Clinical trial NCT06896695: A Financial Intervention (Financial Compass) to Identify and Address Financial Hardship Among Head and Neck Cancer Patients, Financial Compass Trial
Official title: Financial Compass: A Pilot Feasibility Study of a Novel Intervention to Identify and Address Financial Hardship Among Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Carcinoma
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2025-03-26
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cancer-related financial hardship (Aim 1)
timeFrame: Up to 2 years
measure: Development of the Financial Compass intervention (Aim 2)
timeFrame: Up to 2 years
measure: Feasibility of the Financial Compass intervention (Aim 3)
timeFrame: Up to 12 weeks
measure: Efficacy of the Financial Compass intervention (Aim 3)
timeFrame: Up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Elizabeth Bouchard
role: PRINCIPAL_INVESTIGATOR
References: