Hereditary Cancer SyndromeTestMiGenesNCT05664867
Implementation of Population Cancer Genetic Services in Federally Qualified Health Centers (FQHC)
A study testing Mainstream Genetic Testing Model in people with Hereditary Cancer Syndrome, run by University of Illinois Chicago at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Hereditary Cancer Syndrome
- What is being tested?
- Mainstream Genetic Testing Model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provider or staff member at one of the 4 clinics participating in the clinical trial
- English speaking
Who cannot join
- Did not meet the inclusion criteria
- 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.
- Not a patient receiving care from the one of the clinics enrolled in the clincial trial
- Aim 2
- 1. Does not meet inclusion criteria above
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Illinois Cancer Center
Chicago, Illinois, 60612
Pamela Ganschow, MD, 312 413 9776, pgansch@uic.edu
Angelina Izguerra, BPH, 312 355 0567, adi5@uic.edu
About this study
Official title: Developing and Optimizing Best Practice Solutions for Implementation of Population Based Cancer Genetic Services in Federally Qualified Health Centers
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.
Read more
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.
Read the detailed description
More than 15 years after the release of evidence-based guidelines recommending hereditary cancer risk assessment and testing for at-risk individuals, fewer than one in five eligible patients receive this care. Utilization of cancer genetic services remains substantially lower among racial and ethnic minority populations. Addressing inequities in access to these services is essential, as approximately 10 to 15 percent of cancers are linked to inherited mutations, and early identification of high-risk individuals can support prevention and early detection strategies that reduce disparities in cancer outcomes.
Multiple social determinants of health (SDoH) contribute to limited access to genetic services among underserved populations. At the clinic level, many community health centers have limited capacity to systematically identify at-risk patients, employ few or no genetic specialists, and must rely on external systems for genetic counseling and testing. At the provider level, primary care clinicians often report low confidence and limited training in cancer genetics, while genetic specialists may have limited presence or integration in these care settings. At the patient level, structural, economic, and cultural barriers continue to restrict engagement in genetic testing and counseling.
This project will evaluate and compare two models of cancer genetic service delivery in primary care to improve equitable access among patients served by Federally Qualified Health Centers (FQHCs). The enhanced standard of care model (SOC+) uses universal electronic hereditary cancer risk assessment (HCRA) to identify eligible patients, combined with patient navigation to address individual barriers such as financial concerns and literacy needs. The mainstream genetic testing model (MGT) embeds genetic testing directly into primary care visits, allowing patients to receive education, counseling, and test ordering from their primary care provider without referral to specialty care.
Aim 1: Compare the effectiveness of MGT and SOC+ on uptake of genetic testing among minority patients receiving primary care within an urban FQHC system.
Aim 2: Evaluate implementation outcomes (acceptability, feasibility, and sustainability) and identify barriers and facilitators to cancer genetic service delivery in primary care using qualitative interviews with patients, providers, and clinic staff, guided by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework.
A quasi-experimental design will be used across four FQHC clinics, with each clinic assigned to one of the two models, two SOC+ and two MGT. Demographic and service utilization data, including referrals, testing completion, and time-to-test intervals, will be collected from the electronic medical record. Semi-structured interviews with patients, providers, and staff will further explore experiences and perceptions of each model.
This work will generate actionable evidence on scalable and sustainable approaches to delivering guideline-based genetic services in underserved primary care settings. Findings will inform best practices to reduce inequities in access to precision cancer prevention and early detection services.
- Conditions
- Hereditary Cancer Syndrome
- Being tested
- Mainstream Genetic Testing Model, Enhanced Standard of Care Model
- Medical subject headings
- Neoplastic Syndromes, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mainstream Genetic Testing ModelOther
Also called MGT
Mainstream Genetic Testing Model of Cancer Genetics Service Delivery
Enhanced Standard of Care ModelOther
Also called SOC+
Enhanced Standard of Care Model of Cancer Genetic Service Delivery
| Study group | Role | What they receive |
|---|---|---|
| MGT (Mainstream Genetic Testing) Model | Experimental | 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. Receives: Other: Mainstream Genetic Testing Model |
| SOC (Standard of Care) Model | Active comparator | 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. Receives: Other: Enhanced Standard of Care Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake of genetic testing
compare the uptake of genetic testing among patients in both models of cancer genetic delivery who screen positive on hereditary cancer risk asserssment (HCRA)
Measured: 2 years
Secondary outcomes (2)
Time to genetic testing
Time from screening positive on HCRA to genetic testing
Measured: 2 years
Evaluate the implementation outcomes (acceptability, feasibility and sustainability) and the barriers and facilitators of cancer genetic service delivery approaches within primary care at FQHCs
Qualitative interviews with patients and providers in the clinical trial, guided by the Explore, Prepare, Implement, Sustain (EPIS) implementation framework.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start1 Aug 2022
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hereditary Cancer SyndromeStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- clinical trial with a hybrid effectiveness-implementation quasi-experimental design
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pamela Ganschow, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05664867
- Sponsor's protocol ID
- 2022-1151
- Acronym
- TestMiGenes
- Status last verified
- Oct 2025
- First submitted
- 31 Oct 2022
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pan 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.
PubMed 42498079
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Optimizing Best Practice Solutions for Implementation of Population Based Cancer Genetic Services in Federally Qualified Health Centers
- ClinicalTrials.gov ID
- NCT05664867
- Acronym / sponsor ID
- TestMiGenes / 2022-1151
- Conditions
- Hereditary Cancer Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 27 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
More than 15 years after the release of evidence-based guidelines recommending hereditary cancer risk assessment and testing for at-risk individuals, fewer than one in five eligible patients receive this care. Utilization of cancer genetic services remains substantially lower among racial and ethnic minority populations. Addressing inequities in access to these services is essential, as approximately 10 to 15 percent of cancers are linked to inherited mutations, and early identification of high-risk individuals can support prevention and early detection strategies that reduce disparities in cancer outcomes.
Multiple social determinants of health (SDoH) contribute to limited access to genetic services among underserved populations. At the clinic level, many community health centers have limited capacity to systematically identify at-risk patients, employ few or no genetic specialists, and must rely on external systems for genetic counseling and testing. At the provider level, primary care clinicians often report low confidence and limited training in cancer genetics, while genetic specialists may have limited presence or integration in these care settings. At the patient level, structural, economic, and cultural barriers continue to restrict engagement in genetic testing and counseling.
This project will evaluate and compare two models of cancer genetic service delivery in primary care to improve equitable access among patients served by Federally Qualified Health Centers (FQHCs). The enhanced standard of care model (SOC+) uses universal electronic hereditary cancer risk assessment (HCRA) to identify eligible patients, combined with patient navigation to address individual barriers such as financial concerns and literacy needs. The mainstream genetic testing model (MGT) embeds genetic testing directly into primary care visits, allowing patients to receive education, counseling, and test ordering from their primary care provider without referral to specialty care.
Aim 1: Compare the effectiveness of MGT and SOC+ on uptake of genetic testing among minority patients receiving primary care within an urban FQHC system.
Aim 2: Evaluate implementation outcomes (acceptability, feasibility, and sustainability) and identify barriers and facilitators to cancer genetic service delivery in primary care using qualitative interviews with patients, providers, and clinic staff, guided by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework.
A quasi-experimental design will be used across four FQHC clinics, with each clinic assigned to one of the two models, two SOC+ and two MGT. Demographic and service utilization data, including referrals, testing completion, and time-to-test intervals, will be collected from the electronic medical record. Semi-structured interviews with patients, providers, and staff will further explore experiences and perceptions of each model.
This work will generate actionable evidence on scalable and sustainable approaches to delivering guideline-based genetic services in underserved primary care settings. Findings will inform best practices to reduce inequities in access to precision cancer prevention and early detection services.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- clinical trial with a hybrid effectiveness-implementation quasi-experimental design
| Arm | Type | Receives |
|---|---|---|
| MGT (Mainstream Genetic Testing) Model | Experimental | Other: Mainstream Genetic Testing ModelThe 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. |
| SOC (Standard of Care) Model | Active comparator | Other: Enhanced Standard of Care ModelThe 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. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Provider or staff member at one of the 4 clinics participating in the clinical trial
- English speaking
Key exclusion criteria (5 listed)
- Did not meet the inclusion criteria
- 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.
- Not a patient receiving care from the one of the clinics enrolled in the clincial trial
- Aim 2
- 1. Does not meet inclusion criteria above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mainstream Genetic Testing ModelAlso: MGTMainstream Genetic Testing Model of Cancer Genetics Service Delivery | Other | MGT (Mainstream Genetic Testing) Model |
| Enhanced Standard of Care ModelAlso: SOC+Enhanced Standard of Care Model of Cancer Genetic Service Delivery | Other | SOC (Standard of Care) Model |
Primary outcome
Uptake of genetic testing
Time frame: 2 years
compare the uptake of genetic testing among patients in both models of cancer genetic delivery who screen positive on hereditary cancer risk asserssment (HCRA)
2 secondary outcomes
Time to genetic testing
Time frame: 2 years
Evaluate the implementation outcomes (acceptability, feasibility and sustainability) and the barriers and facilitators of cancer genetic service delivery approaches within primary care at FQHCs
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Derived from this study: PubMed 42498079Pan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mainstream Genetic Testing Model in people with Hereditary Cancer Syndrome, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pamela Ganschow, MD (312-413-9776, pgansch@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uptake of genetic testing (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05664867, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.