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Financial Navigation Program for Cancer (CREDIT Trial)

N/A

Recruiting

Led By Veena Shankaran

Research Sponsored by Southwest Oncology Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have a Zubrod performance status of 0-2

Patients must complete the baseline patient reported outcomes (PRO) questionnaires prior to registration and must be able to complete questionnaires in English or Spanish

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a financial navigation program to help cancer patients and their spouses understand and manage the financial aspects of cancer care. The goal is to reduce financial worries and improve quality of life.

Who is the study for?

This trial is for adult cancer patients with metastatic solid tumors or blood cancers starting treatment within 60 days of diagnosis, and their spouses who live together and can complete questionnaires in English or Spanish. Excluded are those on hospice care, with indolent diseases under observation only, or diagnosed with a secondary malignancy within the last 24 months unless it's specific non-active skin cancers.

What is being tested?

The study tests a financial navigation program designed to help cancer patients and their spouses manage treatment costs. It involves education, patient navigation support, quality-of-life assessments, and completing questionnaires to evaluate the program's effectiveness in reducing financial stress.

What are the potential side effects?

There are no medical side effects as this is not a drug trial; however participants may experience emotional discomfort discussing personal finances or when dealing with sensitive information such as credit reports.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and am up and about more than 50% of my waking hours.

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I have completed the required questionnaires in English or Spanish before signing up.

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I am 18 years old or older.

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I will start cancer treatment within 30 days of signing up.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Patient financial hardship

Secondary study objectives

Emergency department/hospital use

Financial worry

Quality of life: patient

+2 more

Other study objectives

Community/clinic assistance

Qualitative assessment of the intervention

Quality of life: spouse/partner caregiver

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group II (financial navigation intervention)Experimental Treatment4 Interventions

Patients receive financial literacy training consisting of watching online educational videos over 2-8 minutes. Patients also meet with CENTS counselor and PAF case manager over approximately 1 hour every month for 6 months (with each group). Patients also complete questionnaires over 30-60 minutes about education, employment, finances (assets, debt), insurance, and quality of life (financial worry) and have credit reports assessed at baseline and 3, 6, and 12 months. If participating, spouse/partner caregivers will receive the same intervention, and will complete questionnaires and have credit reports assessed at baseline and 3, 6, and 12 months.

Group II: Group I (usual care)Active Control3 Interventions

Patients receive financial literacy training consisting of watching online educational videos over 2-8 minutes. Patients also complete questionnaires over 30-60 minutes about education, employment, finances (assets, debt), insurance, and quality of life (financial worry) and have credit reports assessed at baseline and 3, 6, and 12 months. If participating, spouse/partner caregivers will receive the same intervention, and will complete questionnaires and have credit reports assessed at baseline and 3, 6, and 12 months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Patient Navigation

2017

Completed Phase 2

~38910

0 / 4Eligibility criteria met