Comparative Effectiveness of Interventions to Increase Guideline-based Genetic Counseling in Ethnically and Geographically Diverse Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 668
- 试验地点
- 2
- 主要终点
- Medically Verified Cancer Genetic Risk Assessment Uptake at 6 Months
研究概览
简要总结
GRACE is a randomized 3-arm trial to determine the comparative effectiveness of two remote cancer communication interventions: 1) a targeted generic print (TP) or 2) a tailored telephone-based counseling and navigation intervention (TCN). Post-award, the target sample size was revised to (n=642) with NIH permission.
详细描述
There is increasing evidence that activated and engaged patients who are equipped with necessary skills and information are more likely to follow through with recommended care and have better health outcomes at reduced costs. Identification of individuals at increased risk of hereditary breast and ovarian cancer (HBOC) is crucial for cancer survivors and their families to benefit from biomedical advances in cancer prevention, early detection, treatment and survivorship. The primary purpose of this study is to assess the feasibility and acceptability of two remote interventions aimed at promoting cancer genetic risk assessment (CGRA) for HBOC. The randomized controlled trial will have 3 arms: usual care (UC) vs. targeted generic print (TP) vs. tailored telephone counseling and navigation intervention (TCN).
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
- Single (Outcomes Assessor)
盲法说明
Randomization will be single blinded. Research team members who are assessing the outcomes will be blinded to study arm assignment. Research staff who are conducting follow-up interviews will be blinded to group assignment as much as possible. At the beginning of the follow-up interviews, the interviewer will request that the participant does not reveal the study arm they were assigned to.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Breast Cancer
- •Hispanic or non-Hispanic
- •21 years of age or older
- •English-speaking
- •Breast cancer history
- •breast cancer at the age of 50 or younger OR
- •triple-negative breast cancer OR
- •two or more primary breast cancers
- •Ovarian Cancer
- •Hispanic or non-Hispanic
- •21 years of age or older
- •English-speaking
- •History of ovarian, fallopian, or peritoneal cancer diagnosed at any age
排除标准
- •Have had prior genetic counseling or testing for hereditary breast and/or ovarian cancer
研究组 & 干预措施
Usual Care (UC)
Control
干预措施: Usual Care (UC) (Other)
Telephone Counseling & Navigation (TCN)
Telephone Counseling
干预措施: Telephone Counseling & Navigation (TCN) (Behavioral)
Mailed Targeted Print (TP)
Mailed Targeted Print
干预措施: Mailed Targeted Print (TP) (Behavioral)
结局指标
主要结局
Medically Verified Cancer Genetic Risk Assessment Uptake at 6 Months
时间窗: 6 months following the interventions for TP and TCN, and 6 months following the baseline survey for the UC arm.
Participants reported whether they had sought cancer CGRA (i.e. genetic counseling and/or testing) in surveys at the 6-month follow-up. Participants who reported receiving a CGRA were asked to provide written consent allowing research staff to obtain document of receipt of the genetic services.
次要结局
- Medically Verified Cancer Genetic Risk Assessment Uptake at 12 Months(12 months following the interventions for TP and TCN, and 12 months following the baseline survey for the UC arm.)
- Decisional Conflict for CGRA: SURE Scale(1 month following the interventions for TP and TCN, and 1 months following the baseline survey for the UC arm.)
- Cancer Genetic Risk Assessment Intention(1 month following the interventions for TP and TCN, and 1 months following the baseline survey for the UC arm.)
研究者
Anita Y. Kinney, PhD, RN
Study Principal Investigator; Associate Director for Cancer Health Equity
Rutgers, The State University of New Jersey