Skin Health Online for Melanoma: Better Risk Assessment

Melanoma (Skin) Clinical Trial

— SOMBRA  

Official title:

Personalized Genomic Testing for Skin Cancer - Maximizing Utility and Reach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03130569
• Other study ID #: 15-050
• Status: Completed
• Phase: N/A
• First received: April 19, 2017
• Last updated: October 5, 2017
• Start date: August 26, 2015
• Est. completion date: August 31, 2017

Study information

• Verified date: October 2017
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will have two phases, with an added usability test after Phase I and before Phase 2. Phase 1: Cognitive Interviews of materials in Spanish. Phase 2: Personalized Genomic Testing for Skin Cancer (PGT-SC). The overarching goal of this study is to learn more about how to maximize the availability, comprehension and appropriate uptake of personalized genomics among different populations in New Mexico. Primary Care patients will be recruited in their primary health clinic to complete surveys about their understanding and beliefs of skin cancer and behaviors that might help prevent skin cancer. 6 out of every 7 patients will then be asked to go to a website to learn more about skin cancer risk. Once participants have completed the education modules on this site, participants will be given the option to request and complete a skin cancer genetic testing kit. All participants will be contacted again after three months to complete a follow-up set of surveys about skin cancer.

Description:

This study will have two phases, with an added usability test after Phase I and before Phase

2. Phase 1: Cognitive Interviews in Spanish. Phase 2: Personalized Genomic Testing for Skin Cancer (PGT-SC).

The overarching goal of this study is to learn more about how to maximize the availability, comprehension and appropriate uptake of personalized genomics among different populations in New Mexico. The study has been funded as an R01 by NCI for three years.

Aim I: To examine the personal utility (that is, how does personal genomic testing help the individual) of Personal Genomic Testing for Skin Cancer (PGT-SC) in terms of short-term (three months after testing) sun protection, skin screening (i.e., behaviors), communication, melanoma threat and control beliefs (i.e., putative mediators of behavior change). Guided by Protection Motivation Theory, the investigators hypothesize that behaviors and putative mediators will be higher in those who test, compared to those who decline testing or wait-list controls.

Aim Ia. An important challenge of personal genomics involves the potential for those who receive "negative" genetic feedback to increase risky behaviors. To examine this potential unintended consequence of testing, the investigators will conduct a subgroup analysis among those who receive average risk PGT-SC findings, examining sun protection at three months as the outcome. Predictors will include baseline skin cancer threat and control beliefs, skin cancer risk factors, and demographics. These findings will be used in future studies to develop messages for groups that receive average risk feedback, which accounts for large segments of those tested for moderate risk susceptibility factors across many diseases.

Aim II: To examine differential reach of PGT-SC across Hispanics and Non-Hispanics, and potential explanations for any differential reach. Reach is defined as the extent to which genomic testing is spread throughout the population. Reach will be measured in individuals as the consideration of the pros and cons of testing and registration of test decision. Additional assessments of reach include baseline survey completion and decision to pursue PGT-SC testing. The investigators hypothesize that those who are self-identified Hispanic will show reduced reach, but that differences in health literacy, health system distrust, and Hispanic sociocultural factors including cancer fatalism, family health orientation, and skin cancer misperceptions will explain differences in reach between Hispanics and Non-Hispanics, and provide guidance for future PGT-SC modifications for Hispanics.

Aim III: Among those who undergo testing, to examine (two weeks after PGT-SC test result receipt) test comprehension, recall, satisfaction, and cancer-related distress, and whether these outcomes differ by ethnicity (Hispanic versus Non-Hispanic) or health literacy, distrust, sociocultural, or demographic factors. The investigators hypothesize, based on prior work delivering this intervention in primary care, the results will reflect high test comprehension, accurate feedback interpretation, and low test distress in those who get tested.

Background. Personalized genomics currently has extremely limited reach. First, most gene discovery has not engaged diverse research cohorts. Second, the few translational research efforts that address "real world" genomic challenges and opportunities have engaged those with higher socioeconomic status and health literacy. Third, ethnic and racial minorities are less likely to participate in basic genomics research, and are also less likely to utilize available genomic technologies, even when they are offered. Ideally, the investigators should all have fair access to the knowledge gained from sequencing the human genome, but if these trends continue, the investigators will know little about how to maximize availability, comprehension, and appropriate uptake of personalized genomics across large subpopulations that stand to benefit from it.

To begin to address this, The Multiplex Study led by the National Human Genome Research Institute (NHGRI) used population-based recruitment strategies in Detroit, Michigan to evaluate an Internet-provided offer of genomic testing for common diseases, including melanoma, the most serious form of skin cancer. Study findings indicate that this approach is feasible - resulting in high test comprehension, accurate feedback interpretation, and low test distress in those who sought testing. Yet this study did not include Hispanics nor assess behavioral outcomes.

