Improving Care After Inherited Cancer Testing (IMPACT) Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 720
- 试验地点
- 2
- 主要终点
- Change in CRM
研究概览
简要总结
The IMPACT Study seeks to refine and evaluate the effectiveness of interventions on improving guideline-adherent cancer risk management (CRM) and family communication (FC) of genetic test results for individuals with a documented pathogenic/likely pathogenic (P/LP) variant, and FC of family cancer history for individuals with a variant of uncertain significance (VUS) in an inherited cancer gene.
详细描述
Through recruitment of a racially, geographically, and socioeconomically diverse sample of patients, we will achieve the following aims:
- Evaluate factors associated with access to genetic risk assessment, counseling, and testing services.
- Conduct a randomized controlled trial to assess the effectiveness of interventions on improving guideline-adherent CRM and FC of genetic test results among individuals with a P/LP variant in an inherited cancer gene.
- Conduct a pilot study to assess the effectiveness of an intervention on improving FC of family cancer history among individuals with a VUS in an inherited cancer gene.
- Create and pilot an adaptive intervention to tailor resources to promote CRM and FC.
- Document and compare multiple implementation outcomes across the different interventions to maximize their effectiveness and improve reach to underserved populations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 是
入选标准
- •English-speaking men and women aged 18 years or older
- •Not adopted (i.e., have information about their biological relatives)
- •Have access to internet and a computer, tablet, or smartphone
- •Documented pathogenic/likely pathogenic variant in an inherited cancer gene that has CRM guidelines listed in the National Comprehensive Cancer Network (NCCN) Genetic/Familial Panel focused on Breast, Ovarian, and Pancreatic or Colorectal cancers
- •Must meet at least one of the following criteria:
- •Intervention A (GeneSHARE) criteria: Have at least one at-risk adult, living relative who either:
- •has not been told about the genetic test result by the participant
- •has not had their own genetic testing
- •Intervention B (LivingLabReport) criteria: Are non-adherent (i.e., either undertreatment or overtreatment) to at least one of the current NCCN CRM guidelines or if currently adherent, require ongoing cancer screening
- •VUS Pilot Study Eligibility: All VUS pilot study participants will be autonomous adults who are capable of participating in the study. Eligibility criteria include:
- •English-speaking men and women aged 18 years or older
- •Not adopted (i.e., have information about their biological relatives)
- •Have access to internet and a computer, tablet, or smartphone
- •Documented VUS in an inherited cancer gene
排除标准
- 未提供
结局指标
主要结局
Change in CRM
时间窗: 12 months
Ongoing guideline-adherent CRM or a change towards guideline-adherent CRM per National Comprehensive Cancer Network (NCCN) CRM guidelines based on genetic test results as measured by survey data and verified through medical records where possible and/or appropriate.
Change in FC of genetic test results (if P/LP variant result) or family history of cancer (if VUS result)
时间窗: 12 months
Having at least one additional at-risk adult, living relative with whom the participant has shared their test result, information about testing, or family history of cancer for the first time or has subsequently followed up with a relative
次要结局
未报告次要终点
研究者
Tuya Pal
Associate Director for Cancer Health Disparities
Vanderbilt-Ingram Cancer Center