This study evaluates the time spent on obtaining insurance approval and drugs, means of insurance coverage, out-of-pocket costs for patients, and the surgical outcomes after neoadjuvant treatment is completed in skin cancer patients receiving "off label" and "on label" neoadjuvant treatment. "Neoadjuvant therapy" means cancer treatment given before surgery. However, in many instances, neoadjuvant therapy is used as an "off-label" approach for several types of skin cancers. "Off-label" means that the FDA has not yet approved its use for that type of cancer. Therefore, insurance approval of these "off-label" treatments could be delayed compared to label use, and "off-label" treatments may require several weeks of pre-authorization. There is evidence that the delayed start of cancer treatment can lead to poorer outcomes.
PRIMARY OBJECTIVE: I. To assess in real-life clinical practice, the timing, cost, and surgical outcomes of patients who have resectable various skin cancers that are locally advanced or have a high risk of recurrence. OUTLINE: This is an observational study. Patients complete a survey and have their medical records reviewed on study.
Study Type
OBSERVATIONAL
Enrollment
70
Non-interventional study
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
RECRUITINGTime spent obtaining approval and drugs
Start and end times for obtaining approval for drugs will be based on date the initial request is submitted by the provider and the date the drugs are obtained. Confidence intervals will provide precision for estimating the mean time spent on obtaining approval and drugs and out-of-pocket expenses for patients.
Time frame: Up to study completion, up to 17 weeks
Means of coverage
Descriptive statistics will summarize the conditions of off label coverage among patients, with mean, median, interquartile range, min, and max for continuous variables and frequencies / percentages for categorical variables.
Time frame: Up to study completion, up to 17 weeks
Out of pocket expenses for patients
Descriptive statistics will summarize the conditions of off label coverage among patients, with mean, median, interquartile range, min, and max for continuous variables and frequencies / percentages for categorical variables.
Time frame: Up to study completion, up to 17 weeks
Extent of surgical resection
Planned vs empirical extent of surgical resection will be calculated and compared within each cohort, with Clopper-Pearson exact binomial 95% confidence intervals for the percent of patients receiving lesser extent of surgery.
Time frame: Up to study completion, up to 17 weeks
The Ohio State University Comprehensive Cancer Center
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