Financial Compass for Head and Neck Cancers

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Roswell Park Cancer Institute

Disqualifiers: Non-English/Spanish speakers, Minors, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

44 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on financial intervention, so it's unlikely that medication changes are required.

How does the treatment Financial Compass differ from other treatments for head and neck cancers?

Financial Compass is unique because it focuses on addressing the financial challenges (financial toxicity) faced by head and neck cancer patients, rather than directly treating the cancer itself. This approach aims to reduce financial stress and improve the overall quality of life for patients and their caregivers. ^{1 2 3 4 5}

Research Team

Elizabeth Bouchard

Principal Investigator

Roswell Park Cancer Institute

Eligibility Criteria

This trial is for head and neck cancer patients who are facing financial hardship. The study aims to see if a special program called Financial Compass can help them better than the usual care they receive.

Inclusion Criteria

Screen positive for financial hardship on the validated Comprehensive Score for Financial Toxicity (COST) measure

I have been diagnosed with head and neck cancer.

I can communicate in English or Spanish.

Exclusion Criteria

Unwilling or unable to follow protocol requirements

English or Spanish is not my primary language.

I am unable to understand or sign the consent form by myself.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Development

Participants complete interviews and take part in advisory boards to develop and refine the Financial Compass intervention

Up to 2 years

Randomized Control Trial

Patients are randomized to receive either the Financial Compass intervention or usual care

12 weeks

Follow-up

Participants are monitored for the efficacy and feasibility of the Financial Compass intervention

12 weeks

Treatment Details

Interventions

• Financial Compass

Trial Overview The trial tests whether the Financial Compass program, which includes best practices, surveys, discussions, and financial navigation interviews, is more effective in identifying and addressing financial issues compared to standard support.

Participant Groups

Group I: Aim 3 Group I (Financial Compass intervention) Experimental Treatment 2 Interventions

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: Aim 2 (discussion) Experimental Treatment 1 Intervention

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.

Group III: Aim 1 (interview) Experimental Treatment 1 Intervention

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

Group IV: Aim 3 Group II (usual care) Active Control 2 Interventions

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

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

References

1. United States pubmed.ncbi.nlm.nih.gov

Financial toxicity among head and neck cancer patients and their caregivers: A cross-sectional pilot study. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Financial Counseling Is Associated with Reduced Financial Difficulty Scores in Head and Neck Cancer Patients Treated with Radiation Therapy. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Understanding financial toxicity in head and neck cancer survivors. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Determinants of Patient-Centered Financial Stress in Patients With Locally Advanced Head and Neck Cancer. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Financial Vulnerability: A Case Study Involving a Patient With Head and Neck Cancer. [2020]