Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
18623 participants
INTERVENTIONAL
2020-07-01
2025-08-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Comparator 1
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.
Usual care
Family cancer history captured by provider during a clinical encounter
Comparator 2
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.
online cancer risk assessment
Electronic surveys to collect family cancer history information.
Comparator 3
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.
online cancer risk assessment
Electronic surveys to collect family cancer history information.
Interventions
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online cancer risk assessment
Electronic surveys to collect family cancer history information.
Usual care
Family cancer history captured by provider during a clinical encounter
Eligibility Criteria
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Inclusion Criteria
* Patients must also have received healthcare services during the past 2 years at Kaiser Permanente Northern California (KPNC) sampling sites
Exclusion Criteria
* 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
25 Years
75 Years
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
Kaiser Permanente
OTHER
Responsible Party
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Principal Investigators
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Douglas Corley, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Division of Research, Kaiser Permanente Northern California
Locations
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Division of Research, Kaiser Permanente Northern California
Oakland, California, United States
Countries
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Other Identifiers
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1407426
Identifier Type: -
Identifier Source: org_study_id
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