Genetic Counseling for Newly Diagnosed Breast Cancer Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 331
- 试验地点
- 6
- 主要终点
- Definitive surgery choice as measured by self-reported and medical record verification at 6 months after randomization
研究概览
简要总结
RATIONALE: Genetics education and counseling may help patients make treatment decisions. It is not yet known how genetic counseling or usual care influence patient treatment decisions for breast cancer.
PURPOSE: This randomized clinical trial is studying how well genetic counseling works compared to usual care in helping patients with newly diagnosed ductal carcinoma in situ, stage I, stage II, or stage IIIA breast cancer make treatment decisions.
详细描述
OBJECTIVES:
- Compare the impact of rapid genetic counseling (RGC) vs usual care on the medical decisions of women with newly diagnosed ductal carcinoma in situ or stage I-IIIA breast cancer.
- Compare the impact of these interventions on the quality of life and psychological well being of these patients.
- Determine baseline factors that predict who is most and least likely to benefit from RGC in patients undergoing these interventions.
- Compare the cost per quality adjusted life year saved from a societal perspective in patients undergoing these interventions.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating site. Patients are randomized to 1 of 2 interventional arms.
- Arm I (rapid genetic counseling): Patients undergo a 1½ hour genetic counseling session either in person or by telephone. Patients who undergo telephone counseling receive a booklet of visual aids and educational materials. Patient preferences and values are assessed immediately after counseling. Some patients may undergo BRCA1/2 status determination. Patients undergo follow-up telephone interviews at 1, 6, and 12 months.
- Arm II (usual care): Patients receive a packet of breast cancer treatment educational materials. Patient preferences and values are assessed 2 weeks later. Patients undergo follow-up telephone interviews as in arm I.
In both arms, quality of life is assessed at baseline and at 1, 6, and 12 months.
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
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Rapid genetic counseling
Following randomization, participants will be informed about whether they are assigned to Usual Care (UC) or Rapid Genetic Counseling (RGC). Participants in the UC arm can schedule a genetic counseling appointment at any time during the study if they wish. Participants in the RGC agree to obtain genetic counseling as soon as possible, before they make a definitive surgery decision. RGC can be accomplished by telephone or in-person. The RGC intervention is delivered by highly experienced genetic counselors at each site. This counseling is identical to our standard genetic counseling procedure for newly diagnosed patients. Immediate DNA collection via blood or buccal cell collection is available following counseling. Phone counseling participants will be been mailed a kit for DNA collection or have the option of having the sample collected at at LCCC.
干预措施: psychosocial assessment and care (Procedure)
Rapid genetic counseling
Following randomization, participants will be informed about whether they are assigned to Usual Care (UC) or Rapid Genetic Counseling (RGC). Participants in the UC arm can schedule a genetic counseling appointment at any time during the study if they wish. Participants in the RGC agree to obtain genetic counseling as soon as possible, before they make a definitive surgery decision. RGC can be accomplished by telephone or in-person. The RGC intervention is delivered by highly experienced genetic counselors at each site. This counseling is identical to our standard genetic counseling procedure for newly diagnosed patients. Immediate DNA collection via blood or buccal cell collection is available following counseling. Phone counseling participants will be been mailed a kit for DNA collection or have the option of having the sample collected at at LCCC.
干预措施: counseling intervention (Behavioral)
Rapid genetic counseling
Following randomization, participants will be informed about whether they are assigned to Usual Care (UC) or Rapid Genetic Counseling (RGC). Participants in the UC arm can schedule a genetic counseling appointment at any time during the study if they wish. Participants in the RGC agree to obtain genetic counseling as soon as possible, before they make a definitive surgery decision. RGC can be accomplished by telephone or in-person. The RGC intervention is delivered by highly experienced genetic counselors at each site. This counseling is identical to our standard genetic counseling procedure for newly diagnosed patients. Immediate DNA collection via blood or buccal cell collection is available following counseling. Phone counseling participants will be been mailed a kit for DNA collection or have the option of having the sample collected at at LCCC.
干预措施: educational intervention (Other)
Usual Care
Usual Care (UC) for newly diagnosed breast cancer patients does not typically include a pre-surgical genetic referral. These patients may obtain genetic counseling at their own discretion.
结局指标
主要结局
Definitive surgery choice as measured by self-reported and medical record verification at 6 months after randomization
时间窗: 1, 6, and 12 months
Decision outcomes as assessed by Decisional Conflict Scale Satisfaction with Decision Scale at 1 and 6 months after randomization
时间窗: 1 and 6 months
Distress as measured by Impact of Events Scale Brief Symptom Inventory at 1, 6, and 12 months after randomization
时间窗: 1, 6, and 12 months
Knowledge as assessed by Genetic Testing Knowledge Measure at 1 month after randomization
时间窗: 1 month
Quality of life as measured by functional assessment of cancer therapy for breast cancer (FACT-B) at 1, 6, and 12 months after randomization
时间窗: 1, 6, and 12 months
次要结局
- Cost effectiveness as measured by quality adjusted life years saved at 12 months after randomization(12 months)
研究者
Marc D Schwartz
Professor of Oncology
Georgetown University