Clinical trial · Interventional
Cancer Health Assessments Reaching Many
Exome Sequencing in Diverse Populations in Colorado & Oregon
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hereditary Cancer Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Modified genetic counseling | Other | — | UNRESOLVED |
| Traditional genetic counseling | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Traditional genetic counseling
- description
- This will be typical genetic counseling that a patient would receive in a traditional genetic counseling setting.
- interventionNames
- Other: Traditional genetic counseling
- type
- EXPERIMENTAL
- label
- Modified genetic counseling
- description
- This will be genetic counseling that is modified for a lower literacy patient and will include fewer technical terms and less complicated genetic information.
- interventionNames
- Other: Modified genetic counseling
Primary outcomes (1)
- measure
- Positive Findings for Hereditary Cancer Syndromes
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 49 Years
Show eligibility criteria text
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 prior testing for familial mutations predisposing them to Lynch syndrome or hereditary breast and ovarian cancer * English or Spanish speaker Exclusion Criteria: * 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
References
Publications (3)
- DERIVEDOkuyama 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
- DERIVEDMittendorf 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
- DERIVEDMittendorf 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