Hereditary Cancer-Predisposing SyndromeNCT04510896
Inherited Risk Evaluation Tool (InheRET): Identifying Patients at Increased Risk for Hereditary Disease
A study testing InheRET, Patient Acceptance and Physician Acceptance Survey in people with Hereditary Cancer-Predisposing Syndrome, run by InheRET, Inc at 4 sites in United States.
Trial summary
This study will evaluate the impact InheRET™, an online family history gathering and risk assessment reporting tool, has on facilitating National Comprehensive Cancer Network(NCCN) guideline compliant referrals for cancer genetic counseling/genetic evaluation by decreasing and/or removing the barriers of 1)… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hereditary Cancer-Predisposing Syndrome
- What is being tested?
- InheRET, Patient Acceptance and Physician Acceptance Survey
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,232 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Sep 2020to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Primary Care sites:Adult patients with New and Health Maintenance Exam appointments at participating clinics
- Genetics sites: Adult patients with new referrals for genetic counseling
Who cannot join
- Patients who were previously referred or who have an appointment for genetic counseling pending.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
InheRET, Inc.
Ann Arbor, Michigan, 48109
Michigan Medicine
Ann Arbor, Michigan, 48109
Hamilton Community Health Network - withdrew from study
Flint, Michigan, 48505
Ascension St. Mary's Hospital - withdrew from study
Saginaw, Michigan, 48604
About this study
Official title: InheRET: A Software-as-a-Service (SaaS) Solution to Identifying Patients at Increased Risk for Hereditary Disease
This study will evaluate the impact InheRET™, an online family history gathering and risk assessment reporting tool, has on facilitating National Comprehensive Cancer Network(NCCN) guideline compliant referrals for cancer genetic counseling/genetic evaluation by decreasing and/or removing the barriers of 1) time-consuming in-clinic 3-generation family history collection, and 2) interpretation of the family and personal history in light of current NCCN guidelines.
Identifying individuals at increased risk for cancer has been shown to decrease morbidity and mortality in multiple clinical settings. Investigators hypothesize that InheRET will prove to be accurate, efficient, and accessible, and that its use will improve identification of individuals at risk for inherited susceptibility to cancer. The investigators propose also that using this tool will result in a reduction of inappropriate genetic counseling referrals and reduce unnecessary genetic testing in both primary and specialty care settings. InheRET will allow health care providers to focus resources on individuals at higher risk for developing cancer.
Read the detailed description
This study will evaluate the impact InheRET™, an online family history gathering and risk assessment reporting tool, has on facilitating National Comprehensive Cancer Network(NCCN) guideline compliant referrals for cancer genetic counseling/genetic evaluation by decreasing and/or removing the barriers of 1) time-consuming in-clinic 3-generation family history collection, and 2) interpretation of the family and personal history in light of current NCCN guidelines.
This is a prospective study with a pre/post intervention analysis. The prior 6-months' genetic counseling referrals to Michigan Medicine will be collected for each site to serve as baseline data and compared to the intervention data to measure the difference made by InheRET utilization. Primary care sites are selected to offer the broadest range of patient populations to ensure the InheRET tool works well in diverse groups accessing varied clinical settings. The Cancer Genetics and MM Breast and Ovarian Cancer Risk Evaluation Clinics will allow us to measure the appropriateness of referrals and the impact of InheRET on genetic counseling workflows as patients from the primary care sites are referred for counseling from throughout the tri-state catchment areas and beyond. Similarly, investigators will review electronic health records for appropriateness of referrals to other counseling clinics at Michigan Medicine.
This will be accomplished by implementing InheRET in a variety of clinical settings to measure its acceptance by providers and patients as well as any changes made in referral patterns as a result of its use, compared to patterns of referral before it is implemented. Patients completing the InheRET online tool form will be followed longitudinally by surveys to discover their risk management actions (i.e. genetic counseling appointment, genetic testing, screenings, prophylaxis) and the reasons for or against undertaking such actions. Providers will also be surveyed to determine the impact InheRET has made to their workflow, the acceptability of this tool by their practice, and the usefulness of InheRET's features to accomplish its goals. This study has a goal enrollment of 2109 patients in Phase I (already enrolled) and at least 1023 patient subjects in Phase II (anticipated) to use the InheRET program for the purpose of this study and will also enroll six to twelve (6-12) physicians to obtain reflection on experience using InheRET for the purpose of this study.
