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

SBIR 主题 342 - 直接进入第二阶段：使用智能手机、认知计算进行黑色素瘤早期检测 RCT

• 批准号: 9531520
• 负责人: Praduman Jain
• 金额: $ 150万
• 依托单位: VIGNET, INC.
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-01-20 至 2019-01-19
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9531520
• 关键词: Adherence; Anxiety; Awareness; Biopsy; Caring; Cellular Phone; Cessation of life; Clinical assessments; Cognitive; Communication; Consultations; Contractor; Cutaneous Melanoma; Dermatologist; Direct Costs; Disease; Early Diagnosis; Education; Facilities and Administrative Costs; Family; First Degree Relative; Friends; Health Care Costs; Healthcare Systems; Home environment; Immunotherapy; Intervention; Learning; Lesion; Mole the mammal; Participant; Pathologic; Patient Self-Report; Patients; Performance; Phase; Physicians; Pigments; Randomized Clinical Trials; Randomized Controlled Trials; Reporting; Risk; Self-Examination; Skin; Small Business Innovation Research Grant; Social support; System; Testing; Travel; Validation; Visit; base; compliance behavior; cost; diaries; improved; lost work time; melanoma; mobile computing; molecular targeted therapies; mortality; neoplasm registry; prevent; screening; skills; tool

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.

尽管免疫疗法和分子靶向疗法在晚期黑色素瘤治疗方面取得了最新进展，但早期检测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授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，以告知其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，以改善黑色素瘤的早期发现和他们从这种致命疾病中的生存。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，不必要地去看皮肤科医生进行不必要的皮肤活检，并增加医疗保健系统的成本。通过随机对照试验，我们将验证Eviderma的使用，其扩展了Vignet移动的Telederm系统的经验证的医生对医生咨询，为黑色素瘤患者及其一级亲属提供关于其患黑色素瘤的风险和早期检测的重要性的教育，教授进行SSE的技能，提供家庭使用日记和皮肤科医生的访问。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性病变（痣）的图片，皮肤科医生将建议下一步。 我们假设，使用Eviderma的黑色素瘤患者和一级亲属将a）提高他们对发展黑色素瘤风险的认识，早期检测的重要性，以及SSE性能，B）学习有效和高效地聘请皮肤科医生进行皮肤检查有关病变，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Eviderma。此外，我们将评估直接成本，如医生访问的筛选，活检有关痣和病理解释，以及预计成本的护理晚期黑色素瘤时，早期检测失败。还将评估患者的间接费用，包括旅行、工作和家庭损失的时间。一项成功的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，降低医疗保健成本，提高患者对SSE性能的依从性，在可治愈阶段检测黑色素瘤，并降低死亡率。