Evaluating an Alternative Clinical Genetics Cancer Care Deliver Model: A Pilot Study of Patient Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,488
- 试验地点
- 1
- 主要终点
- baseline to post-results change in distress levels
研究概览
简要总结
To evaluate an alternative clinical genetics cancer care delivery model, using non-genetic providers to introduce and order genetic testing. 250 prostate and 250 pancreatic patients will be recruiting. They will undergo genetic testing and complete study questionnaires. Results from this pilot study will be used to inform the strategies used by the Clinical Risk Evaluation Program (CREP) Genetic Counelors (CGS) and GI/GU physicians to deliver genetic testing and return genetic risk information to patients with prostate or pancreatic cancer.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Penn patient age 18 years or older.
- •Diagnosed with prostate cancer or pancreas cancer.
- •Deemed to be clinically appropriate for multiplex genetic testing by their Urologic Cancer Program (GU) physician or Gastrointestinal Cancer Program (GI) physician at the Abramson Cancer
- •Agreed to receive clinical multiplex genetic testing from their physician.
- •English-fluent; the surveys were designed and validated in English and are not currently available in other languages.
排除标准
- •• Patients who do not or will not receive their ongoing cancer care at Penn
- •Major psychiatric illness or cognitive impairment that in the judgment of the study investigators or study staff would preclude study participation.
- •Any patients who are unable to comply with the study procedures as determined by the study investigators or study staff.
结局指标
主要结局
baseline to post-results change in distress levels
时间窗: 3 months
Change in distress levels (HADS-Anxiety) from Baseline to Time point #3 (3 months post-disclosure) measured as an effect size among participants who receive a pathogenic variant(s), no pathogenic variant(s), and variant(s) of uncertain significance
次要结局
未报告次要终点