Studying Off Label Insurance Coverage for Patients With Cutaneous Cancers a "Filter" Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Time spent obtaining approval and drugs
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •* 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
- •≥ 18 years of age
- •Genomics of the cancer attempted
- •Description of planned surgical resection by surgeon
- •Planned treatment with immunotherapy. Possible Beacon plan entitled OP NIVOLUMAB IPILIMUMAB NEUROENDOCRINE (PRL 8149)
- •2 cycles will be given prior to surgery (=12 weeks).
- •MUCOSAL MELANOMA
- •Signed informed consent
- •Pathology report confirming mucosal melanoma at the time of screening
- •Stage III or IV resectable (TNM pathologic staging AJCC UICC 8th edition) or unresectable cancers amenable to surgery if a response is elicited with neoadjuvant therapy
- •≥ 18 years of age
- •Genomics of the cancer attempted
- •Description of planned surgical resection by surgeon
- •SOC (standard of care) treatment planned with immunotherapy Possible Beacon plan entitled OP NIVOLUMAB IPILIMUMAB -> NIVOLUMAB Q4 WEEK MAINTENANCE MELANOMA 4 cycles will be given prior to surgery (=12 weeks)
- •BASAL CELL CARCINOMA
- •Signed informed consent
- •Pathology report confirming basal cell carcinoma with subtype at the time of screening
- •Resectable tumor of any stage, or unresectable tumor that could be amenable to surgery if there is a good response.
- •≥ 18 years of age
- •Genomics of the cancer attempted
- •Description of planned surgical resection by surgeon
- •SOC treatment planned with possible Beacon plan entitled OP SONIDEGIB BASAL CELL CARCINOMA 3 months will be given prior to surgery (= 12 weeks) (Vismodegib may be substituted if current national shortage of sonidegib persists)
- •RARE CUTANEOUS CANCERS
- •Signed informed consent
- •Pathology report confirming squamous cell carcinoma at the time of screening
- •Stage II, III, or IV resectable or (TNM pathologic staging AJCC UICC 8th edition) or unresectable cancers amenable to surgery if a response is elicited with neoadjuvant therapy
- •≥ 18 years of age
- •Genomics of the cancer attempted
- •Description of planned surgical resection by surgeon
- •Planned SOC treatment with possible Beacon plan entitled OP WEEKLY CARBOPLATIN PACLITAXEL + PEMBROLIZUMAB Q3 WEEKS HEAD AND NECK
- •4 cycles will be given prior to surgery (= 12 weeks)
排除标准
- •* 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
- •Is pregnant or breast feeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of SOC treatment.
- •MUCOSAL MELANOMA
- •Metastatic disease not amenable to complete resection
- •Prior immunotherapy, chemotherapy, or radiation therapy for treatment of this mucosal melanoma within the past year
- •Any clinically significant medical condition, which in the judgment of the attending physician would contraindicate immunotherapy
- •Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of SOC treatment.
- •BASAL CELL CARCINOMA
- •Metastatic disease not amenable to complete resection
- •Prior immunotherapy, chemotherapy, or radiation therapy for treatment of this basal cell carcinoma within the past year
- •Any clinically significant medical condition, which in the judgment of the attending physician would contraindicate immunotherapy
- •Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of SOC treatment.
- •RARE CUTANEOUS CANCERS
- •Metastatic disease not amenable to complete resection
- •Prior immunotherapy, chemotherapy, or radiation therapy for treatment of this mucosal melanoma within the past year
- •Any clinically significant medical condition, which in the judgment of the attending physician would contraindicate immunotherapy
- •Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of SOC treatment.
研究组 & 干预措施
Cohort 4: Rare cutaneous cancers
Patients complete a survey and have their medical records reviewed on study.
干预措施: Non-Interventional Study (Other)
Cohort 3: Basal cell carcinoma
Patients complete a survey and have their medical records reviewed on study.
干预措施: Non-Interventional Study (Other)
Cohort 1: Merkel cell carcinoma
Patients complete a survey and have their medical records reviewed on study.
干预措施: Non-Interventional Study (Other)
Cohort 2: Mucosal melanoma
Patients complete a survey and have their medical records reviewed on study.
干预措施: Non-Interventional Study (Other)
结局指标
主要结局
Time spent obtaining approval and drugs
时间窗: Up to study completion, up to 17 weeks
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.
Means of coverage
时间窗: Up to study completion, up to 17 weeks
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.
Out of pocket expenses for patients
时间窗: Up to study completion, up to 17 weeks
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.
Extent of surgical resection
时间窗: Up to study completion, up to 17 weeks
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.
次要结局
未报告次要终点
研究者
Claire Verschraegen
Principal Investigator
Ohio State University Comprehensive Cancer Center