Identifying and Caring for Individuals With Inherited Cancer Syndrome

Study Overview
=================
Brief Summary
-----------------
This trial examines approaches to identify and care for individuals with inherited cancer syndrome. The purpose of this study is to offer no cost genetic testing to the general public. Researchers hope to learn the value of providing broad, public-wide testing for high risk cancer types (like hereditary breast and ovarian cancer or Lynch syndromes) instead of only testing people whose families are known to be high risk.

Detailed Description
-----------------
PRIMARY OBJECTIVE: I. Evaluate the effectiveness and sustainability of heritable cancer syndrome testing in two proposed screening populations compared to current guidelines. SECONDARY OBJECTIVES: I. Measure adherence to current guidelines for screening and prophylactic intervention of Cohorts B and C compared to Cohort A to show non-inferiority. II. Measure the efficiency of cascade testing (defined as the ratio of family members screened over total possible) for Cohorts B and C compared to Cohort A to show non-inferiority. III. Determine the costs and effectiveness, specifically quality adjusted life years (QALYs) associated with genetic screening models based on Cohorts B and C to estimate incremental cost-effectiveness ratio (ICER) and show that the costs per QALY are below the acceptable cost effectiveness threshold. OUTLINE: Patients undergo collection of saliva samples for genetic testing. If genetic test is positive, patients receive genetic counseling. Patients also complete a survey about cancer prevention, screening, and treatment.

Official Title
-----------------
Approaches to Identify and Care for Individuals With Inherited Cancer Syndromes

Conditions
-----------------
BRCA1/2-Associated Hereditary Breast and Ovarian Cancer Syndrome, Breast Ductal Carcinoma In Situ, Hematopoietic and Lymphoid System Neoplasm, Hereditary Neoplastic Syndrome, Lynch Syndrome, Malignant Solid Neoplasm

Intervention / Treatment
-----------------
* Procedure: Biospecimen Collection
* Other: Genetic Counseling
* Other: Genetic Testing
* Other: Survey Administration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ALL COHORTS: 18 years of age or older Retrospective COHORT A: Per HIPAA waiver, Retrospective Cohort A will not actively consent Retrospective COHORT A: Patients may or may not be diagnosed with cancer Retrospective COHORT A: Patients have received genetic counseling in the past 5 years Retrospective COHORT A: Patients have genetic variants that include BRCA1, BRCA2 and/or Lynch syndrome COHORT A: Per Health Insurance Portability and Accountability Act (HIPAA) waiver, Cohort A returns survey as consent COHORT A: Patients may or may not be diagnosed with cancer COHORT A: Patients have received genetic counseling in the past 1 - 2 years COHORT A: Patients have genetic variants that include BRCA1, BRCA2 and/or Lynch syndrome COHORT A: INCLUSIVE of no contact list to exclude from Cohort B COHORT B: Creation of secure Medable account COHORT B: Consent to this project, either hard or electronic signature COHORT B: Consent to the Healthy Oregon Project (HOP) repository, either hard or electronic signature COHORT B: Choosing to submit a deoxyribonucleic acid (DNA) sample COHORT B: Patients diagnosed with any National Cancer Institute (NCI)-reportable cancers, including ductal carcinoma in situ (DCIS) and/or in situ breast cancer COHORT B: Must have had an encounter within past twelve months COHORT B: Exclude Cohort A COHORT C: Creation of secure Medable account COHORT C: Consent to this project, either hard or electronic signature COHORT C: Consent to the HOP repository, either hard or electronic signature COHORT C: Choosing to submit a DNA sample

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Screening (genetic testing)<br>Patients undergo collection of saliva samples for genetic testing. If genetic test is positive, patients receive genetic counseling. | Procedure: Biospecimen Collection<br>* Undergo collection of saliva sample<br>* Other names: Biological Sample Collection;Other: Genetic Counseling<br>* Receive genetic counseling if testing results are positive<br>Other: Genetic Testing<br>* Undergo genetic testing<br>* Other names: Genetic Test;Other: Survey Administration<br>* Complete a survey<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness and sustainability of heritable cancer syndrome testing in the two novel testing populations | Determine the costs and effectiveness, specifically Quality Adjusted Life Years (QALYs) associated with genetic screening models based on Cohorts B and C to estimate incremental cost-effectiveness ratio (ICER) and show that the costs per QALY are below the acceptable cost effectiveness threshold. | Up to 5 years | 
| Adherence to standard of care for hereditary breast and ovarian cancer (HBOC) and Lynch syndromes | For Lynch syndrome we identify compliance as colonoscopy in past two years and bilateral salpingo-oophorectomy (BSO ) after child-bearing age. For HBOC, compliance is defined as breast imaging in past year or risk reducing surgery at any point in women. | Up to 5 years | 
| Merged risk reduction strategies of bilateral salpingo-oophorectomy (BSO) or bilateral mastectomy and imaging | The merged risk reduction strategies of BSO or bilateral mastectomy and the imaging are treated as evidence of risk reducing behavior. | Up to 5 years | 
| Cascade screening rate among Lynch or HBOC positive carriers | Will conduct negative binomial regression model and non-inferiority will be determined by rate ratio and its 95% confidence interval (CI). | Up to 5 years |