- Conditions
- Hereditary Cancer-Predisposing Syndrome
- Being tested
- InheRET, Patient Acceptance, Physician Acceptance Survey
- 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.
InheRETOther
Also called InheRET 2.0 - Phase I, InheRET 3.0 - Phase II
Primary Appropriate Referral Rates 6-months pre-intervention vs post-intervention Compare appropriate genetic counseling referral rates (as defined by NCCN guidelines) per patient (across all sites) in the pre-intervention vs post- intervention period. Only referrals to Michigan Medicine genetics clinics will be included in the statistical analysis. Having access to MM health records, we will be able to assess the appropriateness of the referrals.
Patient AcceptanceOther
Acceptance by Patients Over the course of the study Acceptance measures will include completion rates and levels of ease of use of InheRET by the patient. Impact measures will include uptake of advised risk management interventions. We will qualitatively describe why patients do not follow up with their referral. We will explore patterns of acceptance and impact levels by demographic and clinical data using correlation, t- tests, ANOVA, or their non-parametric equivalents.
Physician Acceptance SurveyOther
Secondary Acceptance by Physicians Over the course of the study Acceptance by physicians will measure the physician effort required to deploy and use InheRET in their respective clinics, and overall satisfaction. Impact measures will include appropriate referral rates and rates of genetic testing. We will qualitatively describe why patients are not referred for genetic counseling if indicated. We will explore patterns in acceptance and impact levels by demographic and clinical data using correlations, t-tests, ANOVA, or their non-parametric equivalents.
| Study group | Role | What they receive |
|---|---|---|
| Pre-InheRET | No intervention | Determine appropriate genetic counseling referral rates (as defined by NCCN guidelines) per patient (across all sites) in the pre-intervention 6-month period. Only referrals to Michigan Medicine (MM) genetics clinics will be included in the statistical analysis. Having access to MM health records, we will be able to assess the appropriateness of the referrals. |
| Post-InheRET | Experimental | Determine appropriate genetic counseling referral rates (as defined by NCCN guidelines) per patient (across all sites) in the post-intervention period. Only referrals to Michigan Medicine genetics clinics will be included in the statistical analysis. Having access to MM health records, we will be able to assess the appropriateness of the referrals. Receives: Other: InheRET; Other: Patient Acceptance; Other: Physician Acceptance Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre- and Post-Rate of Referrals of Patients to Genetic Counseling from Primary Care Clinics,
Average number of patients per month referred to genetic counseling before and after InheRET's implementation in clinic.
Measured: 6 months prior to InheRET as compared to post implementation.
Secondary outcomes (3)
Physician Acceptance and Impact
Physicians will be consented and surveyed to determine acceptance, utility, and impact on clinical workflows. For discrete data elements, data will be reported as the number of physicians out of "n" responses. Qualitative data will be anonymized as needed, grouped thematically and reported. Responses from the two surveys will be compared to determine if perceptions have changed over time. Data will be reported as above with a % change added for discrete data elements.
Measured: Physicians will be surveyed within 3 months and again upon completion of enrollment, approximately 1 year.
Patient Acceptance of InheRET
Acceptance measures will include InheRET program completion rates (%) and levels of ease of use of InheRET by the patient, via survey at completion of the form. Patients will rank, using a 5-point Likert Scale, Ease of Use, and Understandability. Yes/No answers with comments will collect data on Cancer Coverage, Increased Knowledge of Family History, and Problems Encountered.
Investigators will explore patterns of acceptance levels by demographic and clinical data using correlation, t- tests, ANOVA, or their non-parametric equivalents.
Measured: Immediately upon completion of the personal and family health history form.
Qualitative Impact on Patients
Impact measures will include uptake of advised risk management interventions (genetic counseling, testing, screening, lifestyle changes, therapeutics, and prophylaxis), collected by survey and through medical record exam. Investigators will also qualitatively describe why patients do not follow up with their referral, gathered through a survey sent 12 months after completion (Phase I) and every 6 months x 3 (Phase II). We will explore patterns of impact levels by demographic and clinical data using correlation, t- tests, ANOVA, or their non-parametric equivalents.
