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Spots Global Cancer Trial Database for Family History Study on Cancer Risk

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Trial Identification

Brief Title: Family History Study on Cancer Risk

Official Title: Systems-Level Capture of Family History Data to Assess Risk of Cancer

Study ID: NCT04145388

Study Description

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

Minimum Age: 25 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Division of Research, Kaiser Permanente Northern California, Oakland, California, United States

Contact Details

Name: Douglas Corley, MD, PhD

Affiliation: Division of Research, Kaiser Permanente Northern California

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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