Longitudinal Screening for Financial Hardship to Improve Outcomes in Patients With Advanced Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Financial Hardship Screening, Enhanced Usual Care.
- Who it may be relevant to
- Registry conditions: Advanced Cancer, Metastatic Cancer. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Puerto Rico
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed 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.
Interventions
- Other Financial Hardship Screening
Financial Hardship Screening and Financial Needs Assessment - Other Enhanced Usual Care
Enhanced Usual Care
Primary outcome measures
- Financial Worry [Time frame: 6 months]
Secondary outcome measures (3)
- Health-related quality of life [Time frame: 6 months]
- Symptom burden [Time frame: 6 months]
- Cancer treatment adherence [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- Minimum age of 21
- Understands English and/or Spanish
- Has a diagnosis of advanced/metastatic cancer
- Currently undergoing systemic therapy (enteral or parenteral) with non-curative intent
- Has been receiving treatment for at least 2 months
- Life expectancy of at least 6 months, in the opinion of the treating oncologist
- Cognitively able to give informed consent
Exclusion criteria
- Under the age of 21
- Does not understand English or Spanish
- Has cognitive deficits that would preclude understanding of consent form and/or questionnaires
- Undergoing treatment with curative intent (e.g., adjuvant chemotherapy for breast, lung, or ovarian cancer, primary curative therapy for testis cancer or lymphoma)
- Not undergoing systemic therapy (enteral or parenteral) with non-curative intent
- Receiving treatment for fewer than 2 months
- Life expectancy is less than 6 months, in the opinion of the treating oncologist
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 6 centers
- Dignity Health — Phoenix
- New Hampshire Oncology-Hematology, PA — Concord
- Solinsky Center for Cancer Care — Manchester
- New York City Health and Hospitals — New York
- Sanford Health — Fargo
- Gibbs Cancer Center — Spartanburg
Puerto Rico · 1 center
- Pan American Center for Oncology Trials — San Juan
Identifiers
NCT: NCT06963723 · A232403