Data_Sheet_1_A randomized trial of a wearable UV dosimeter for skin cancer prevention.PDF

BackgroundNon-melanoma skin cancer (NMSC) is the most prevalent cancer in the United States. Despite guidelines on ultraviolet (UV) avoidance, it remains difficult for people to assess their exposure, as UV is invisible and the onset of UV-induced symptoms is delayed.
MethodsIn a prospective randomized trial, 97 elderly patients with a history of actinic keratoses (AK) were followed over 6 months. Fifty patients received UV counseling from a dermatologist and a wearable UV dosimeter that provided real-time and cumulative UV exposure. Forty-seven patients received only UV counseling from a dermatologist.
ResultsOver 75% of participants recorded UV exposure at least once a week during the summer. After 6 months of intervention, when comparing the device group to the control group, we observed a non-significant 20% lower ratio of incidence rates of AKs (95% CI = [−41, 55%], p-value = 0.44) and a significant 95% lower ratio of incidence rates of NMSCs (95% CI = [33, 99.6%], p-value = 0.024). Surveys demonstrated that the control group’s score in self-perceived ability to participate in social activities significantly increased by 1.2 (p-value = 0.04), while in the device group, this score non-significantly decreased by 0.9 (p-value = 0.1). We did not observe changes, or between-group differences, in anxiety and depression surveys.
ConclusionThis pilot clinical trial has a short duration and a small sample size. However, device adherence and quality of life questionnaires suggest a smartphone-connected wearable UV dosimeter is well accepted by an elderly population. This trial also indicates that a wearable UV dosimeter may be an effective behavioral change tool to reduce NMSC incidence in an elderly population with a prior history of AKs.
Clinical trial registration: clinicaltrials.gov, identifier NCT03315286.

背景：非黑色素瘤皮肤癌（Non-melanoma skin cancer, NMSC）是美国最为高发的癌症类型。尽管已有紫外线（ultraviolet, UV）防护相关指南，但由于紫外线不可见且其诱导的症状发作存在延迟，人们仍难以准确评估自身的紫外线暴露水平。
方法：本研究为一项前瞻性随机试验，共纳入97例有光化性角化病（actinic keratoses, AK）病史的老年患者，随访周期为6个月。其中50例患者接受了皮肤科医师的紫外线防护咨询，并佩戴可实时及累计监测紫外线暴露量的可穿戴式紫外线剂量计；剩余47例患者仅接受皮肤科医师的紫外线防护咨询。
结果：夏季期间，超过75%的受试者每周至少记录到一次紫外线暴露。干预6个月后，与对照组相比，设备组的光化性角化病发病率比值降低20%，但差异无统计学意义（95%置信区间CI = [-41, 55%]，P=0.44）；而非黑色素瘤皮肤癌的发病率比值显著降低95%（95%CI = [33, 99.6%]，P=0.024）。问卷调查结果显示，对照组受试者自我感知的社交活动参与能力得分显著提升1.2分（P=0.04），而设备组该得分无统计学意义的下降0.9分（P=0.1）。本研究未观察到焦虑、抑郁问卷调查结果出现组内变化或组间差异。
结论：本先导临床试验的周期较短且样本量较小。但设备依从性及生活质量问卷结果表明，可连接智能手机的可穿戴式紫外线剂量计在老年人群中具有良好的接受度。本试验同时证实，对于有光化性角化病病史的老年人群，可穿戴式紫外线剂量计或可作为有效的行为干预工具，以降低非黑色素瘤皮肤癌的发病率。
临床试验注册：clinicaltrials.gov，编号NCT03315286。