Clinical trial NCT04145388: Family History Study on Cancer Risk
Official title: Systems-Level Capture of Family History Data to Assess Risk of Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lynch Syndrome
Colorectal Cancer
Breast Cancer
Ovarian Cancer
Family Characteristics
Genetic Predisposition
Keywords: cancer
family characteristics
genetic predisposition
primary care
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2019-10-30
Enrollment: 18623
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients identified at high risk of cancer
timeFrame: 0 to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Division of Research, Kaiser Permanente Northern California
state: California
Study officials:
affiliation: Division of Research, Kaiser Permanente Northern California
name: Douglas Corley, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: