Breast Cancer, Colorectal Cancer, Family Characteristics, Genetic Predisposition, Lynch Syndrome, Ovarian Cancer
Conditions
Keywords
cancer, family characteristics, genetic predisposition, primary care
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.
Interventions
OTHERonline cancer risk assessment
Electronic surveys to collect family cancer history information.
OTHERUsual care
Family cancer history captured by provider during a clinical encounter
Sponsors
Patient-Centered Outcomes Research Institute
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients identified at high risk of cancer | 0 to 12 months | Number of patients identified at high risk of cancer (cancer syndromes) |
Countries
United States
Outcome results
None listed