Stand up to Cancer: MAGENTA (Making Genetic Testing Accessible)
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 5,200
- 试验地点
- 2
- 主要终点
- Mean cancer stress scores
研究概览
简要总结
This randomized clinical trial studies how well online genetics educational video with or without pre- and/or post-telephone genetics counseling works in assessing cancer-risk distress in patients with triple negative breast cancer. Online genetic education and telephone genetic counseling may help the doctors learn the stress a person feels about their risk of cancer.
详细描述
PRIMARY OBJECTIVES:
1. To test the effects of online genetic education versus telephone genetic counseling on cancer-risk distress.
SECONDARY OBJECTIVES:
- To test the effects of online genetic education versus telephone genetic counseling on testing completion rates.
- To evaluate the role of psychological and social variables in women's reactions to genetic testing for ovarian cancer risk with variable education strategies.
- To consider the effects of variations of genetic education/counseling on genetic knowledge, satisfaction with the decision to undergo testing, and family communication.
- To examine the cancer screening and prevention behaviors, as well as cascade testing behaviors among patients who tested positive for a pathogenic variant.
- To determine factors contributing to non-completion of genetic testing in subjects enrolled in a genetic testing trial.
- To determine the impact of pre- and/or post-test genetic counseling on family communication, genetic testing concerns and screening behaviors.
OUTLINE: Patients are randomized into 1 of 4 arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 30 or older. Note: Participants must meet each of Criteria 1-
- •Have access to a healthcare provider and be willing to share genetic results with that provider
- •Have at least one ovary
- •Have a valid United States mailing address for receipt of saliva kit
- •Participants must meet any one of the following 6 criteria:
- •Diagnosed with breast cancer at age 45 or younger
- •Diagnosed with triple negative (negative for estrogen receptor, progesterone receptor and not human epidermal growth factor receptor 2 [Her2] amplified) breast cancer at 60 or younger
- •Have one blood relative with a mutation in BRCA1, BRCA2, BRIP1, PALB2, RAD51C, RAD51D, BARD1, MSH2, MSH6, MLH1, or PMS2
- •Have one relative with ovarian cancer
- •Have at least 2 relatives with breast cancer on the same side of the family, one of which is =< 50 years of age
- •Have one male relative with breast cancer
排除标准
- •Personal history of ovarian cancer
- •Unable to read, speak, and understand English
- •Unable to provide informed consent
- •Unwilling to complete baseline and follow-up questionnaires
- •Unable to access the internet
- •Previous genetic testing or counseling regarding cancer risk
- •Previous bone marrow transplant
- •Previous blood transfusion (7 days prior to genetic testing)
- •Active hematologic malignancy (cancer that begins in blood-forming tissue, such as leukemia or lymphoma)
研究组 & 干预措施
Arm A (online education)
Patients watch genetic testing online educational video and receive genetic testing online test results report.
干预措施: Educational Intervention (Other)
Arm A (online education)
Patients watch genetic testing online educational video and receive genetic testing online test results report.
干预措施: Laboratory Biomarker Analysis (Other)
Arm A (online education)
Patients watch genetic testing online educational video and receive genetic testing online test results report.
干预措施: Questionnaire Administration (Other)
Arm B (online education, post telephone counseling)
Patients watch genetic testing online educational video, receive genetic testing online test results report, and post-telephone genetic counseling.
干预措施: Educational Intervention (Other)
Arm B (online education, post telephone counseling)
Patients watch genetic testing online educational video, receive genetic testing online test results report, and post-telephone genetic counseling.
干预措施: Genetic Counseling (Other)
Arm B (online education, post telephone counseling)
Patients watch genetic testing online educational video, receive genetic testing online test results report, and post-telephone genetic counseling.
干预措施: Laboratory Biomarker Analysis (Other)
Arm B (online education, post telephone counseling)
Patients watch genetic testing online educational video, receive genetic testing online test results report, and post-telephone genetic counseling.
干预措施: Questionnaire Administration (Other)
Arm C (online education, pre- and post-telephone counselling)
Patients watch genetic testing online educational video, receive pre-telephone genetic counseling, genetic testing online test results report, and post-telephone genetic counseling.
干预措施: Educational Intervention (Other)
Arm C (online education, pre- and post-telephone counselling)
Patients watch genetic testing online educational video, receive pre-telephone genetic counseling, genetic testing online test results report, and post-telephone genetic counseling.
干预措施: Genetic Counseling (Other)
Arm C (online education, pre- and post-telephone counselling)
Patients watch genetic testing online educational video, receive pre-telephone genetic counseling, genetic testing online test results report, and post-telephone genetic counseling.
干预措施: Laboratory Biomarker Analysis (Other)
Arm C (online education, pre- and post-telephone counselling)
Patients watch genetic testing online educational video, receive pre-telephone genetic counseling, genetic testing online test results report, and post-telephone genetic counseling.
干预措施: Questionnaire Administration (Other)
Arm D (online education, pre-telephone counseling)
Patients watch genetic testing online educational video, receive pre-telephone genetic counseling, and genetic testing online test results report.
干预措施: Educational Intervention (Other)
Arm D (online education, pre-telephone counseling)
Patients watch genetic testing online educational video, receive pre-telephone genetic counseling, and genetic testing online test results report.
干预措施: Genetic Counseling (Other)
Arm D (online education, pre-telephone counseling)
Patients watch genetic testing online educational video, receive pre-telephone genetic counseling, and genetic testing online test results report.
干预措施: Laboratory Biomarker Analysis (Other)
Arm D (online education, pre-telephone counseling)
Patients watch genetic testing online educational video, receive pre-telephone genetic counseling, and genetic testing online test results report.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Mean cancer stress scores
时间窗: Up to 4 years
Mean cancer stress scores are measured on the Impact of Events Scale (IES), a 15-item self-report measure that assesses subjective distress caused by traumatic events, which may include a positive genetic test result.There are two subscales, Intrusion and Avoidance, used to calculate a total. The range for Intrusion is 0-35 and the range for Avoidance is 0-40. The range of the total score is 0-75. Higher scores reflect more stressful impact, and therefore, a worse outcome. Subscales are summed to compute the total score.
次要结局
未报告次要终点