Telegenetics or In-Person Genetic Counselling: A Comparison of Clinical Outcomes and Cost
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Genomics Outcome Scale
研究概览
简要总结
This study aims to compare clinical outcomes (informed choice and genetic counselling outcomes) and cost (provider and patient time, travel, and telehealth platform) between telegenetics and in-person genetic counselling.
详细描述
This study will compare the patient-reported outcomes of telegenetics with in-person consultations for participants considering germline testing for HBOC or Lynch syndrome. It will clarify if telegenetics is a feasible and non-inferior alternative to in-person cancer genetic counselling. Participant responses are important stakeholder views to guide the design of telegenetics to become a mainstream service delivery model welcomed by patients.
It aims to recruit 150 prospective consecutive patients attending genetic counselling for Hereditary Breast and Ovarian Cancer (HBOC) and Lynch Syndrome in Clinical Genetic Services (CGS) at National Cancer Centre Singapore (NCCS).
Upon completion of the genetic consultation appointments, patients will be completing a series of questions evaluating cognitive and psychosocial outcomes either via hardcopy in-person or online internet-facing questionnaire.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 21 years old.
- •Patients referred to CGS at NCCS for HBOC or Lynch syndrome pre-test genetic counselling.
- •Able to read and understand the English Language.
- •Able to consent and agree to be randomized to either telegenetics or in-person genetic counselling.
排除标准
- •Under the age of 21 years old.
- •Patients who require genetic results urgently.
- •Cognitive difficulty/ impairment or current psychiatric or physical illness (visual/ hearing/ neurological) which impairs sound judgement and accurate reporting of medical history over video consultation.
研究组 & 干预措施
Patients referred to CGS at NCCS for HBOC or Lynch syndrome pre-test genetic counselling.
Patients attending genetic counselling for Hereditary Breast and Ovarian Cancer (HBOC) and Lynch Syndrome in Clinical Genetic Services (CGS) at National Cancer Centre Singapore (NCCS)
干预措施: Patients referred to CGS at NCCS for HBOC or Lynch syndrome pre-test genetic counselling. (Other)
结局指标
主要结局
Genomics Outcome Scale
时间窗: Up to 2 weeks after consultation
Patient reported outcomes will be compared with a 6 item Genomics Outcome Scale (GOS) across five domains (decisional control, cognitive control, behavioral control, emotional regulation and hope) which are rated on a 5-point Likert scale ranging from "strongly agree" to "strongly disagree". Scores are summed to provide an overall "empowerment" where higher scores equal higher levels of empowerment.
次要结局
- Telehealth Patient Survey(Up to 2 weeks after consultation)
- Adapted Multidimensional Measure of Informed Choice (MMIC) for Hereditary Breast and Ovarian Cancer (HBOC) and Lynch(Up to 2 weeks after consultation)
- Genetic Counselling Satisfaction Scale(Up to 2 weeks after consultation)