Personalized genomic testing for skin cancer (PGT-SC) is an ideal context to extend Multiplex to a new population, and new outcomes. Skin cancers are preventable, curable, very common in the general population, and disproportionately increasing in Hispanics. The NHGRI Multiplex Study offered testing for melanoma risk via the melanocortin 1 receptor gene (MC1R) because MC1R is common in the general population (50% >1 high risk variant), interacts with sun exposure, and confers risk (2-3 fold; consistent with most moderate risk variants), even in those with darker skin types. MC1R feedback is a promising vehicle to raise risk awareness and protective behavior in the general population, including Hispanics who are largely unaware of their melanoma risks. The investigators will conduct a randomized controlled trial examining internet presentation of the risks and benefits of PGT-SC (shown to be feasible in Multiplex) versus wait-list controls who are not offered testing, comparing personal utility and reach in a general population, English or Spanish-speaking cohort in Albuquerque, New Mexico, where there is year-round sun exposure.

Prior investigator collaborations. This transdisciplinary effort will bring together the combined expertise of investigators - many of whom have productive, longstanding collaborations already - to integrate up-to-date research findings from their respective disciplines, a necessary step given that the rapid unfolding of new cancer genomic, communication, and behavioral science findings is the expected reality of these fields. The investigators employ a Multiple PI Plan. Dr. Jennifer Hay, Principal Investigator is an expert in risk communication and behavior change who has worked with Dr. Marianne Berwick, Principal Investigator, a genetic epidemiologist and a leader in the field of the genetic factors in melanoma for over 10 years. Drs. Hay and Berwick conducted studies examining family communication and health behavior change (screening, sun protection) in melanoma families, and found a high rate of discussion about melanoma risk in melanoma families, that different patterns of family communication after melanoma diagnosis influence adoption of prevention strategies, inconsistent adoption of such strategies in survivors, and that behavioral outcomes associated with hypothetical melanoma genetic testing differ based on positive versus negative risk feedback.

Pilot research conducted by the investigators at the University of New Mexico (UNM) indicate that primary care patients are receptive to skin cancer genomic communication; UNM Hispanics report higher skin cancer misconceptions. Drs. Hay and Berwick conducted this pilot study in the UNM 1209 Clinic to examine 1) patients' receptivity to behavioral research studies in skin cancer and genetics, 2) to document levels of sunscreen and protective clothing use, shade-seeking, and health provider skin cancer screening examinations, 3) to examine prior health information-seeking and family cancer discussions, and 4) prevalence of accurate skin cancer beliefs. Most (71%) participants were female and they ranged in age from 19-81 years (n=50), with racial/ethnic subgroups consistent with the Albuquerque population (46% were Hispanic, 35% were Non-Hispanic White, 6% Native American, 3% African American, and 10% other). Nine percent had not completed high school, and 55% had household incomes less than $30k/year. About one third (30%) reported a family skin cancer history and 7% a personal skin cancer history. About two-thirds (66%) reported interest in behavioral skin cancer research, and while few (17%) had heard of genetic testing marketed directly to consumers, two thirds (76%) said they would be interested in learning more about genetic testing for skin cancer. Sun protection and skin cancer screening levels were consistent with recent national data; 29% reported that they consistently used sunscreen, 62% wore a shirt with sleeves, 34% a hat, and 47% sought shade often or always while outside on a sunny day. Even fewer (26%) had ever received a health provider skin examination. Non-Hispanic Whites reported more consistent use of sunscreen, and were more likely to have received a prior health provider skin examination than Hispanics and other racial/ethnic groups (all p values <0.01). Two-thirds (62%) reported that they were moderately or highly likely to develop skin cancer. Predominant reasons for heightened risk included current or past sun exposure, fair skin, and family history or genetic factors. Spontaneous health information-seeking was common, with 72% reporting that they had ever sought information on medical topics, predominantly via the internet. Over half (62%) had sought cancer information. About half (55%) had talked about cancer risk, and 37% about skin cancer risk, in their family. Those with higher perceived skin cancer risk talked more about it with their family (r=0.34, p=0.001) and were more interested in skin cancer behavioral research participation (r=0.26, p=0.01). The investigators assess skin cancer misconceptions as an explanation for reduced PGT-SC reach in Aim II of the current study, because Hispanics reported more skin cancer misconceptions than Non-Hispanic Whites in the investigators' UNM pilot study. Over half of Hispanics endorsed confusion about which skin cancer recommendations to follow, and significant proportions of Hispanics agreed with the statement "it seems likely almost everything causes skin cancer" (24%); and "people with skin cancer would have pain or other symptoms prior to diagnosis" (24%). Also in the investigators' prior work with nationally representative samples, the investigators found that Non-Hispanic Whites had higher awareness of accurate skin cancer causes, prevention strategies, and symptoms than Hispanics. Hispanics reported higher levels of information overload and misconceptions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 628
• Est. completion date: August 31, 2017
• Est. primary completion date: August 18, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Registered at a University of New Mexico primary care clinic for =6 months

