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. 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. 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. 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. 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.

Melanoma is a common malignant neoplasm, and disproportionate increases in melanoma, particularly thicker tumors with poorer prognoses, have been documented in Hispanics in states with high levels of year-round sun exposure.^1,2 In ethnically and racially diverse populations, melanoma results in greater morbidity and mortality due to the disease often being identified at later stages, and because of low physician and patient awareness that melanomas occur in these populations.^1,3,4 Most individuals do not use sunscreen, wear protective clothing, or seek shade on a regular basis,⁵ and in the United States, approximately 35% of the population uses sunscreen consistently.⁶ This behavior extends to Hispanics of varying skin types,⁷ and Hispanics in the United States have high sunburn rates.⁸ Lower skin cancer awareness and perceived skin cancer risk have been identified as particular barriers to adequate and consistent sun protection in Hispanics.^3,9-12 Personalized genomic testing for melanoma risk may promote risk awareness and risk reduction in the general population, including Hispanics.

Harvest for Health is a home-based vegetable gardening intervention that pairs cancer survivors with Master Gardeners from the Cooperative Extension System. Initially developed and tested in Alabama, the program was adapted for the different climate, growing conditions, and population in New Mexico. This paper chronicles the feasibility, acceptability, and preliminary efficacy of “Southwest Harvest for Health”. During the nine-month single-arm trial, 30 cancer survivor-Master Gardener dyads worked together to establish and maintain three seasonal gardens. Primary outcomes were accrual, retention, and satisfaction. Secondary outcomes were vegetable and fruit (V and F) intake, physical activity, and quality of life. Recruitment was diverse and robust, with 30 survivors of various cancers, aged 50–83, roughly one-third minority, and two-thirds females enrolled in just 60 days. Despite challenges due to the COVID-19 pandemic, retention to the nine-month study was 100%, 93% reported “good-to-excellent” satisfaction, and 87% “would do it again.” A median increase of 1.2 servings of V and F/day was documented. The adapted home-based vegetable gardening program was feasible, well-received, and resulted in increased V and F consumption among adult cancer survivors. Future studies are needed to evaluate the effectiveness of this program and to inform strategies to increase the successful implementation and further dissemination of this intervention.

The objective of this study was to examine a remote method for maintaining long‐term contact with Parkinson's disease (PD) patients participating in clinical studies. Long‐term follow‐up of PD patients is needed to fill critical information gaps on progression, biomarkers, and treatment. Prospective in‐person assessment can be costly and may be impossible for some patients. Remote assessment using mail and telephone contact may be a practical follow‐up method. Patients enrolled in the multi‐center Longitudinal and Biomarker Study in Parkinson's Disease (LABS‐PD) in‐person follow‐up study in 2006 were invited to enroll in Follow‐up of Persons With Neurologic Diseases (FOUND), which is overseen by a single center under a separate, central institutional review board protocol. FOUND uses mailed questionnaires and telephone interviews to assess PD status. FOUND follow‐up continued when LABS‐PD in‐person visits ended in 2011. Retention and agreement between remote and in‐person assessments were determined. In total, 422 of 499 (84.5%) of eligible patients volunteered, AND 96% of participants were retained. Of 60 patients who withdrew consent from LABS‐PD, 51 were retained in FOUND. Of 341 patients who were active in LABS‐PD, 340 were retained in FOUND (99.7%) when the in‐person visits ceased. Exact agreement between remote and in‐person assessments was ≥ 80% for diagnosis, disease features (eg, dyskinesias), and PD medication. Correlation between expert‐rated and self‐reported Unified Parkinson's Disease Rating Scale and Movement Disorder Society Unified Parkinson's Disease Rating Scale, which were examined at times separated by several months, was moderate or substantial for most items. Retention was excellent using remote follow‐up of research participants with PD, providing a safety net when combined with in‐person visits, and also is effective as a stand‐alone assessment method, providing a useful alternative when in‐person evaluation is not feasible. © 2014 International Parkinson and Movement Disorder Society

Although national guidelines for cancer genetic risk assessment (CGRA) for hereditary breast and ovarian cancer (HBOC) have been available for over two decades, less than half of high-risk women have accessed these services, especially underserved minority and rural populations. Identification of high-risk individuals is crucial for cancer survivors and their families to benefit from biomedical advances in cancer prevention, early detection, and treatment. This paper describes community-engaged formative research and the protocol of the ongoing randomized 3-arm controlled Genetic Risk Assessment for Cancer Education and Empowerment (GRACE) trial. Ethnically and geographically diverse breast and ovarian cancer survivors at increased risk for hereditary cancer predisposition who have not had a CGRA are recruited through the three statewide cancer registries. The specific aims are to: 1) compare the effectiveness of a targeted intervention (TP) vs. a tailored counseling and navigation(TCN) intervention vs. usual care (UC) on CGRA utilization at 6 months post-diagnosis (primary outcome); compare the effectiveness of the interventions on genetic counseling uptake at 12 months after removal of cost barriers (secondary outcome); 2) examine potential underlying theoretical mediating and moderating mechanisms; and 3) conduct a cost evaluation to guide dissemination strategies. The ongoing GRACE trial addresses an important translational gap by developing and implementing evidence-based strategies to promote guideline-based care and reduce disparities in CGRA utilization among ethnically and geographically diverse women. If effective, these interventions have the potential to reach a large number of high-risk families and reduce disparities through broad dissemination. NCT03326713; clinicaltrials.gov.

Public availability of genetic information is increasing; thus, efforts to improve diversity in basic and translational research in genomics is a top priority. Given the increasing U.S. incidence and mortality of melanoma, and the prevalence of common melanocortin-1 receptor (MC1R) gene melanoma risk variants in the general population, we examined genomic testing of MC1R for skin cancer risk in a randomized controlled trial in Albuquerque, New Mexico primary care. Participants were 48% Hispanic and were randomized 5:1 to a MC1R test invitation or usual care. We assessed 3 month sun protection, skin cancer screening, and skin cancer worry outcomes associated with testing, and key effect moderators (e.g., cancer risk perceptions, and skin cancer risk factors). Our findings indicate that the primary outcomes were unchanged by the MC1R test offer, test acceptance, and level of risk feedback. Moderator analyses showed that those with lower risk perception, and those with skin that readily tans, significantly increased their sun protection in response to higher than average risk feedback. Risk feedback did not prompt cancer worry, and average risk feedback did not erode existing sun protection. This study paves the way for the development of tailored strategies to address low skin cancer risk awareness in this understudied context of public health genomics.