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Family History Study on Cancer Risk

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ClinicalTrials.gov Identifier: NCT04145388
Recruitment Status : Recruiting
First Posted : October 30, 2019
Last Update Posted : August 13, 2020
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Kaiser Permanente

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.

Condition or disease Intervention/treatment Phase
Lynch Syndrome Colorectal Cancer Breast Cancer Ovarian Cancer Family Characteristics Genetic Predisposition Other: online cancer risk assessment Other: Usual care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Systems-Level Capture of Family History Data to Assess Risk of Cancer
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : March 31, 2024
Estimated Study Completion Date : August 31, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other: Usual care
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.
Other: online cancer risk assessment
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.
Other: online cancer risk assessment
Electronic surveys to collect family cancer history information.




Primary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04145388


Contacts
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Contact: Laura B Amsden, MSW, MPH 510-891-3870 laura.b.amsden@kp.org
Contact: Cecilia Doan, MPH 510-891-3710 cecilia.doan@kp.org

Locations
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United States, California
Division of Research, Kaiser Permanente Northern California Recruiting
Oakland, California, United States, 94612
Contact: Laura B Amsden, MSW, MPH    510-891-3870    laura.b.amsden@kp.org   
Contact: Cecilia Doan, MPH    510-891-3710    cecilia.doan@kp.org   
Sponsors and Collaborators
Kaiser Permanente
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Douglas Corley, MD, PhD Division of Research, Kaiser Permanente Northern California
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Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT04145388    
Other Study ID Numbers: 1407426
First Posted: October 30, 2019    Key Record Dates
Last Update Posted: August 13, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kaiser Permanente:
cancer
family characteristics
genetic predisposition
primary care
Additional relevant MeSH terms:
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Colorectal Neoplasms, Hereditary Nonpolyposis
Disease Susceptibility
Genetic Predisposition to Disease
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn
DNA Repair-Deficiency Disorders
Metabolic Diseases