Cancer Health Assessments Reaching Many

Summary

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 18-49 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.

Conditions

• Hereditary Cancer Syndrome

Interventions

OTHER

Modified genetic counseling

After participants at high risk for a hereditary cancer syndrome receive exome sequencing, they will receive modified genetic counseling to help them understand the results.

OTHER

Traditional genetic counseling

After participants at high risk for a hereditary cancer syndrome receive exome sequencing, they will receive traditional genetic counseling to help them understand the results.

Sponsors & Collaborators

• National Human Genome Research Institute (NHGRI)

  collaborator NIH

• University of Washington

  collaborator OTHER

• Seattle Children's Hospital

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• Denver Health and Hospital Authority

  collaborator OTHER

• Emory University

  collaborator OTHER

• Dana-Farber Cancer Institute

  collaborator OTHER

• Columbia University

  collaborator OTHER

• Kaiser Permanente

  lead OTHER

Principal Investigators

• Michael Leo, PhD · Center for Health Research, Kaiser Permanente Northwest

• Benjamin S Wilfond, MD · Seattle Children's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

49 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-08-15

Primary Completion

2020-08-20

Completion

2022-02-01

Countries

• United States

Study Locations