• Assigned to a primary care provider

• Fluent in either English or Spanish

Exclusion Criteria:

• Unable to consent

• <18 years old

• Prisoner

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

Behavioral:
• Web-based Module Group

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico

Sponsors (2)

Lead Sponsor	Collaborator
University of New Mexico	Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

References & Publications (26)

Bloss CS, Ornowski L, Silver E, Cargill M, Vanier V, Schork NJ, Topol EJ. Consumer perceptions of direct-to-consumer personalized genomic risk assessments. Genet Med. 2010 Sep;12(9):556-66. doi: 10.1097/GIM.0b013e3181eb51c6. — View Citation

Demenais F, Mohamdi H, Chaudru V, Goldstein AM, Newton Bishop JA, Bishop DT, Kanetsky PA, Hayward NK, Gillanders E, Elder DE, Avril MF, Azizi E, van Belle P, Bergman W, Bianchi-Scarrà G, Bressac-de Paillerets B, Calista D, Carrera C, Hansson J, Harland M, Hogg D, Höiom V, Holland EA, Ingvar C, Landi MT, Lang JM, Mackie RM, Mann GJ, Ming ME, Njauw CJ, Olsson H, Palmer J, Pastorino L, Puig S, Randerson-Moor J, Stark M, Tsao H, Tucker MA, van der Velden P, Yang XR, Gruis N; Melanoma Genetics Consortium. Association of MC1R variants and host phenotypes with melanoma risk in CDKN2A mutation carriers: a GenoMEL study. J Natl Cancer Inst. 2010 Oct 20;102(20):1568-83. doi: 10.1093/jnci/djq363. Epub 2010 Sep 28. — View Citation

Friedman LC, Bruce S, Weinberg AD, Cooper HP, Yen AH, Hill M. Early detection of skin cancer: racial/ethnic differences in behaviors and attitudes. J Cancer Educ. 1994 Summer;9(2):105-10. — View Citation

Green ED, Guyer MS; National Human Genome Research Institute. Charting a course for genomic medicine from base pairs to bedside. Nature. 2011 Feb 10;470(7333):204-13. doi: 10.1038/nature09764. — View Citation

Hay J, Coups EJ, Ford J, DiBonaventura M. Exposure to mass media health information, skin cancer beliefs, and sun protection behaviors in a United States probability sample. J Am Acad Dermatol. 2009 Nov;61(5):783-92. doi: 10.1016/j.jaad.2009.04.023. Epub 2009 Jul 10. — View Citation

Hay J, Kaphingst KA, Baser R, Li Y, Hensley-Alford S, McBride CM. Skin cancer concerns and genetic risk information-seeking in primary care. Public Health Genomics. 2012;15(2):57-72. doi: 10.1159/000330403. Epub 2011 Sep 13. — View Citation

Hay J, Ostroff J, Martin A, Serle N, Soma S, Mujumdar U, Berwick M. Skin cancer risk discussions in melanoma-affected families. J Cancer Educ. 2005 Winter;20(4):240-6. — View Citation

Hay J, Shuk E, Brady MS, Berwick M, Ostroff J, Halpern A. Family communication after melanoma diagnosis. Arch Dermatol. 2008 Apr;144(4):553-4. doi: 10.1001/archderm.144.4.553. — View Citation

Hay J, Shuk E, Zapolska J, et al. Family communication patterns after melanoma diagnosis. Journal of Family Communication. 2009;9(4):209-232.

Hay JL, Baguer C, Li Y, Orlow I, Berwick M. Interpretation of melanoma risk feedback in first-degree relatives of melanoma patients. J Cancer Epidemiol. 2012;2012:374842. doi: 10.1155/2012/374842. Epub 2012 Jul 25. — View Citation

Hindorff LA, Sethupathy P, Junkins HA, Ramos EM, Mehta JP, Collins FS, Manolio TA. Potential etiologic and functional implications of genome-wide association loci for human diseases and traits. Proc Natl Acad Sci U S A. 2009 Jun 9;106(23):9362-7. doi: 10.1073/pnas.0903103106. Epub 2009 May 27. — View Citation

Hu S, Parmet Y, Allen G, Parker DF, Ma F, Rouhani P, Kirsner RS. Disparity in melanoma: a trend analysis of melanoma incidence and stage at diagnosis among whites, Hispanics, and blacks in Florida. Arch Dermatol. 2009 Dec;145(12):1369-74. doi: 10.1001/archdermatol.2009.302. — View Citation

