Ignite Creation Date:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2025-12-29 @ 8:09 AM
Study NCT ID:
NCT06896695
Status:
RECRUITING
Last Update Posted:
2025-10-31
First Post:
2025-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Financial Intervention (Financial Compass) to Identify and Address Financial Hardship Among Head and Neck Cancer Patients, Financial Compass Trial
Sponsor:
Roswell Park Cancer Institute
Organization:
Study Overview
Official Title:
Financial Compass: A Pilot Feasibility Study of a Novel Intervention to Identify and Address Financial Hardship Among Cancer Patients
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: