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

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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.