Cancer Health Assessments Reaching Many



Status:Recruiting
Healthy:No
Age Range:18 - 50
Updated:9/13/2018
Start Date:August 15, 2018
End Date:May 31, 2021
Contact:Tia L Kauffman, MPH
Email:tia.l.kauffman@kpchr.org
Phone:503-335-6792

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Exome Sequencing in Diverse Populations in Colorado & Oregon

The CHARM (Cancer Health Assessment Reaching Many) study will assess the utility of clinical
exome sequencing and how it affects care in diverse populations. The study population
includes adults at risk for hereditary cancer syndromes.

The primary objective is to implement a hereditary cancer risk assessment program in healthy
18-50 year-olds in primary care settings within a vertically integrated health delivery
system (Kaiser Permanente) and a federal qualified health center (Denver Health). The
investigators will assess clinical exome sequencing implementation and interpretation, as
well as tailored interactions for low health literacy including a contextualized consent
process, and a modified approach to results disclosure and genetic counseling. The
investigators will also assess the clinical utility (healthcare utilization and adherence to
recommended care) and personal utility of primary and additional results from clinical exome
sequencing, and evaluate the ethical and policy implications of considering personal utility
of genomic information decisions for health care coverage.

Aim 1. Implement a hereditary cancer risk-assessment program in healthy 18-50-year-old adults
in primary care settings, with stakeholder input, and offer exome sequencing to clarify risk.

Aim 1A. Identify and recruit 880 adult participants at-risk of a hereditary cancer syndrome.

Aim 1B: Generate medical exome sequence data and interpret variants. Aim 1C: Disclose
findings from medical exome sequencing, incorporate results into the electronic medical
record (EMR), and facilitate downstream patient management and coordination of care with the
provider.

Aim 1D. Engage stakeholders to tailor and optimize the program in diverse populations.

Aim 2. Evaluate and tailor for diverse populations the critical interactions in the program,
including the consent process, choices for reporting additional findings, and the response to
results disclosure.

Aim 2A. Design, implement, and assess a contextualized consent process to support informed
decision-making about participation in research about medical exome sequencing.

Aim 2B. Design, implement, and compare a novel decision aid in the second half of the study
for selecting the optional categories of additional findings with the approach we developed
in CSER1 that offered a category checklist.

Aim 2C. Design, implement, and compare a modified (communication-focused) approach to results
disclosure, genetic counseling, and decision making with a standard (information-focused)
approach.

Aim 3. Evaluate the clinical utility (including personal utility) and cost of using exome
sequencing to diagnose individuals with hereditary cancer syndromes and provide additional
findings.

Aim 3A: Measure the yield of reportable findings for hereditary cancer syndromes and
additional findings.

Aim 3B: Evaluate subsequent healthcare utilization for all study participants and adherence
to recommended care among individuals who are identified with a hereditary cancer syndrome in
diverse settings.

Aim 3C. Assess the personal utility of exome sequencing, including primary and additional
findings.

Aim 4. Address pragmatic and ethical challenges to the integration of genomic medicine into
clinical and health systems decision-making.

Aim 4A: Develop and pilot a system that integrates genomic, clinical, and healthcare
utilization data to inform clinicians and patients acting on genomic information and to
reduce care gaps in patient management.

Aim 4B: Advance the analysis of the ethical and policy implications of incorporating personal
utility of genomic information into the decision framework for healthcare coverage.

Inclusion Criteria:

- Kaiser Permanente Northwest or Denver Health patient

- Screens as high risk for a hereditary cancer syndrome via the risk assessment tool
algorithms OR have unknown family history on either their mother or father's side of
the family (or both)

- No known personal mutation that predisposes them to Lynch syndrome or hereditary
breast and ovarian cancer

- English or Spanish speaker

Exclusion Criteria:

- Known personal mutation

- Not an English or Spanish speaker

- Unable to provide informed consent

- Don't want results placed in their medical record
We found this trial at
2
sites
Portland, Oregon 97227
Principal Investigator: Katrina AB Goddard, PhD
Phone: 503-335-6353
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Portland, OR
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Denver, Colorado 80204
Principal Investigator: Katherine P Anderson, MD
Phone: 303-294-0896
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Denver, CO
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