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NCT03130569: SOMBRA

Skin Health Online for Melanoma: Better Risk Assessment

Completed NA Results posted Last updated 5 December 2024
What this trial tests

NA trial testing Web-based Module Group in Melanoma (Skin) in 600 participants. Completed in 31 August 2017.

Timeline
26 August 2015
Primary endpoint
18 August 2017
31 August 2017

Quick facts

Lead sponsorUniversity of New Mexico
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeother
Enrollment600
Start date26 August 2015
Primary completion18 August 2017
Estimated completion31 August 2017
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of New Mexico

Who can join

18 and older, any sex, with Melanoma (Skin). Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Reach of Personalized Genomic Testing for Melanoma. Primary · Three months from enrollment for each participant. Enrollment occurs on a rolling basis, to be completed August 2017.

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.

GroupValue95% CI
Control Group0
Web-Based Module Group204
Control Group0
Web-Based Module Group295

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Interest and Uptake of MC1R Testing for Melanoma Risk in a Diverse Primary Care Population: A Randomized Clinical Trial.
    Hay JL, Zielaskowski K, Meyer White K, Kaphingst K, et al · · 2018 · cited 21× · PMID 29801061 · DOI 10.1001/jamadermatol.2018.0592
  2. Behavioral and Psychological Outcomes Associated with Skin Cancer Genetic Testing in Albuquerque Primary Care.
    Hay JL, Kaphingst KA, Buller D, Schofield E, et al · · 2021 · cited 10× · PMID 34439206 · DOI 10.3390/cancers13164053
  3. Exploring the role of cancer fatalism and engagement with skin cancer genetic information in diverse primary care patients.
    Hay JL, Wu Y, Schofield E, Kaphingst K, et al · · 2024 · cited 1× · PMID 38546209 · DOI 10.1002/pon.6331
  4. Prospective changes in primary care patients' family communication after skin cancer genetic test offer.
    Salafia C, Banerjee S, Hamilton JG, Schofield E, et al · · 2025 · PMID 40584153 · DOI 10.1016/j.pecinn.2025.100409
  5. Effect of Superstitious Beliefs and Risk Intuitions on Genetic Test Decisions.
    Riley KE, Sussman AL, Schofield E, Guest DD, et al · · 2022 · PMID 34455851 · DOI 10.1177/0272989x211029272

Verify or expand the search:

Other recruiting trials for Melanoma (Skin)

Currently open trials in the same condition.

Other University of New Mexico trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03130569.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing