Cancer Health Assessments Reaching Many

Completed · Not applicable

Conditions studied: Hereditary Cancer Syndrome

In brief

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.

Key facts

Study ID

NCT03426878

Run by

Kaiser Permanente

People needed

967

Starts

2018-08-15

Expected to finish

2022-02-01

Last updated by the study team

2025-09-11

Who can join

Age: 18 and older, up to 49. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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 prior testing for familial mutations predisposing them to Lynch syndrome or hereditary breast and ovarian cancer
• English or Spanish speaker

You may not qualify if…

• Participant self-reported prior testing for Lynch syndrome (LS) or Hereditary Breast and Ovarian Cancer (HBOC) syndrome or identified as having previous comprehensive testing via Kaiser Permanente data files
• Not an English or Spanish speaker
• Unable to provide informed consent
• Don't want results placed in their medical record

Where it is running

• Denver Health — Denver, Colorado, United States
• Kaiser Permanente Center for Health Research — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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