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      A randomized trial of a wearable UV dosimeter for skin cancer prevention

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          Abstract

          Background

          Non-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.

          Methods

          In 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.

          Results

          Over 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.

          Conclusion

          This 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.

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          Most cited references30

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          The cancer genome.

          All cancers arise as a result of changes that have occurred in the DNA sequence of the genomes of cancer cells. Over the past quarter of a century much has been learnt about these mutations and the abnormal genes that operate in human cancers. We are now, however, moving into an era in which it will be possible to obtain the complete DNA sequence of large numbers of cancer genomes. These studies will provide us with a detailed and comprehensive perspective on how individual cancers have developed.
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            Incidence Estimate of Nonmelanoma Skin Cancer (Keratinocyte Carcinomas) in the U.S. Population, 2012.

            Understanding skin cancer incidence is critical for planning prevention and treatment strategies and allocating medical resources. However, owing to lack of national reporting and previously nonspecific diagnosis classification, accurate measurement of the US incidence of nonmelanoma skin cancer (NMSC) has been difficult.
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              The Hawthorne Effect: a randomised, controlled trial

              Background The 'Hawthorne Effect' may be an important factor affecting the generalisability of clinical research to routine practice, but has been little studied. Hawthorne Effects have been reported in previous clinical trials in dementia but to our knowledge, no attempt has been made to quantify them. Our aim was to compare minimal follow-up to intensive follow-up in participants in a placebo controlled trial of Ginkgo biloba for treating mild-moderate dementia. Methods Participants in a dementia trial were randomised to intensive follow-up (with comprehensive assessment visits at baseline and two, four and six months post randomisation) or minimal follow-up (with an abbreviated assessment at baseline and a full assessment at six months). Our primary outcomes were cognitive functioning (ADAS-Cog) and participant and carer-rated quality of life (QOL-AD). Results We recruited 176 participants, mainly through general practices. The main analysis was based on Intention to treat (ITT), with available data. In the ANCOVA model with baseline score as a co-variate, follow-up group had a significant effect on outcome at six months on the ADAS-Cog score (n = 140; mean difference = -2.018; 95%CI -3.914, -0.121; p = 0.037 favouring the intensive follow-up group), and on participant-rated quality of life score (n = 142; mean difference = -1.382; 95%CI -2.642, -0.122; p = 0.032 favouring minimal follow-up group). There was no significant difference on carer quality of life. Conclusion We found that more intensive follow-up of individuals in a placebo-controlled clinical trial of Ginkgo biloba for treating mild-moderate dementia resulted in a better outcome than minimal follow-up, as measured by their cognitive functioning. Trial registration Current controlled trials: ISRCTN45577048
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                Author and article information

                Contributors
                URI : https://loop.frontiersin.org/people/2378159/overviewRole: Role: Role: Role: Role: Role: Role: Role: Role: Role: Role: Role:
                URI : https://loop.frontiersin.org/people/2560784/overviewRole: Role: Role: Role: Role: Role: Role: Role: Role: Role: Role: Role: Role:
                Role: Role: Role: Role: Role:
                Role: Role:
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                URI : https://loop.frontiersin.org/people/1610273/overviewRole: Role: Role: Role:
                URI : https://loop.frontiersin.org/people/1584725/overviewRole: Role: Role: Role: Role: Role: Role: Role: Role:
                URI : https://loop.frontiersin.org/people/2619300/overviewRole: Role: Role: Role: Role: Role:
                Journal
                Front Med (Lausanne)
                Front Med (Lausanne)
                Front. Med.
                Frontiers in Medicine
                Frontiers Media S.A.
                2296-858X
                01 March 2024
                2024
                : 11
                : 1259050
                Affiliations
                [1] 1Shade , Nutley, NJ, United States
                [2] 2Hackensack Meridian Center for Discovery and Innovation , Nutley, NJ, United States
                [3] 3Department of Pathology, New York University Langone Health , New York, NY, United States
                [4] 4Department of Dermatology, Weill Cornell Medicine , New York, NY, United States
                [5] 5Department of Dermatology, University Hospital Henri Mondor , Créteil, France
                Author notes

                Edited by: Lawrence Chukwudi Nwabudike, National Institute for Diabetes, Nutrition and Metabolic Diseases N. Paulescu, Romania

                Reviewed by: Erere Otrofanowei, University of Lagos, Nigeria

                Marc Wittlich, Institut für Arbeitsschutz der Deutschen Gesetzlichen Unfallversicherung (IFA), Germany

                *Correspondence: Emmanuel L. P. Dumont, em@ 123456shade.io
                Article
                10.3389/fmed.2024.1259050
                10940533
                38495115
                15e1b6b4-7e44-4647-8ead-fe8cd9acd4da
                Copyright © 2024 Dumont, Kaplan, Do, Banerjee, Barrer, Ezzedine, Zippin and Varghese.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

                History
                : 15 July 2023
                : 20 February 2024
                Page count
                Figures: 4, Tables: 1, Equations: 0, References: 33, Pages: 9, Words: 6079
                Funding
                The author(s) declare financial support was received for the research, authorship, and/or publication of this article. This work was funded by the National Cancer Institute (contract HHSN261201700005C).
                Categories
                Medicine
                Clinical Trial
                Custom metadata
                Dermatology

                skin cancer,basal cell carcinoma,squamous cell carcinoma,photoprotection,ultraviolet exposure

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