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临床试验/NCT05018156
NCT05018156已完成不适用

Pilot Implementation Study of a Default Genetics Referral Process for Patients With Young-Onset Colorectal Cancer

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2021年11月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
53
试验地点
2
主要终点
Genetics referrals

研究概览

简要总结

The investigators will perform a pilot implementation study of a default genetics referral process among patients with young-onset CRC diagnosed between ages 40 and 49.

详细描述

The incidence of young-onset colorectal cancer (CRC) - defined as a diagnosis of CRC prior to age 50 - has increased at alarming rates in recent years. Over 75% of cases occur in patients diagnosed between 40-49 years old, a group that is not traditionally included in young adult cancer initiatives tailored only to patients up to 39 years of age. Young age of CRC onset is a defining feature of hereditary CRC syndromes; as such, the National Comprehensive Cancer Network and American College of Medical Genetics and Genomics recommend germline genetics evaluations for all patients diagnosed with CRC under the age of 50. However, multiple studies have shown suboptimal rates and racial and socioeconomic disparities in guideline-recommended genetics evaluations.

In this pilot implementation study, the investigators aim to develop, implement, and evaluate the effects of a default genetics referral process among patients with young-onset CRC diagnosed between 40-49 years old. The investigators hypothesize that by applying defaults, or pre-selected choices, to minimize the cognitive effort that patients and clinicians use to make decisions, default referrals will improve rates of genetics referrals while reducing existing racial and socioeconomic disparities. The investigators will implement this intervention at five academic and community hospitals within Penn Medicine that serve a racially, socioeconomically, and geographically diverse patient population. The investigators will use an automated electronic health record-based algorithm to identify eligible patients, after which default referrals for genetic risk evaluation will be made unless patients or their oncology clinicians opt out. The investigators will rigorously evaluate the impact of this default genetics referral process using mixed methods leveraging models and frameworks from the field of implementation science.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
40 Years 至 49 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Newly diagnosed with colon or rectal adenocarcinoma
  • Between 40-49 years old at the time of index cancer diagnosis
  • At least two visits at Penn Medicine for the evaluation or treatment of the index cancer

排除标准

  • Diagnosis of in situ cancer
  • Known genetic predisposition to cancer
  • Genetic testing after index cancer diagnosis

结局指标

主要结局

Genetics referrals

时间窗: 3 months

The number of patients who are ultimately referred to genetics divided by the total number of eligible patients

次要结局

  • Scheduled genetics evaluations(3 months)
  • Completed genetics evaluations(3 months)
  • Genetic testing(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kelsey Lau-Min, MD

Hematology/Oncology Fellow

University of Pennsylvania

研究点 (2)

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