- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04145388
Family History Study on Cancer Risk
Systems-Level Capture of Family History Data to Assess Risk of Cancer
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Laura B Amsden, MSW, MPH
- Phone Number: 510-891-3870
- Email: laura.b.amsden@kp.org
Study Contact Backup
- Name: Cecilia Doan, MPH
- Phone Number: 510-891-3710
- Email: cecilia.doan@kp.org
Study Locations
-
-
California
-
Oakland, California, United States, 94612
- Division of Research, Kaiser Permanente Northern California
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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.
|
Family cancer history captured by provider during a clinical encounter
|
Experimental: 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.
|
Electronic surveys to collect family cancer history information.
|
Experimental: 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.
|
Electronic surveys to collect family cancer history information.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients identified at high risk of cancer
Time Frame: 0 to 12 months
|
Number of patients identified at high risk of cancer (cancer syndromes)
|
0 to 12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Douglas Corley, MD, PhD, Division of Research, Kaiser Permanente Northern California
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Metabolic Diseases
- Neoplasms
- Neoplasms by Site
- Disease Attributes
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Genetic Diseases, Inborn
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Colorectal Neoplasms
- Neoplastic Syndromes, Hereditary
- DNA Repair-Deficiency Disorders
- Colorectal Neoplasms, Hereditary Nonpolyposis
- Disease Susceptibility
- Genetic Predisposition to Disease
Other Study ID Numbers
- 1407426
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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