SBIR TOPIC 342 - Direct to Phase II: Melanoma Early Detection RCT With Smartphones, Cognitive Computing & Family Social Support

尽管晚期黑色素瘤的免疫治疗和分子靶向治疗最近取得了进展，但早期发现仍然是预防黑色素瘤死亡的最有效手段。目前，医生们没有统一的方法来有效地教育379万有黑色素瘤风险的人如何检查他们的皮肤是否有黑色素瘤。没有向黑色素瘤患者提供沟通材料，以告知他们的一级亲属他们患黑色素瘤的风险，以及如何通过进行皮肤自我检查来让他们的亲属参与管理他们的风险，以提高黑色素瘤的早期发现和这种致命疾病的存活率。当前医疗保健系统的弱点导致黑色素瘤患者亲属过度焦虑，不必要的皮肤科医生进行不必要的皮肤活检，并增加了医疗保健系统的成本。通过随机对照试验，我们将验证扩展Vignet Mobile Telederm系统经过验证的医生对医生咨询的Eviderma的使用，为黑色素瘤患者及其一级亲属提供关于他们患黑色素瘤的风险和早期发现的重要性的教育，教授进行SSE的技能，提供家庭使用的日记和接触皮肤科医生的机会。黑色素瘤患者和亲属将下载Eviderma，并通过学习如何执行SSE来自我报告他们遵守护理计划的情况，报告他们的SSE结果，并向皮肤科医生发送一张色素损害(葡萄胎)的图片，皮肤科医生将建议下一步步骤。 我们假设，使用伊维德玛的黑色素瘤患者和一级亲属将a)提高他们对发生黑色素瘤的风险、早期检测的重要性和SSE表现的认识，b)学习有效和高效地聘请皮肤科医生对相关皮损进行皮肤检查，以及c)将其传播给朋友和亲戚。我们将进行随机临床试验，以开发和严格测试伊维德病。此外，我们将评估直接成本，如筛查医生、相关葡萄胎的活检和病理解释，以及当早期发现失败时晚期黑色素瘤的预计护理成本。还将评估患者的间接成本，包括旅行、工作损失和家庭损失。一项成功试验的影响应该是填补目前黑色素瘤患者及其一级亲属护理的空白，降低医疗成本，提高患者对SSE表现的依从性，发现处于可治愈阶段的黑色素瘤，并降低死亡率。

Despite recent advances in immunotherapy and molecularly targeted therapies for advanced melanoma, early detection remains the most effective means of preventing death from melanoma. Currently, physicians have no uniform way to efficiently and effectively teach the 3.79 million people at-risk to develop melanoma how to check their skin for melanoma. Melanoma patients are not provided with communication materials to inform their first degree relatives of their risk of developing melanoma and how to engage their relatives in managing their risk by performing skin self-examination to improve early detection of melanoma and their survival from this deadly disease. The weakness in the current health care system result in undue anxiety among relatives of melanoma patients, unnecessary visits to the dermatologist with unnecessary skin biopsies, and increased cost to the health care system. Through a RCT, we will validate the use of Eviderma that extends the proven physician-to physician consultation of the Vignet Mobile Telederm system to provide melanoma patients and their first-degree relatives education about their risk of developing melanoma and the importance of early detection, teach the skills to perform SSE, provide diaries for home use and access to dermatologists. The melanoma patient and relative will download the Eviderma and self report their adherence to their care plan by learning how to perform SSE, report their SSE results, and send the dermatologist a picture of a pigmented lesion (mole), and the dermatologist will recommend next steps. We hypothesize that melanoma patients and first-degree relatives, who use Eviderma, will a) improve their awareness of being at-risk of developing melanoma, importance of early detection, and SSE performance, b) learn to engage dermatologists effectively and efficiently for skin examination of concerning lesions, and c) disseminate it to friends and relatives. We will conduct a randomized clinical trial in order to develop and rigorously test Eviderma. In addition, we will assess the direct costs such as physician visits for screening, biopsy of concerning moles and the pathologic interpretation as well as the projected cost of care of advanced melanoma when early detection failed. Indirect costs for the patient, including travel, time lost from work and family will also be assessed. The impact of a successful trial should be to fill the current gap in the care of melanoma patients and their first-degree relatives, reduce health care costs, improve patient adherence to SSE performance, detect melanoma in the curable stage, and reduce mortality.