Clinical trial · Interventional
Family History Study on Cancer Risk
Systems-Level Capture of Family History Data to Assess Risk of Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Family Characteristics | — | UNRESOLVED | — |
| Genetic Predisposition | — | UNRESOLVED | — |
| Lynch Syndrome | — | UNRESOLVED | — |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| online cancer risk assessment | Other | — | UNRESOLVED |
| Usual care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- OTHER
- label
- Comparator 1
- description
- 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.
- interventionNames
- Other: Usual care
- type
- EXPERIMENTAL
- label
- Comparator 2
- description
- 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.
- interventionNames
- Other: online cancer risk assessment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 25 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available