Bridging Geographic Barriers: Remote Cancer Genetic Counseling for Rural Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,012
- 试验地点
- 2
- 主要终点
- Determine the non-inferiority/equivalency of telephone genetic counseling to standard in-person genetic counseling
研究概览
简要总结
Individuals living in geographically underserved areas encounter considerable barriers to access of quality cancer genetic services. Although in-person genetic counseling has generally been accepted as the standard of care, the use of telecommunications to deliver clinical genetic services may help reduce this disparity in access to such services. However, before the widespread adoption of telephone-delivered cancer genetic services occurs, it is critical to analyze the efficacy and safety of this mode of communication. This two-group randomized equivalency/non-inferiority trial will determine whether telephone-based cancer genetic counseling is an acceptable alternative to the traditional in-person mode among women who have a personal or family history of breast and/or ovarian cancer strong enough to warrant genetic counseling and testing. This study's findings will provide important information to cancer centers and cancer control policies about the safety, efficacy, and costs of delivering telephone-based clinical cancer genetic services for geographically challenged women at risk for having Breast Cancer susceptibility gene (BRCA) 1/2 mutations.
详细描述
Following confirmation of eligibility and completion of baseline surveys, participants will be randomly assigned to one of the study arms by the project coordinator, using a computer-generated allocation algorithm on the basis of a randomization blocks method using four, six or eight participants in each block.
In-person and telephone counseling will be delivered by the same board-certified genetic counselors using a guideline-concordant semi-structured protocol that will allow for personalization of counseling.
Participants randomly assigned to telephone counseling will be mailed packets that include a sealed envelope containing an educational brochure about hereditary breast and ovarian cancer genetic counseling with visual aids. At the time of their session, participants will review the brochure and genetic counselors will use visual aids to explain breast-ovarian cancer genetics. Women receiving in-person counseling will be given the same materials during their session at the community clinic.
For women who elect to have testing, those who have telephone counseling will be sent a genetic test kit; those who have in-person counseling will have the option of giving a sample immediately at the clinic, or will be given a test kit with the same instructions as those in the telephone-counseling group.
When BRCA test results become available, participants will be offered individual post-test counseling with the same genetic counselor who conducted the pretest session.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 74 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Utah resident
- •Meets National Comprehensive Cancer Network (NCCN) guidelines for hereditary breast/ovarian cancer syndrome (personal and/or family history of breast and/or ovarian cancer, or is a member of a family with a known positive BRCA1/BRCA2 mutation).
排除标准
- •Has had genetic counseling and/or BRCA 1/2 testing
- •Physically or mentally unable to complete telephone surveys, telephone or in-person counseling or provide informed consent.
- •Unable to read and speak English fluently
- •Unable to travel to in-person genetic counseling session (17 in-person sites throughout Utah)
- •Male gender
结局指标
主要结局
Determine the non-inferiority/equivalency of telephone genetic counseling to standard in-person genetic counseling
时间窗: 6 &12-month follow-up
1. Compare utilization of BRCA1/BRCA2 testing among telephone genetic counseling relative to in-person genetic counseling. 2. Determine the safety and efficacy of telephone genetic counseling relative to in-person genetic counseling by evaluating psychological and quality of life outcomes. 3. Compare communication-related and decision-making outcomes among telephone genetic counseling relative to in-person genetic counseling.
次要结局
- Determine the feasibility of the intervention(1 week pre-test, 1 week post-test, 6 & 12 month follow-ups)
研究者
Anita Kinney
Professor
University of Utah