Economic burden of non-approved alternative therapies among patients with stage IV cancer: A prospective observational study.

Abstract

TPS11201 Background: Complementary and alternative therapies, including herbal supplements and over-the-counter medications, are used by 9 to 81% of cancer patients post-diagnosis to alleviate symptoms, side effects, anxiety, depression, or to gain a sense of control. Prior studies suggest higher use among younger, female patients with higher socioeconomic status. However, in our institutional practice, we did not observe any specific pattern on alternative medicine use. Additionally, the financial burden (financial toxicity) of these often-out-of-pocket expenses remains understudied in advanced cancer populations. This prospective observational study aims to assess the financial toxicity and describe patterns of use of non-approved alternative therapies among patients with stage IV cancer. Methods: This is a prospective, single-center, observational study conducted at Mercy Clinic Oncology, Fort Smith, AR. Eligible patients are aged ≥18 years, diagnosed with any stage IV cancer, and currently receiving systemic therapy. Key exclusions include the inability to read/understand English, incarcerated patients, and patients only on supportive care. A convenience sample of 150 patients will be enrolled for initial analysis with plans to expand the study to a multi-institutional format. Patients meeting eligibility criteria are identified via clinic schedule review and approached in person by a research nurse. Interested patients receive a study information sheet and complete a one-time, anonymous, paper-based survey (approximately 5 minutes) either in-clinic or at home (returned at next visit). The survey includes 6 demographic/cancer/treatment questions and 6 questions on use of specific non-approved alternative therapies and estimated average monthly costs (categorized as < $25, $26–$50, $51–$100, > $100). A specific question on marijuana addresses use for cancer cure (recreational/symptom control categorized as "no"); responses are anonymous with no PHI collected to minimize risk. Analysis will use descriptive statistics (frequencies/percentages) for cost patterns (primary outcome) and therapy types (secondary outcome), with chi-squared tests for subgroup comparisons by demographics. Enrollment started beginning of January 2026, and in two weeks, nine patients were identified and approached, with seven patients completing the survey. No preliminary data are available. Clinical trial information: Not applicable (IRB-approved observational protocol 24-062).