Longitudinal Screening for Financial Hardship to Improve Outcomes in Patients With Advanced Cancer (PROOF)

Alliance Foundation Trials

Status: Enrolling

Conditions: Metastatic Cancer; Advanced Cancer

Treatments: Other: Financial Hardship Screening; Other: Enhanced Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT06963723

A232403

Details and patient eligibility

About

The study aims to determine whether monthly remote digital financial hardship screening among adults with advanced/metastatic cancer, undergoing outpatient systemic therapy with non-curative intent, improves patient-centered outcomes, including financial worry, health-related quality of life (HRQoL), symptom burden, patient-reported cancer treatment adherence, and exploratory outcomes of overall survival, patient-reported economic burden, patient-reported support received, patient-reported financial coping strategies, and health insurance literacy.

Full description

Financial hardship is a common problem that affects patients treated for advanced cancer and leads to poor outcomes related to financial worry, health related quality of life (HRQoL), symptom burden, treatment adherence, and overall survival. Prior studies have shown that financial navigation may be an effective strategy to attenuate the impact of financial hardship. However, patients and clinicians have identified communication as a key barrier that prevents patients from being connected to sources of financial assistance. To address this critical gap in patient care, and based on strong preliminary data that financial hardship screening may improve patient outcomes, this financial hardship screening intervention will help connect patients to financial navigation resources. It is hypothesized that by connecting patients experiencing financial hardship with financial navigation resources, this intervention will lead to improved patient-centered outcomes.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Minimum age of 21
2. Understands English and/or Spanish
3. Has a diagnosis of advanced/metastatic cancer
4. Currently undergoing systemic therapy (enteral or parenteral) with non-curative intent
5. Has been receiving treatment for at least 2 months
6. Life expectancy of at least 6 months, in the opinion of the treating oncologist
7. Cognitively able to give informed consent

Exclusion criteria

1. Under the age of 21
2. Does not understand English or Spanish
3. Has cognitive deficits that would preclude understanding of consent form and/or questionnaires
4. Undergoing treatment with curative intent (e.g., adjuvant chemotherapy for breast, lung, or ovarian cancer, primary curative therapy for testis cancer or lymphoma)
5. Not undergoing systemic therapy (enteral or parenteral) with non-curative intent
6. Receiving treatment for fewer than 2 months
7. Life expectancy is less than 6 months, in the opinion of the treating oncologist

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,000 participants in 2 patient groups

Intervention

Experimental group

Description:

Participants randomized to the intervention arm will complete their monthly screening using the single-item screening question (every 4 weeks for 12 months).

Treatment:

Other: Financial Hardship Screening

Enhanced Usual Care

Active Comparator group

Description:

Participants randomized to receive enhanced usual care will not be systematically screened for financial hardship through the electronic PRO Core system.

Treatment:

Other: Enhanced Usual Care