Measured: Follow up surveys 12- to 18-months following completion of the InheRET program.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start1 Sep 2020
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary Cancer-Predisposing SyndromeStudies of the same condition, open and under way.
- 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
- Parallel groups
- Model description
- Each patient is requested to take the InheRET personal and family health history form. If consented patients fail to complete the form within one week of consenting, they may receive up to three (3) weekly reminder emails. The survey will take less than 10 minutes for low-risk patients. Completion time for higher risk patients depends on the size of the family, the number of conditions to report, and the patient's skill level with completing online forms. The InheRET form can be completed from any web-enabled device at the patient's convenience. Follow-up surveys will be sent as follows: 1. Consented participants fail to complete the InheRET health history for 2 months after consent to determine reason(s) for not completing. 2. Consented participants who complete the InheRET health history - 6 and 12 months after completion to identify actions taken since completion including genetic counseling, genetic testing, screening, lifestyle changes, and prophylaxis.
- Masking
- None (open label)
- Enrolment
- 2,232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InheRET, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Michigan
- Responsible party
- Sponsor
- Investigators
- David Keren, MD, Principal investigator, InheRET, IncElena Stoffel, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04510896
- Sponsor's protocol ID
- 1R41CA239842-01
- Status last verified
- Jul 2021
- First submitted
- 6 Aug 2020
- Last updated
- 30 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this time, we do not plan to make individual participant data available for other researchers. Consolidated data will be available.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- InheRET: A Software-as-a-Service (SaaS) Solution to Identifying Patients at Increased Risk for Hereditary Disease
- ClinicalTrials.gov ID
- NCT04510896
- Acronym / sponsor ID
- 1R41CA239842-01
- Conditions
- Hereditary Cancer-Predisposing Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,232 participants (estimated)
- Lead sponsor
- InheRET, IncIndustry (pharma, biotech, devices)
- Collaborators
- University of Michigan
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 12 Aug 2020 (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.
This study will evaluate the impact InheRET™, an online family history gathering and risk assessment reporting tool, has on facilitating National Comprehensive Cancer Network(NCCN) guideline compliant referrals for cancer genetic counseling/genetic evaluation by decreasing and/or removing the barriers of 1) time-consuming in-clinic 3-generation family history collection, and 2) interpretation of the family and personal history in light of current NCCN guidelines.
Identifying individuals at increased risk for cancer has been shown to decrease morbidity and mortality in multiple clinical settings. Investigators hypothesize that InheRET will prove to be accurate, efficient, and accessible, and that its use will improve identification of individuals at risk for inherited susceptibility to cancer. The investigators propose also that using this tool will result in a reduction of inappropriate genetic counseling referrals and reduce unnecessary genetic testing in both primary and specialty care settings. InheRET will allow health care providers to focus resources on individuals at higher risk for developing cancer.
Detailed description
This study will evaluate the impact InheRET™, an online family history gathering and risk assessment reporting tool, has on facilitating National Comprehensive Cancer Network(NCCN) guideline compliant referrals for cancer genetic counseling/genetic evaluation by decreasing and/or removing the barriers of 1) time-consuming in-clinic 3-generation family history collection, and 2) interpretation of the family and personal history in light of current NCCN guidelines.
This is a prospective study with a pre/post intervention analysis. The prior 6-months' genetic counseling referrals to Michigan Medicine will be collected for each site to serve as baseline data and compared to the intervention data to measure the difference made by InheRET utilization. Primary care sites are selected to offer the broadest range of patient populations to ensure the InheRET tool works well in diverse groups accessing varied clinical settings. The Cancer Genetics and MM Breast and Ovarian Cancer Risk Evaluation Clinics will allow us to measure the appropriateness of referrals and the impact of InheRET on genetic counseling workflows as patients from the primary care sites are referred for counseling from throughout the tri-state catchment areas and beyond. Similarly, investigators will review electronic health records for appropriateness of referrals to other counseling clinics at Michigan Medicine.
