Clinical trial · Interventional
Implementation of Population Cancer Genetic Services in Federally Qualified Health Centers (FQHC)
Developing and Optimizing Best Practice Solutions for Implementation of Population Based Cancer Genetic Services in Federally Qualified Health Centers
- 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 goal of this clinical trial is for researchers to compare the effectiveness of a mainstreamed model of genetic testing (MGT) with an enhanced standard of care model (SOC+) on the uptake of genetic testing among at-risk patients in an urban Federally Qualified Health Center (primary care) setting using a hybrid-effectiveness study design. Aim 1 is to compare the effectiveness of MGT and SOC+ interventions on the uptake of genetic testing among patients receiving primary care in an urban federally qualified health center (FQHC) system using a randomized trial study design. The hypothesis is that the uptake of testing will be higher among patients receiving services through the MGT compared with the SOC+ model. Aim 2 is to evaluate the implementation outcomes (acceptability, feasibility and sustainability) and the barriers and facilitators of cancer genetic service delivery approaches within primary care at FQHCs via qualitative interviews with patients, primary care providers and clinic staff, and organizational leaders, guided by the Explore, Prepare, Implement, Sustain (EPIS) implementation framework. The study will take place at four community health clinics that are part of a Federally Qualified Health Center (FQHC) network in Chicago. Each clinic will use one of two ways of providing cancer genetic services: an enhanced standard of care model that includes patient navigation support (SOC+), or a mainstream genetic testing model (MGT) in which primary care providers offer testing directly. Information such as patients' demographic characteristics, referrals for genetic counseling, completion of genetic testing, and how long it takes to complete testing will be collected from clinic records. Patients, healthcare providers, and clinic staff will also be invited to take part in interviews to share their experiences and perspectives on how each model worked in practice.
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 |
|---|---|---|---|
| Enhanced Standard of Care Model | Other | — | UNRESOLVED |
| Mainstream Genetic Testing Model | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- MGT (Mainstream Genetic Testing) Model
- description
- The mainstream genetic testing (MGT) model of cancer genetic services involves a non-genetics healthcare provider, such as the primary care provider, who engages patients in the counseling, consenting, and ordering of genetic testing. The provider/care team discloses the genetic test results and refers patients for genetic counseling only when genetic test results are abnormal. By eliminating the pre- and post-test counseling visits with a genetics provider, the MGT model has the potential to provide scalable access to genetic services.
- interventionNames
- Other: Mainstream Genetic Testing Model
- type
- ACTIVE_COMPARATOR
- label
- SOC (Standard of Care) Model
- description
- The enhanced standard of care model (SOC+) is the current referral model of cancer genetic services delivery with an enhancement to include screening for and resources to address health literacy. This model begins with a health care provider's recognition, identification and then referral of a patient to a genetic counselor where genetic testing takes place if appropriate. This model is time- and resource- intensive and may not be scalable.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 25 Years
Show eligibility criteria text
Aim 1 and 2 Inclusion Criteria for patients 1. Adults age 25+ 2. English speaking 3. Identified as eligible for cancer genetic testing for a hereditary breast or colon cancer syndrome (e.g., BRCA, Lynch or familial polyposis syndrome) as defined by NCCN criteria45-46 4. Screened positive and agreed to have study staff contact them in the future to participate in virtual/telephone interviews about their experiences with cancer genetics services. 5. Patient receiving care from one of the 4 Federally Qualified Health Center clinics enrolled in the clinical trial Exclusion Criteria: 1. Did not meet the inclusion criteria 2. Did not screen positive on HCRA and/ or did not agree to have study staff contact them in the future to participate in virtual/telephone interviews about their experiences with cancer genetics services. 3. Not a patient receiving care from the one of the clinics enrolled in the clincial trial Aim 2 Inclusion Criteria for Providers/Staff: 1. Provider or staff member at one of the 4 clinics participating in the clinical trial 2. English speaking Exclusion Criteria: 1\. Does not meet inclusion criteria above
References
Publications (1)
- DERIVEDPan V, Wang C, Bobitt J, Izguerra A, Kim S, Molina Y, Stackhouse N, Rauscher GH, Ganschow P. TestMiGenes: A hybrid effectiveness-implementation mixed methods study evaluating cancer genetic service delivery models in primary care at a federally qualified health center. Contemp Clin Trials. 2026 Sep;168:108414. doi: 10.1016/j.cct.2026.108414. Epub 2026 Jul 24. PMID 42498079