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Studying Off Label Insurance Coverage for Patients With Cutaneous Cancers a "Filter" Observational Study

ConditionsClinical Stage II Cutaneous Merkel Cell Carcinoma AJCC v8Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8Clinical Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8Locally Advanced Basal Cell CarcinomaLocally Advanced Malignant Skin NeoplasmLocally Advanced Merkel Cell CarcinomaLocally Advanced Mucosal MelanomaLocally Advanced Squamous Cell Carcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOhio State University Comprehensive Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

* MERKEL CELL CARCINOMA

Signed informed consent

Pathology report confirming Merkel at the time of screening

Stage II, III or IV resectable (criteria based on Merkel Cell carcinoma TNM pathologic staging AJCC UICC 8th edition) or unresectable cancers amenable to surgery if a response is elicited with neoadjuvant therapy

Disqualifiers

* MERKEL CELL CARCINOMA

Metastatic disease not amenable to complete resection

Prior immunotherapy, chemotherapy, or radiation therapy for treatment of MCC within the past year

Any clinically significant medical condition, which in the judgment of the attending physician would contraindicate immunotherapy

Trial population

Participants with Merkel cell carcinoma, mucosal melanoma, basal cell carcinoma, and miscellaneous rare cutaneous cancers will be recruited from The James Comprehensive Cancer Center during the course of usual care.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Non-Interventional Study

    Other intervention

    Non-interventional study

Treatment groups

70 Participants
are divided into 4 treatment groups
Group A: Cohort 1: Merkel cell carcinoma1 intervention
Group B: Cohort 2: Mucosal melanoma1 intervention
Group C: Cohort 3: Basal cell carcinoma1 intervention
Group D: Cohort 4: Rare cutaneous cancers1 intervention

Trial outcomes

Primary outcomes

1

Time 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
2

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
3

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
4

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ohio State University Comprehensive Cancer Center

Lead sponsor

Source ClinicalTrials.gov
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