Cancer Health Assessments Reaching Many

NCT03426878 | Completed Results

• 1 other identifier: 2U01HG007292-05
• Study Type: interventional
• Target: 967
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Lynch syndrome; Hereditary breast and ovarian cancer

Outcome Measures

Primary Outcomes (1)

• Positive Findings for Hereditary Cancer Syndromes

  Number of people found to have a pathogenic (P) or likely pathogenic (LP) variant in one of the cancer genes associated with Lynch syndrome or hereditary breast and ovarian cancer

  For each person, the test result was available within approximately one month of the receipt of that person's specimen at the laboratory.

Secondary Outcomes (8)

• Positive Findings for Other Medically Actionable Genetic Conditions

  For each person, the test result was available within approximately one month of the receipt of that person's specimen at the laboratory.

• Positive Findings for a Selected List of Carrier Conditions

  For each person, the test result was available within approximately one month of the receipt of that person's specimen at the laboratory.

• Number of Participants With Healthcare Utilization Measured Via Electronic Medical Record (EMR) Data

  Within 12 months of participant receiving information about their hereditary cancer syndrome risk

• Participant Understanding of Recommended Care

  2 weeks post result disclosure, 6 months post result disclosure

• Participant Understanding of Genetic Test Results

  2 weeks post genetic result disclosure

Study Arms (2)

Traditional genetic counseling

ACTIVE COMPARATOR

This will be typical genetic counseling that a patient would receive in a traditional genetic counseling setting.

Other: Traditional genetic counseling

Modified genetic counseling

EXPERIMENTAL

This will be genetic counseling that is modified for a lower literacy patient and will include fewer technical terms and less complicated genetic information.

Other: Modified genetic counseling

Interventions

Modified genetic counseling OTHER

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.

Modified genetic counseling

Traditional genetic counseling OTHER

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.

Traditional genetic counseling

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Kaiser Permanente: lead
• National Human Genome Research Institute (NHGRI): collaborator
• University of Washington: collaborator
• Seattle Children's Hospital: collaborator
• University of California, San Francisco: collaborator
• Denver Health and Hospital Authority: collaborator
• Emory University: collaborator
• Dana-Farber Cancer Institute: collaborator
• Columbia University: collaborator

Study Sites (2)

Denver Health

Denver, Colorado, 80204, United States

Location

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227, United States

Location

Related Publications (3)

• Okuyama S, White LL, Anderson KP, Medina E, Deutsch S, Ransom C, Jackson P, Kauffman TL, Mittendorf KF, Leo MC, Bulkley JE, Wilfond BS, Goddard KA, Feigelson HS. Evaluating cancer genetic services in a safety net system: overcoming barriers for a lasting impact beyond the CHARM research project. J Community Genet. 2023 Jun;14(3):329-336. doi: 10.1007/s12687-023-00647-x. Epub 2023 May 1.

  PMID: 37126135 DERIVED

• Mittendorf KF, Lewis HS, Duenas DM, Eubanks DJ, Gilmore MJ, Goddard KAB, Joseph G, Kauffman TL, Kraft SA, Lindberg NM, Reyes AA, Shuster E, Syngal S, Ukaegbu C, Zepp JM, Wilfond BS, Porter KM. Literacy-adapted, electronic family history assessment for genetics referral in primary care: patient user insights from qualitative interviews. Hered Cancer Clin Pract. 2022 Jun 10;20(1):22. doi: 10.1186/s13053-022-00231-3.

  PMID: 35689290 DERIVED

• Mittendorf KF, Kauffman TL, Amendola LM, Anderson KP, Biesecker BB, Dorschner MO, Duenas DM, Eubanks DJ, Feigelson HS, Gilmore MJ, Hunter JE, Joseph G, Kraft SA, Lee SSJ, Leo MC, Liles EG, Lindberg NM, Muessig KR, Okuyama S, Porter KM, Riddle LS, Rolf BA, Rope AF, Zepp JM, Jarvik GP, Wilfond BS, Goddard KAB; CHARM study team. Cancer Health Assessments Reaching Many (CHARM): A clinical trial assessing a multimodal cancer genetics services delivery program and its impact on diverse populations. Contemp Clin Trials. 2021 Jul;106:106432. doi: 10.1016/j.cct.2021.106432. Epub 2021 May 11.

  PMID: 33984519 DERIVED

MeSH Terms

Conditions

Neoplastic Syndromes, Hereditary; Colorectal Neoplasms, Hereditary Nonpolyposis; Hereditary Breast and Ovarian Cancer Syndrome

Condition Hierarchy (Ancestors)

Neoplasms; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Breast Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine System Diseases; Gonadal Disorders

Results Point of Contact

• Title: Joanna Bulkley, PhD
• Organization: Kaiser Permanente Center for Health Research

joanna.e.bulkley@kpchr.org

5033352400

Study Officials

• Michael Leo, PhD

  Center for Health Research, Kaiser Permanente Northwest

  PRINCIPAL INVESTIGATOR

• Benjamin S Wilfond, MD

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participant will not know if they are receiving traditional or modified genetic counseling.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will receive exome sequencing. The randomization will be into one of two types of genetic counseling - traditional and modified.

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: February 8, 2018
• Study Start: August 15, 2018
• Primary Completion: August 20, 2020
• Study Completion: February 1, 2022
• Last Updated: September 11, 2025
• Results First Posted: September 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be loaded to ANVIL and ClinVar at least annually beginning in 2018.
• Access Criteria: Subject to ANVIL and ClinVar regulations.

Locations

US (2)