Dataset Information

Implementing an Internet-Delivered Skin Cancer Genetic Testing Intervention to Improve Sun Protection Behavior in a Diverse Population: Protocol for a Randomized Controlled Trial.

ABSTRACT: BACKGROUND:Limited translational genomic research currently exists to guide the availability, comprehension, and appropriate use of personalized genomics in diverse general population subgroups. Melanoma skin cancers are preventable, curable, common in the general population, and disproportionately increasing in Hispanics. OBJECTIVE:Variants in the melanocortin-1 receptor (MC1R) gene are present in approximately 50% of the population, are major factors in determining sun sensitivity, and confer a 2-to-3-fold increase in melanoma risk in the general population, even in populations with darker skin. Therefore, feedback regarding MC1R risk status may raise risk awareness and protective behavior in the general population. METHODS:We are conducting a randomized controlled trial examining Internet presentation of the risks and benefits of personalized genomic testing for MC1R gene variants that are associated with increased melanoma risk. We will enroll a total of 885 participants (462 participants are currently enrolled), who will be randomized 6:1 to personalized genomic testing for melanoma risk versus waiting list control. Control participants will be offered testing after outcome assessments. Participants will be balanced across self-reported Hispanic versus non-Hispanic ethnicity (n=750 in personalized genomic testing for melanoma risk arm; n=135 in control arm), and will be recruited from a general population cohort in Albuquerque, New Mexico, which is subject to year-round sun exposure. Baseline surveys will be completed in-person with study staff and follow-up measures will be completed via telephone. RESULTS:Aim 1 of the trial will examine the personal utility of personalized genomic testing for melanoma risk in terms of short-term (3-month) sun protection and skin screening behaviors, family and physician communication, and melanoma threat and control beliefs (ie, putative mediators of behavior change). We will also examine potential unintended consequences of testing among those who receive average-risk personalized genomic testing for melanoma risk findings, and examine predictors of sun protection at 3 months as the outcome. These findings will be used to develop messages for groups that receive average-risk feedback. Aim 2 will compare rates of test consideration in Hispanics versus non-Hispanics, including consideration of testing pros and cons and registration of a decision to either accept or decline testing. Aim 3 will examine personalized genomic testing for melanoma risk feedback comprehension, recall, satisfaction, and cancer-related distress in those who undergo testing, and whether these outcomes differ by ethnicity (Hispanic vs non-Hispanic), or sociocultural or demographic factors. Final outcome data collection is anticipated to be complete by October 2017, at which point data analysis will commence. CONCLUSIONS:This study has important implications for personalized genomics in the context of melanoma risk, and may be broadly applicable as a model for delivery of personalized genomic feedback for other health conditions.

SUBMITTER: Hay JL

PROVIDER: S-EPMC5424125 | biostudies-literature | 2017 Apr

REPOSITORIES: biostudies-literature

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Implementing an Internet-Delivered Skin Cancer Genetic Testing Intervention to Improve Sun Protection Behavior in a Diverse Population: Protocol for a Randomized Controlled Trial.

Hay Jennifer L JL Berwick Marianne M Zielaskowski Kate K White Kirsten Am KA Rodríguez Vivian M VM Robers Erika E Guest Dolores D DD Sussman Andrew A Talamantes Yvonne Y Schwartz Matthew R MR Greb Jennie J Bigney Jessica J Kaphingst Kimberly A KA Hunley Keith K Buller David B DB

JMIR research protocols 20170425 4

<h4>Background</h4>Limited translational genomic research currently exists to guide the availability, comprehension, and appropriate use of personalized genomics in diverse general population subgroups. Melanoma skin cancers are preventable, curable, common in the general population, and disproportionately increasing in Hispanics.<h4>Objective</h4>Variants in the melanocortin-1 receptor (MC1R) gene are present in approximately 50% of the population, are major factors in determining sun sensitivi ...[more]

