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临床试验/NCT03130569
NCT03130569已完成不适用

Personalized Genomic Testing for Skin Cancer - Maximizing Utility and Reach

University of New Mexico2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2015年8月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
600
试验地点
2
主要终点
Reach of Personalized Genomic Testing for Melanoma.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Unable to consent
  • <18 years old

研究组 & 干预措施

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.

干预措施: Web-based Module Group (Behavioral)

结局指标

主要结局

Reach of Personalized Genomic Testing for Melanoma.

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marianne Berwick

Professor

University of New Mexico

研究点 (2)

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