Skin Health Online for Melanoma: Better Risk Assessment

NCT03130569 | Completed Results DMC

• 1 other identifier: 15-050
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Melanoma (Skin)

Keywords

Risk Assessment; Personal Genomic Testing; Skin Cancer; Primary Care

Outcome Measures

Primary Outcomes (1)

• Reach of Personalized Genomic Testing for Melanoma.

  Reach is defined as registration of a personalized genomic testing for melanoma (PGT-M) test decision, either for or against testing (dichotomous outcome; test decision or no test decision). Additional assessments of reach include baseline survey completion and decision to pursue PGT-M testing.

  Three months from enrollment for each participant. Enrollment occurs on a rolling basis, to be completed August 2017.

Study Arms (2)

Control Group

NO INTERVENTION

Will simply complete surveys at baseline and at the three-month follow-up.

Web-based Module Group

EXPERIMENTAL

Participants will complete surveys at baseline. Participants in this arm will be provided with information to access and complete a web-based educational module (AKA the intervention), at the end of which will be given the opportunity to request and complete genetic testing for skin cancer. Participants who elect to complete the genetic testing will receive their genetic testing results along with a two-week follow-up call. All participants will also complete the survey at the three month follow-up.

Behavioral: Web-based Module Group

Interventions

Web-based Module Group BEHAVIORAL

Web-based Module Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to consent
• \<18 years old
• Prisoner

Sponsors & Collaborators

• University of New Mexico: lead
• Memorial Sloan Kettering Cancer Center: collaborator

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87113, United States

Location

Related Publications (27)

• 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.

  PMID: 20717041 BACKGROUND

• 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-Scarra G, Bressac-de Paillerets B, Calista D, Carrera C, Hansson J, Harland M, Hogg D, Hoiom 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.

  PMID: 20876876 BACKGROUND

• 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. doi: 10.1080/08858199409528281.

  PMID: 7917894 BACKGROUND

• 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.

  PMID: 21307933 BACKGROUND

• 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. doi: 10.1207/s15430154jce2004_13.

  PMID: 16497137 BACKGROUND

• 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. No abstract available.

  PMID: 18427057 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 19596487 BACKGROUND

• 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.

  PMID: 22888347 BACKGROUND

• 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.

  PMID: 21921576 BACKGROUND

• 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.

  PMID: 19474294 BACKGROUND

• 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.

  PMID: 20026844 BACKGROUND

• 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.

  PMID: 18417972 BACKGROUND

• 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. doi: 10.1038/gim.2012.22.

  PMID: 22481132 BACKGROUND

• 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.

  PMID: 21795499 BACKGROUND

• 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.

  PMID: 22962407 BACKGROUND

• 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.

  PMID: 19142859 BACKGROUND

• Pagan 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.

  PMID: 19944919 BACKGROUND

• 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. doi: 10.1067/mjd.2002.120450.

  PMID: 12077590 BACKGROUND

• 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.

  PMID: 18366057 BACKGROUND

• 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.

  PMID: 20878831 BACKGROUND

• 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.

  PMID: 20644034 BACKGROUND

• 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.

  PMID: 19752639 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 19863770 BACKGROUND

• 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.

  PMID: 19729884 BACKGROUND

• Hay JL, Zielaskowski K, Meyer White K, Kaphingst K, Robers E, Guest D, Sussman A, Talamantes Y, Schwartz M, Rodriguez VM, Li Y, Schofield E, Bigney J, Hunley K, Buller D, Berwick M. Interest and Uptake of MC1R Testing for Melanoma Risk in a Diverse Primary Care Population: A Randomized Clinical Trial. JAMA Dermatol. 2018 Jun 1;154(6):684-693. doi: 10.1001/jamadermatol.2018.0592.

  PMID: 29801061 DERIVED

MeSH Terms

Conditions

Melanoma; Skin Neoplasms

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. Jennifer Hay
• Organization: Memorial Sloan Kettering Cancer Center

hayj@mskcc.org

646-888-0039

Study Officials

• Marianne Berwick, PhD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

• Jennifer Hay, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 19, 2017
• First Posted: April 26, 2017
• Study Start: August 26, 2015
• Primary Completion: August 18, 2017
• Study Completion: August 31, 2017
• Last Updated: December 5, 2024
• Results First Posted: November 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)