PMID: 28442450

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Project description:In contrast to other areas of medical practice, there was a lack of a clear, concise and accessible synthesis of scientific literature to aid the recognition and investigation of suspected child abuse, and no national training program or evidence based guidelines for clinicians. The project's aim was to identify the current scientific evidence for the recognition and investigation of suspected child abuse and neglect and to disseminate and introduce this into clinical practice. Since 2003 a comprehensive program of Systematic Reviews of all aspects of physical abuse, emotional abuse, and neglect of children, has been developed. Based on NHS Centre for Reviews and Dissemination standards, methodology was devised and reviewers trained. Dissemination was via peer reviewed publications, a series of leaflets highlighting key points in a Question and Answer format, and a website. To date, 21 systematic reviews have been completed, generating 28 peer reviewed publications, and six leaflets around each theme (eg fractures, bruising). More than 250,000 have been distributed to date. Our website generates more than 10,000 hits monthly. It hosts primary reviews that are updated annually, links to all included studies, publications, and detailed methodology. The reviews have directly informed five national clinical guidelines, and the first evidence based training in Child Maltreatment. Child abuse is every health practitioner's responsibility, and it is vital that the decisions made are evidence based, as it is expected in all other fields of medicine. Although challenging, this project demonstrates that it is possible to conduct high quality systematic reviews in this field. For the first time a clear concise synthesis of up to date scientific evidence is available to all practitioners in a range of accessible formats. This has underpinned high quality national guidance and training programs. It ensures all professionals have the appropriate knowledge base in this difficult and challenging field.

Project description:ImportanceAtopic dermatitis is a common and debilitating skin condition characterized by intense itching and chronic inflammation. Research on behavioral treatments with high accessibility is needed.ObjectiveTo investigate the efficacy of a highly scalable internet-delivered cognitive behavior therapy (CBT) for adults with atopic dermatitis.Design, setting, and participantsThis randomized clinical trial from a medical university in Stockholm, Sweden, included 102 adults with atopic dermatitis, recruited from across Sweden, who received 12 weeks of internet-delivered CBT (March 29, 2017, to February 16, 2018). The first participant provided screening data on November 27, 2016, and the last 1-year follow-up assessment was conducted on June 28, 2019.InterventionsParticipants were randomized in a 1:1 ratio to 12 weeks of therapist-guided internet-delivered CBT (n = 51) or a control condition (n = 51) that gave instructions about standard care.Main outcomes and measuresThe primary outcome was the between-group difference in mean reduction of atopic dermatitis symptoms as measured by the Patient-Oriented Eczema Measure and modeled intention to treat during the 12-week treatment period.ResultsA total of 102 participants (mean [SD] age, 37 [11] years; 83 [81%] female) were recruited and randomized. The primary analysis indicated that participants receiving internet-delivered CBT, relative to the controls, had a significantly larger mean weekly reduction in symptoms of atopic dermatitis as measured with the Patient-Oriented Eczema Measure (B = 0.32; 95% CI, 0.14-0.49; P < .001), with a moderate to large, controlled effect size after treatment (d = 0.75; 95% CI, 0.32-1.16). Secondary analyses indicated that internet-delivered CBT also produced significantly larger reductions in itch intensity, perceived stress, sleep problems, and depression. Gains were sustained at 12 months of follow-up. Treatment satisfaction was high, and therapists spent a mean (SD) of 39.7 (34.7) minutes per treated patient providing internet-delivered CBT.Conclusions and relevanceInternet-delivered CBT appears to be efficacious for reducing symptoms of atopic dermatitis, despite requiring minimal therapist resources. Thus, internet-delivered CBT has the potential to increase access to effective adjunct behavioral treatment for patients with this common skin condition.Trial registrationClinicalTrials.gov Identifier: NCT03051958.

Dataset Information

Implementing an Internet-Delivered Skin Cancer Genetic Testing Intervention to Improve Sun Protection Behavior in a Diverse Population: Protocol for a Randomized Controlled Trial.

Publications

Implementing an Internet-Delivered Skin Cancer Genetic Testing Intervention to Improve Sun Protection Behavior in a Diverse Population: Protocol for a Randomized Controlled Trial.

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