Genetic Counseling for Breast Cancer Survivors (GC for BC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 157
- 试验地点
- 2
- 主要终点
- Part 2: Rate of Participation
研究概览
简要总结
The purpose of this study is to review and evaluate the effectiveness of new educational materials (informational booklet & DVD) that promote participation in genetic counseling among breast cancer survivors.
There are two phases to this study:
Part 1 - reviewing the newly developed educational materials, and Part 2 - evaluating the effectiveness of the newly developed educational materials
详细描述
Part 1: Intervention Development
Aim 1: Develop a psychoeducational intervention (PEI) for high-risk breast cancer survivors about genetic counseling (GC) and hereditary breast and ovarian cancer (HBOC).
Part 2: Intervention Pilot
Aim 2: Assess the feasibility and acceptability of a PEI from the perspective of the BC patients and health care professionals.
Exploratory Aim 3: Estimate the preliminary efficacy of the PEI compared to standard clinical care. We hypothesize that women in the intervention group will have higher uptake of GC, greater increases in knowledge, and more perceived benefits related to GC compared to the control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Part 1: Female breast cancer patients at Moffitt Cancer Center (MCC) are eligible to participate if they:
- •are > 18 years of age;
- •have no documented or observable psychiatric or neurological disorders that would interfere with study participation (e.g., dementia, psychosis);
- •are capable of speaking and reading standard English;
- •have not attended or scheduled an upcoming appointment for genetic counseling at the time of recruitment;
- •are within 18 months of their breast cancer (BC) diagnosis;
- •have a previous diagnosis of breast cancer or;
- •received a referral letter for GC from their MCC physician;
- •breast cancer at age 50 or below;
- •bilateral breast cancer;
- •multiple cancers except basal cell carcinoma;
- •triple negative breast cancer;
- •ovarian cancer or fallopian tube cancer at any age;
- •of Ashkenazi Jewish descent;
- •have 2 or more blood relatives diagnosed with breast cancer;
- •have any blood relatives diagnosed with bilateral breast cancer;
- •a first degree relative diagnosed with breast cancer below age 50;
- •have blood relatives diagnosed with ovarian cancer;
- •have 2 or more family members on the same side of the family with breast, ovarian, pancreatic, or prostate cancer;
- •have a known cancer gene mutation (such as BRCA 1/2;
- •have any male relatives diagnosed with breast cancer ; and
- •have a mailing address and working telephone number; and
- •provide written informed consent.
- •Part 2: Female BC patients at MCC are eligible to participate if they:
- •are > 18 years of age;
- •have no documented or observable psychiatric or neurological disorders that would interfere with study participation (e.g., dementia, psychosis);
- •are capable of speaking and reading standard English;
- •have not attended or scheduled an upcoming appointment for GC at the time of recruitment;
- •have a previous diagnosis of breast cancer or;
- •received a referral letter for GC from their MCC physician;
- •breast cancer at age 50 or below;
- •bilateral breast cancer;
- •multiple cancers except basal cell carcinoma;
- •triple negative breast cancer;
- •ovarian cancer or fallopian tube cancer at any age
- •of Ashkenazi Jewish descent;
- •have 2 or more blood relatives diagnosed with breast cancer;
- •have any blood relatives diagnosed with bilateral breast cancer;
- •a first degree relative diagnosed with breast cancer below age 50;
- •have blood relatives diagnosed with ovarian cancer;
- •have 2 or more family members on the same side of the family with breast, ovarian, pancreatic, or prostate cancer;
- •have a known cancer gene mutation (such as BRCA 1/2;
- •have any male relatives diagnosed with breast cancer ; and
- •have a mailing address and working telephone number; and
- •provide written informed consent.
排除标准
- 未提供
结局指标
主要结局
Part 2: Rate of Participation
时间窗: Up to 8 months
Participation in the Psychoeducational Intervention (PEI) group compared to the Factsheet group.
Part 1: Rate of Initial Survey Responses
时间窗: Up to 8 months
Intervention Development: Rate of feedback of draft materials required to complete a formative evaluation.
次要结局
- Rate of Impact(Up to 8 months)