James RD, Yu JH, Henrikson NB, Bowen DJ, Fullerton SM; Health Disparities Working Group. Strategies and stakeholders: minority recruitment in cancer genetics research. Community Genet. 2008;11(4):241-9. doi: 10.1159/000116878. Epub 2008 Apr 14. Review. — View Citation

Kaphingst KA, McBride CM, Wade C, Alford SH, Reid R, Larson E, Baxevanis AD, Brody LC. Patients' understanding of and responses to multiplex genetic susceptibility test results. Genet Med. 2012 Jul;14(7):681-7. — View Citation

Khoury MJ, Clauser SB, Freedman AN, Gillanders EM, Glasgow RE, Klein WM, Schully SD. Population sciences, translational research, and the opportunities and challenges for genomics to reduce the burden of cancer in the 21st century. Cancer Epidemiol Biomarkers Prev. 2011 Oct;20(10):2105-14. doi: 10.1158/1055-9965.EPI-11-0481. Epub 2011 Jul 27. Review. — View Citation

Lazovich D, Choi K, Vogel RI. Time to get serious about skin cancer prevention. Cancer Epidemiol Biomarkers Prev. 2012 Nov;21(11):1893-901. doi: 10.1158/1055-9965.EPI-12-0327. Epub 2012 Sep 7. — View Citation

Mujumdar UJ, Hay JL, Monroe-Hinds YC, Hummer AJ, Begg CB, Wilcox HB, Oliveria SA, Berwick M. Sun protection and skin self-examination in melanoma survivors. Psychooncology. 2009 Oct;18(10):1106-15. doi: 10.1002/pon.1510. — View Citation

Pagán JA, Su D, Li L, Armstrong K, Asch DA. Racial and ethnic disparities in awareness of genetic testing for cancer risk. Am J Prev Med. 2009 Dec;37(6):524-30. doi: 10.1016/j.amepre.2009.07.021. — View Citation

Pipitone M, Robinson JK, Camara C, Chittineni B, Fisher SG. Skin cancer awareness in suburban employees: a Hispanic perspective. J Am Acad Dermatol. 2002 Jul;47(1):118-23. — View Citation

Raimondi S, Sera F, Gandini S, Iodice S, Caini S, Maisonneuve P, Fargnoli MC. MC1R variants, melanoma and red hair color phenotype: a meta-analysis. Int J Cancer. 2008 Jun 15;122(12):2753-60. doi: 10.1002/ijc.23396. — View Citation

Robinson JK, Joshi KM, Ortiz S, Kundu RV. Melanoma knowledge, perception, and awareness in ethnic minorities in Chicago: recommendations regarding education. Psychooncology. 2011 Mar;20(3):313-20. doi: 10.1002/pon.1736. — View Citation

Rouhani P, Pinheiro PS, Sherman R, Arheart K, Fleming LE, Mackinnon J, Kirsner RS. Increasing rates of melanoma among nonwhites in Florida compared with the United States. Arch Dermatol. 2010 Jul;146(7):741-6. doi: 10.1001/archdermatol.2010.133. — View Citation

Suther S, Kiros GE. Barriers to the use of genetic testing: a study of racial and ethnic disparities. Genet Med. 2009 Sep;11(9):655-62. doi: 10.1097/GIM.0b013e3181ab22aa. — View Citation

Torres S, Ramos M, Leverence R, Bowen D, Berwick M, Hay J. Skin Cancer Risk Reduction Behaviors, Cancer Communication, and Skin Cancer Beliefs in Hispanics in a Southwestern Primary Care Practice. Californian Journal of Health Promotion. See Appendix III for the In Press Manuscript.

Udayakumar D, Tsao H. Moderate- to low-risk variant alleles of cutaneous malignancies and nevi: lessons from genome-wide association studies. Genome Med. 2009 Oct 27;1(10):95. doi: 10.1186/gm95. — View Citation

Wade CH, McBride CM, Kardia SL, Brody LC. Considerations for designing a prototype genetic test for use in translational research. Public Health Genomics. 2010;13(3):155-65. doi: 10.1159/000236061. Epub 2009 Sep 3. — View Citation

* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Personal Utility of Personal Genomic Testing for Skin Cancer	The primary study endpoints include personal utility of Personal Genomic Testing for Skin Cancer (PGT-SC) in terms of short-term (three months after testing) sun protection, skin screening (i.e., behaviors), communication, melanoma threat and control beliefs (i.e., putative mediators of behavior change), as well as differential reach of PGT-SC across Hispanics and non-Hispanics, as well as potential explanations for any differential reach.	Three months from enrollment for each participant. Enrollment occurs on a rolling basis, to be completed August 2017.