Skin Health Online for Melanoma: Better Risk Assessment (SOMBRA)

October 5, 2017 updated by: Marianne Berwick, University of New Mexico

Personalized Genomic Testing for Skin Cancer - Maximizing Utility and Reach

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

628

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Mexico
      • Albuquerque, New Mexico, United States, 87113
        • University of New Mexico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Will simply complete surveys at baseline and at the three-month follow-up.
Experimental: Web-based Module Group
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Personal Utility of Personal Genomic Testing for Skin Cancer
Time Frame: Three months from enrollment for each participant. Enrollment occurs on a rolling basis, to be completed August 2017.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of New Mexico

Collaborators

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Jennifer Hay, PhD, Memorial Sloan Kettering Cancer Center
  • Principal Investigator: Marianne Berwick, PhD, University of New Mexico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2015

Primary Completion (Actual)

August 18, 2017

Study Completion (Actual)

August 31, 2017

Study Registration Dates

First Submitted

April 19, 2017

First Submitted That Met QC Criteria

April 21, 2017

First Posted (Actual)

April 26, 2017

Study Record Updates

Last Update Posted (Actual)

October 6, 2017

Last Update Submitted That Met QC Criteria

October 5, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-050

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Melanoma (Skin)

Clinical Trials on Web-based Module Group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Senegal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe