments: Other: Financial Navigation; Other: Survey Administration; Other: Interview; Other: Best Practice; Other: Discussion

Study type: Interventional

Funder types: Other

Identifiers

NCT06896695

NCI-2025-01528 (Registry Identifier)

I-4123124 (Other Identifier)

Details and patient eligibility

About

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.

Full description

PRIMARY OBJECTIVES:

I. Examine head and neck cancer patients' experiences with financial hardship to understand barriers across the socioeconomic spectrum and inform intervention refinement. (Aim 1) II. Apply community-engaged intervention mapping to tailor the Financial Compass intervention to address the needs and experiences of head and neck cancer patients. (Aim 2) III. Conduct a pilot randomized control trial of Financial Compass to assess feasibility, acceptability and preliminary efficacy among head and neck cancer patients. (Aim 3)

OUTLINE:

AIM 1: Patients complete interviews on study for Financial Compass intervention development and refinement.

AIM 2: 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 3: Patients are randomized to 1 of 2 groups.

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 4 patient groups

Aim 1 (interview)

Other group

Description:

Patients complete interviews on study for Financial Compass intervention development and refinement.

Treatment:

Other: Interview

Aim 2 (discussion)

Other group

Description:

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.

Treatment:

Other: Discussion

Aim 3 Group I (Financial Compass intervention)

Experimental group

Description:

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.

Treatment:

Other: Survey Administration

Other: Financial Navigation

Aim 3 Group II (usual care)

Active Comparator group

Description:

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

Treatment:

Other: Best Practice

Other: Survey Administration