Methods for Increasing Genetic Testing Uptake in Michigan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 793
- 试验地点
- 1
- 主要终点
- Percentage of participants who complete clinical genetic testing at six months after randomization
研究概览
简要总结
The primary purpose of this study is to compare three interventions, two experimental and one standard of care (usual care), to see if the experimental interventions will increase the likelihood of a participant obtaining guideline-concordant genetic testing. Eligible participants will be randomized (assigned) to one of the following interventions: 1) Virtual genetics navigator, a mobile-optimized website, designed by the investigators, that delivers tailored messages and content; 2) two motivational interviewing (MI) telephone calls delivered by trained genetics health coaches; or 3) usual care.
详细描述
This trial will be conducted in partnership with the Michigan Department of Health and Human Services (MDHHS) and a network of oncology practices in Michigan, the Michigan Oncology Quality Consortium (MOQC).
As of April 2023 we were approved by our IRB to expand our inclusion criteria and recruitment cohort. This expansion will enhance our reach to individuals who are not in the acute stages of clinical care as well as individuals who are not in oncology care currently yet still qualify for genetic testing based on their family history of cancer alone or in combination with any personal cancer history. These expansions will also support the unburdening of oncology practices - who continue to face downstream, resource-limiting affects from the COVID-19 pandemic - across the state. The goal and aims of the study remain the same.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Able to speak and read English
- •Access to the internet
- •Completed the Family Health History Tool (FHHT)
- •Meeting clinical criteria for genetic evaluation due to any of the below:
- •Personal history of Breast cancer either:
- •i. Diagnosed under 50
- •ii. Personal or family history of triple negative breast cancer
- •iii. Ashkenazi Jewish ancestry
- •iv. Male proband
- •v. 1st or 2nd degree relative with ovarian cancer, pancreatic cancer, breast cancer diagnosed under 50, or male breast cancer
- •Personal history of prostate cancer either:
- •i. Diagnosed under 50
- •ii. Ashkenazi Jewish ancestry
- •iii. 1st or 2nd degree relative with ovarian cancer, pancreatic cancer, breast cancer diagnosed under 50, or male breast cancer
- •Personal history of any cancer or no personal history of cancer with either:
- •i. PREMM score ≥ 2.5%
- •ii. 1st degree relative with pancreatic, or male breast cancer
- •iii. 1st or 2nd degree relative with ovarian cancer
- •iv. 1st degree relative with any of these cancers diagnosed under 50: colon, endometrial, or breast
- •v. Ashkenazi Jewish ancestry and 1st or 2nd degree relative with breast cancer
- •Personal history of endometrial cancer diagnosed under 50
- •Personal history of colorectal cancer diagnosed under 50
- •Personal history of renal cancer diagnosed under 46
- •Personal history of sarcoma diagnosed under 46 and a 1st or 2nd degree relative with sarcoma, breast cancer, or brain cancer diagnosed under 56
- •Personal history of brain cancer diagnosed under 46 and a 1st or 2nd degree relative with sarcoma, breast cancer, or brain cancer diagnosed under 56
- •Personal history of any two of the following cancers with at least one of them diagnosed under 46: breast, sarcoma, or brain
- •Personal history of ovarian cancer
- •Personal history of pancreatic cancer
- •Personal history of adrenal cortical carcinoma
排除标准
- •Prior clinical germline genetic testing for cancer or already have an upcoming appointment scheduled with a genetics provider
研究组 & 干预措施
Arm 3 - Motivational interviewing (MI)
Participants receive up to 2 phone calls from trained genetics health coaches who provide information about genetic testing and use motivational interviewing to encourage participants to seek out clinical genetic testing.
干预措施: Motivational interviewing (MI) (Behavioral)
Arm 2 - Virtual genetics navigator
Participants receive access to an online genetics tool, the virtual genetics navigator, to help learn why and how to seek out genetic testing for hereditary cancer syndromes.
干预措施: Virtual genetics navigator (Behavioral)
Arm 1 - Usual care (UC)
Participants are provided with a link to the Michigan Department of Health and Human Services (MDHHS) informational website and are instructed to follow up with their oncology provider about genetic testing.
干预措施: Publicly available genetic testing resources (Other)
结局指标
主要结局
Percentage of participants who complete clinical genetic testing at six months after randomization
时间窗: 6 months after enrollment/randomization
The primary outcome is completion of genetic testing (yes/no) at 6 months after randomization by patient self-report.
Percentage of Participants Who Complete Clinical Genetic Testing at Six Months After Randomization
时间窗: 6 months after enrollment/randomization
The primary outcome is completion of genetic testing (yes/no) at 6 months after randomization by patient self-report.
次要结局
- Barriers to genetic testing, for participants who completed genetic testing(6 months and 12 months after enrollment/randomization)
- Motivators of genetic testing, for participants who did not yet complete genetic testing(6 months and 12 months after enrollment/randomization)
- Barriers to genetic testing, for participants who did not yet complete genetic testing(6 months and 12 months after enrollment/randomization)
- Motivators of genetic testing, for participants who completed genetic testing(6 months and 12 months after enrollment/randomization)
- Barriers to Genetic Testing, for Participants Who Completed Genetic Testing(6 months and 12 months after enrollment/randomization)
- Barriers to Genetic Testing, for Participants Who Did Not Yet Complete Genetic Testing(6 months and 12 months after enrollment/randomization)
- Motivators of Genetic Testing, for Participants Who Completed Genetic Testing(6 months and 12 months after enrollment/randomization)
- Motivators of Genetic Testing, for Participants Who Did Not Yet Complete Genetic Testing(6 months and 12 months after enrollment/randomization)