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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Financial Hardship Screening
  Financial Hardship Screening and Financial Needs Assessment
• Другое Enhanced Usual Care
  Enhanced Usual Care

Первичные конечные точки

• Financial Worry [Срок оценки: 6 months]

Вторичные конечные точки (3)

• Health-related quality of life [Срок оценки: 6 months]
• Symptom burden [Срок оценки: 6 months]
• Cancer treatment adherence [Срок оценки: 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 6 центров

• 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

Пуэрто-Рико · 1 центр

• Pan American Center for Oncology Trials — San Juan

Идентификаторы

NCT: NCT06963723 · A232403

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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