Family History Study on Cancer Risk

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04145388
• Other study ID #: 1407426
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: August 31, 2025

Study information

• Verified date: February 2024
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 18623
• Est. completion date: August 31, 2025
• Est. primary completion date: March 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Breast Cancer
• Colorectal Cancer
• Colorectal Neoplasms, Hereditary Nonpolyposis
• Disease Susceptibility
• Family Characteristics
• Genetic Predisposition
• Genetic Predisposition to Disease
• Lynch Syndrome
• Ovarian Cancer

Intervention

Other:
• online cancer risk assessment
Electronic surveys to collect family cancer history information.
• Usual care
Family cancer history captured by provider during a clinical encounter

Locations

Country	Name	City	State
United States	Division of Research, Kaiser Permanente Northern California	Oakland	California

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients identified at high risk of cancer	Number of patients identified at high risk of cancer (cancer syndromes)	0 to 12 months