Promoting Genetic Counseling Among African American Women With a Family History of Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Genetic Counseling Attendance
研究概览
简要总结
In the United States, carriers of hereditary genetic mutations have up to an 85% risk of developing breast cancer compared to 12% in the general population. Overall uptake of genetic services is generally low, particularly among high-risk African American (AA) women, who carry a disproportionate burden of breast cancer mortality. Further, although testing close relatives of individuals who test positive for a pathogenic variant might curtail breast cancer disparities attributable to hereditary risk, it is unclear how counseled or tested individuals influence their social and familial networks. Using a randomized control trial design, the objective of this research project is to test the effectiveness of a culturally targeted video, previously developed by our research team, on promoting genetic counseling attendance among AA women determined to be at high risk for breast cancer through cancer genetic risk assessment in a clinical setting. This study will also test how psychosocial factors (knowledge, intrinsic motivation, risk perception, and distress) impact the relationships between intervention exposures (video versus brochure) and compare the impact of intervention exposures on diffusion of knowledge about genetic counseling through social network analysis.
详细描述
Study Design. The investigator will conduct a randomized control trial single-blind control trial to test the effectiveness of a culturally targeted decision aid video to promote genetic counseling among African American determined to be high risk for breast cancer through cancer genetic risk assessment. Eligible patients will be randomly assigned to receive information about genetic counseling using a culturally targeted decision aid video (treatment group) or a brochure (control).
Research Protocol. As part of standard of care, patients will complete a cancer genetic risk assessment (CGRA) as part of intake on a tablet computer provided by the front desk clinic staff. CGRA results will be uploaded to the EMR, printed and given to a patient navigator. The patient navigator will approach patients, give them a recruitment flyer, information about the study, screen patients and obtain informed consent for women who choose to participate in the study. Based on computer-generated randomization (equal numbers in each arm), patients will be randomized to one of two groups to receive: 1) pretest, view decision aid video, and posttest or 2) pretest, genetic counseling brochure, and posttest. Both arms will be facilitated by patient navigators. Upon completion of posttest, patient navigators will ask women if they would like to make an appointment for genetic counseling, contact the provider for the order if not already in the EMR, make genetic counseling appointments for women who choose to attend, and monitor and collect follow-up data. All enrolled participants will receive a phone call at 4 weeks post-intervention to (a) verify counseling attendance through self-report and EMR extraction if applicable; (b) ask whether the patient was referred to genetic testing after her genetic counseling if applicable; and (c) ask whether other family members were referred to genetic services if applicable and (d) determine who in their social networks, if anyone, the participant told about genetic counseling, and if so, how this information was shared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Identify as African American
- •Are age 25 or older
- •Speak and understand English
- •Completed a cancer genetic risk assessment (CGRA) as part of clinic intake
- •Are classified as high risk for developing breast cancer per CGRA
- •Have not previously received genetic counseling
排除标准
- •Are not female
- •Do not identify as African American
- •Are age 24 or younger
- •Do not speak and understand English
- •Did not complete a cancer genetic risk assessment (CGRA) as part of clinic intake
- •Are not classified as high risk for developing breast cancer per CGRA
- •Have previously received genetic counseling
结局指标
主要结局
Genetic Counseling Attendance
时间窗: 52 weeks
Compare the effects of intervention vs. control arm on genetic counseling attendance among African American women recommended for genetic counseling through cancer genetic risk assessment. Assessed via EMR and survey at follow-up. 2-item (Did patient complete genetic counseling appointment? A) Self-report and B) EMR) 1 items assessing familial referral to genetic counseling or testing
次要结局
- Distress Associated with Genetic Counseling and Breast Cancer Risk(52 weeks)
- Decision Aid Usability(52 weeks)
- Knowledge about Genetic Counseling(52 weeks)
- Intrinsic Motivation for Genetic Counseling Attendance(52 weeks)
- Risk Perception Associated with Breast Cancer(52 weeks)
- Diffusion of Knowledge(56 weeks)
研究者
Vida Henderson
Principal Investigator
Fred Hutchinson Cancer Center