Genetic Counseling Processes and Outcomes Among Males With Prostate Cancer (ProGen)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 662
- 试验地点
- 3
- 主要终点
- Prevalence of germline mutations in males with prostate cancer
研究概览
简要总结
This randomized controlled trial aims to evaluate the impact of pre-test video education and post-test genetic counseling as compared to in-person pre-test genetic counseling in males with advanced prostate cancer.
详细描述
Participants will be randomized to either pre-test video education and post-test genetic counseling or in-person pre-test genetic counseling. Outcomes evaluated are: prevalence of germline mutations, uptake of genetic testing, satisfaction with testing, knowledge of multi-gene panels, distress, result disclosure to relatives, and the impact on personal or family medical care. Through this study, the investigators will learn about the inherited causes of prostate cancer, and how and when genetic testing should be offered to this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- Male
- 接受健康志愿者
- 否
入选标准
- •Metastatic prostate cancer (hormone-sensitive, de novo, or castration resistant)
- •Localized prostate cancer with Gleason score ≥8
- •Rising PSA after prostatectomy or radiation with PSA doubling time ≤ 6 months
- •Persistent PSA after prostatectomy for PSA ≥ 0.2 ng/mL observed in testing at least 1 week apart
- •Prostate cancer diagnosed at age ≤ 55 years
- •Prostate cancer and a personal history of prior malignancy that does not include non-melanoma skin cancer or superficial bladder cancer.
- •Prostate cancer diagnosis (any grade/stage) or prostate biopsy with high grade PIN or small acinar proliferation and a family history potentially indicating a germline mutation (e.g. breast cancer diagnosed at age ≤ 50, ovarian, pancreatic, uterine, colorectal, prostate cancer or sarcoma, in one or more first or second-degree relatives)
排除标准
- •Previous cancer genetic testing or counseling, or prior germline multigene panel testing. Previous tumor sequencing is acceptable if no genetic counseling took place.
- •Localized prostate cancer previously treated and in remission for > 2 years unless family history potentially indicates a germline mutation.
- •Active hematologic malignancy (e.g. CLL)
研究组 & 干预措施
Traditional pre-test genetic counseling
- In-person consultation with licensed genetic counselor at the Center for Cancer Genetics and Prevention before genetic testing
- Participant is given a pamphlet introducing prostate cancer genes, genetic testing
- Participant is sent electronic family history tool
- Participant is given the "Genetic Testing Information for Decision Making" packet. After the genetic counseling session, patient is asked if they would like to proceed with genetic testing.
干预措施: Traditional pre-test genetic counseling (Other)
Pre-test video education
- Participant is given a pamphlet that describes the basics of prostate cancer genes, genetic testing
- Participant is sent electronic family history tool
- Participant is approached in clinic by research staff at a pre-planned time
- The patient is given the "Genetic Testing Information for Decision Making" packet
- The pre-test video education is a short video. Information will be provided about the basics of genetics and mutations, the potential benefits, risks, and limitations of genetic testing, and the possible results the participant may receive
干预措施: Pre-test video education (Other)
结局指标
主要结局
Prevalence of germline mutations in males with prostate cancer
时间窗: 2 years
The proportion of participants who test positive for pathogenic or likely pathogenic variants
次要结局
- Secondary or other primary (non-prostate) malignancies(2 years)
- Genetic testing satisfaction score(at time of post-counseling/video pre-result disclosure and at 1 month post-result disclosure)
- Intent to disclose genetic test results(pre-result disclosure)
- Genetic testing uptake(2 years)
- Multidimensional Impact of Cancer Risk Assessment score and subscales(1 and 4 months post-result disclosure)
- Knowledge of multigene panel testing score(4 months post-result disclosure)
- Family communication for those who tested positive for a genetic mutation(1 and 4 months post-result disclosure)
研究者
Huma Rana, MD
Principal Investigator
Dana-Farber Cancer Institute