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临床试验/NCT04145388
NCT04145388进行中(未招募)不适用

Systems-Level Capture of Family History Data to Assess Risk of Cancer

Kaiser Permanente1 个研究点 分布在 1 个国家目标入组 18,623 人开始时间: 2020年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
18,623
试验地点
1
主要终点
Number of patients identified at high risk of cancer

研究概览

简要总结

This study aims to identify the optimal method to recognize, risk stratify, and provide follow-up care for individuals at risk of hereditary cancer. The study team will conduct a Hybrid Type II comparative effectiveness-implementation trial, with a mixed methods component and process/formative evaluations for stakeholder engagement. The study team will evaluate three methods for identifying and risk-stratifying individuals at risk of hereditary cancer and providing post-risk stratification longitudinal care.

详细描述

The study team proposes a randomized, Hybrid Type II comparative effectiveness-implementation trial, with a mixed methods component and process/formative evaluations for stakeholder engagement. The study team will evaluate three methods for identifying and risk-stratifying individuals at risk of hereditary cancer and providing post-risk stratification longitudinal care.

Hypothesis

The study hypothesis is that Comparator 3 will identify more people at high risk of hereditary cancers and result in more screening behaviors, greater resource use, increased distress, higher perceived risk of cancer and higher satisfaction.

Long term objective: At study end, the study will show: 1) each comparator's strengths and weaknesses, 2) patient preferences, clinical outcomes, and compliance with each step from history collection to screening test completion, 3) the resources needed for each strategy, and 4) the contextual factors that impact their sustainability, dissemination and implementation. Study findings have high potential for generalizability because: 1) The multidisciplinary stakeholder team will help to minimize barriers to dissemination and implementation of the investigator's findings in other research settings; 2) Study results are independent of study setting; 3) The tested methods of family history assessment can occur remotely via paper or electronic interfaces; 4) The care coordination method has successful precedent in other disciplines and can be delivered remotely; 5) A process and formative evaluation with a diverse stakeholder team will inform sustainability, dissemination, and implementation, and result in an implementation guide; 6) The results will be relevant for both family history-based and direct-genetic testing strategies for population screening for hereditary cancer; 7) The results will inform population screening for any disease with hereditary risk.

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
25 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adult patients with ≥2 years of prior membership, ≥1 clinical visit in prior two years, and a listed email are eligible
  • •Patients must also have received healthcare services during the past 2 years at Kaiser Permanente Northern California (KPNC) sampling sites

排除标准

  • •Patients outside the targeted geographic area
  • •Patients who cannot speak or read English (given some survey instruments are validated only in English)
  • •Kaiser Permanente Northern California members in the no-contact database for research studies

研究组 & 干预措施

Comparator 1

Other

Participants will have their cancer risk assessed via usual care. Usual Care is defined as provider capture of family history during a clinical encounter and its entry into the electronic health record (EHR). Participants will take the a patient reported outcomes (PRO) survey once to assess participants experience, perspectives and thoughts on cancer, cancer risk, and cancer risk assessments.

干预措施: Usual care (Other)

Comparator 2

Experimental

Participants will have their cancer risk assessed using a short, standardized web-based questionnaire that will populate validated cancer risk models (such as Breast Cancer Risk Assessment Tool/Gail model 2, PREMM and/or MMRpro) which will take 5-10 minutes to complete. Following the cancer risk assessment, participants will be asked to take a PRO survey. PRO surveys will also be administered at the time of the cancer risk assessment and then 6 and 12 months following.

干预措施: online cancer risk assessment (Other)

Comparator 3

Experimental

Participants will have their cancer risk assessed using a more detailed, full version of the family history survey than the one comparator 2 participants take. This version is a full pedigree assessment, which entails family health history for all 1st, 2nd, and 3rd-degree relatives. Time needed for completion is 15-25 minutes, depending on family size and cancer risk. Participants will also be asked to take the PRO survey following the full cancer risk assessment and also at 6 and 12 months.

干预措施: online cancer risk assessment (Other)

结局指标

主要结局

Number of patients identified at high risk of cancer

时间窗: 0 to 12 months

Number of patients identified at high risk of cancer (cancer syndromes)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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