NCT04145388

Family History Study on Cancer Risk

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 18,623 (actual)
• Sponsor: Kaiser Permanente · Academic / Other
• Sex: All
• Age: 25 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Lynch Syndrome
• Colorectal Cancer
• Breast Cancer
• Ovarian Cancer
• Family Characteristics
• Genetic Predisposition

Interventions

Type	Name	Description
OTHER	online cancer risk assessment	Electronic surveys to collect family cancer history information.
OTHER	Usual care	Family cancer history captured by provider during a clinical encounter

Timeline

• Start date: 2020-07-01
• Primary completion: 2023-03-15
• Completion: 2025-08-31
• First posted: 2019-10-30
• Last updated: 2024-02-14

Locations

1 site across 1 country: United States