Cancer Genetic Counseling: Telephone Versus Standard In-person Delivery. A Randomized Trial (GEO-STAR)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 724
- 试验地点
- 2
- 主要终点
- "Multidimensional Impact of Cancer Risk Assessment" questionnaire
研究概览
简要总结
The purpose of the GEO-STAR randomized non-inferiority trial is to compare the outcome of post-test telephone cancer genetic counseling with standard in-person cancer genetic counseling. We hypothesize that telephone counseling is non-inferior by outcome if compared to standard in-person counseling.
详细描述
Consecutive patients undergoing pre-test cancer genetic counseling and cancer genetic testing, during the study period, will be eligible to participate. During the pre-test genetic counseling, demographic data, family and personal medical history will be collected and pedigree will be drawn. Available participants will provide written informed consent. They will be then randomized in blocks of ten participants using an online system (http://wwwservizi.regione.emilia-romagna.it/generatore/).
The study is open label; thus, patients and investigators will not be blinded to treatment allocation due to the study nature intervention.
After randomization, participants will be scheduled for post-test genetic counseling session. Participants randomized to usual care will receive standard in-person result disclosure. Participants randomized to telephone counseling will be scheduled for telephone post-test counseling sessions. One-week after completing the post-test genetic counseling session, the survey package will be sent by email to participants to assess impact and satisfaction with post-test counseling.
Genetic counselors delivering post-test genetic counseling will complete the questionnaire immediately after the post-test 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
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients over 18 years of age inclusive at the time of the study;
- •Patients must have undergone an in-person pre-test genetic counseling session;
- •Patients must have undertaken cancer genetic testing;
- •Patients must be able to speak Italian fluently;
- •Patients must have got an email address.
排除标准
- •Patients unable to provide informed consent, for example due to mental incapacity or active psychotic illness.
结局指标
主要结局
"Multidimensional Impact of Cancer Risk Assessment" questionnaire
时间窗: Seven days after the post-test genetic counseling session
Impact of post-test counseling on patients. The "Multidimensional Impact of Cancer Risk Assessment" questionnaire measures distress, uncertainty and positive experiences associated to cancer genetic testing. A version adapted to the Italian context will be used, where a single item related to insurance has been removed because not applicable to the Italian Health System. The resulting possible scores range from 0 to 100. Higher scores indicate more negative impacts of cancer risk assessment.
"Genetic Counselor process Questionnaire"
时间窗: Immediately after the post-test genetic counseling session
Professionals perceptions measured by the Genetic Counselor process Questionnaire completed by professionals who provided the post-test genetic counseling. The range of scores is from 4 to 20. Higher scores indicate positive perception of the genetic counselor.
"Patient perceptions of the genetic counseling questionnaire"
时间窗: Seven days after the post-test genetic counseling session
Impact of post-test counseling on patients. The range of scores is from 8 to 31. Higher scores indicate positive perception of the genetic counseling session.
次要结局
- Influence of sociodemographic and medical history on genetic counseling outcomes(Data collection during pre-test genetic counseling session)
- Impact of logistics on genetic counseling preferences(Data collection during the pre-test genetic counseling session)
研究者
Daniela Turchetti
Prof.
IRCCS Azienda Ospedaliero-Universitaria di Bologna