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

尽管最近在晚期黑色素瘤的免疫治疗和分子靶向治疗方面取得了进展，但早期发现仍然是预防黑色素瘤死亡的最有效手段。目前，医生没有统一的方法来有效地教导379万有患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，告知他们的第一级亲属他们患黑色素瘤的风险，以及如何让他们的亲属通过进行皮肤自我检查来管理他们的风险，以提高黑色素瘤的早期发现和他们从这种致命疾病中存活下来。当前卫生保健系统的弱点导致黑色素瘤患者亲属的过度焦虑，不必要地去皮肤科医生那里进行不必要的皮肤活检，并增加了卫生保健系统的成本。通过一项随机对照试验，我们将验证Eviderma的使用，它扩展了Vignet移动Telederm系统的医生到医生的咨询，为黑色素瘤患者及其一级亲属提供有关其患黑色素瘤的风险和早期发现的重要性的教育，教授执行SSE的技能，提供家庭使用的日记，并提供皮肤科医生的访问。黑色素瘤患者及其亲属将下载Eviderma，并通过学习如何执行SSE来自我报告他们对护理计划的遵守情况，报告他们的SSE结果，并向皮肤科医生发送色素病变（痣）的照片，皮肤科医生将建议下一步的步骤。

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.