This will be accomplished by implementing InheRET in a variety of clinical settings to measure its acceptance by providers and patients as well as any changes made in referral patterns as a result of its use, compared to patterns of referral before it is implemented. Patients completing the InheRET online tool form will be followed longitudinally by surveys to discover their risk management actions (i.e. genetic counseling appointment, genetic testing, screenings, prophylaxis) and the reasons for or against undertaking such actions. Providers will also be surveyed to determine the impact InheRET has made to their workflow, the acceptability of this tool by their practice, and the usefulness of InheRET's features to accomplish its goals. This study has a goal enrollment of 2109 patients in Phase I (already enrolled) and at least 1023 patient subjects in Phase II (anticipated) to use the InheRET program for the purpose of this study and will also enroll six to twelve (6-12) physicians to obtain reflection on experience using InheRET for the purpose of this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each patient is requested to take the InheRET personal and family health history form. If consented patients fail to complete the form within one week of consenting, they may receive up to three (3) weekly reminder emails. The survey will take less than 10 minutes for low-risk patients. Completion time for higher risk patients depends on the size of the family, the number of conditions to report, and the patient's skill level with completing online forms. The InheRET form can be completed from any web-enabled device at the patient's convenience. Follow-up surveys will be sent as follows: 1. Consented participants fail to complete the InheRET health history for 2 months after consent to determine reason(s) for not completing. 2. Consented participants who complete the InheRET health history - 6 and 12 months after completion to identify actions taken since completion including genetic counseling, genetic testing, screening, lifestyle changes, and prophylaxis.
| Arm | Type | Receives |
|---|---|---|
| Pre-InheRET | No intervention | –Determine appropriate genetic counseling referral rates (as defined by NCCN guidelines) per patient (across all sites) in the pre-intervention 6-month period. Only referrals to Michigan Medicine (MM) genetics clinics will be included in the statistical analysis. Having access to MM health records, we will be able to assess the appropriateness of the referrals. |
| Post-InheRET | Experimental | Other: InheRET, Other: Patient Acceptance, Other: Physician Acceptance SurveyDetermine appropriate genetic counseling referral rates (as defined by NCCN guidelines) per patient (across all sites) in the post-intervention period. Only referrals to Michigan Medicine genetics clinics will be included in the statistical analysis. Having access to MM health records, we will be able to assess the appropriateness of the referrals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Primary Care sites:Adult patients with New and Health Maintenance Exam appointments at participating clinics
- Genetics sites: Adult patients with new referrals for genetic counseling
Key exclusion criteria (1 listed)
- Patients who were previously referred or who have an appointment for genetic counseling pending.
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 |
|---|---|---|
| InheRETAlso: InheRET 2.0 - Phase I, InheRET 3.0 - Phase IIPrimary Appropriate Referral Rates 6-months pre-intervention vs post-intervention Compare appropriate genetic counseling referral rates (as defined by NCCN guidelines) per patient (across all sites) in the pre-intervention vs post- intervention period. Only referrals to Michigan Medicine genetics clinics will be included in the statistical analysis. Having access to MM health records, we will be able to assess the appropriateness of the referrals. | Other | Post-InheRET |
| Patient AcceptanceAcceptance by Patients Over the course of the study Acceptance measures will include completion rates and levels of ease of use of InheRET by the patient. Impact measures will include uptake of advised risk management interventions. We will qualitatively describe why patients do not follow up with their referral. We will explore patterns of acceptance and impact levels by demographic and clinical data using correlation, t- tests, ANOVA, or their non-parametric equivalents. | Other | Post-InheRET |
| Physician Acceptance SurveySecondary Acceptance by Physicians Over the course of the study Acceptance by physicians will measure the physician effort required to deploy and use InheRET in their respective clinics, and overall satisfaction. Impact measures will include appropriate referral rates and rates of genetic testing. We will qualitatively describe why patients are not referred for genetic counseling if indicated. We will explore patterns in acceptance and impact levels by demographic and clinical data using correlations, t-tests, ANOVA, or their non-parametric equivalents. | Other | Post-InheRET |
Primary outcome
Pre- and Post-Rate of Referrals of Patients to Genetic Counseling from Primary Care Clinics,
Time frame: 6 months prior to InheRET as compared to post implementation.
Average number of patients per month referred to genetic counseling before and after InheRET's implementation in clinic.
3 secondary outcomes
Physician Acceptance and Impact
Time frame: Physicians will be surveyed within 3 months and again upon completion of enrollment, approximately 1 year.
Patient Acceptance of InheRET
Time frame: Immediately upon completion of the personal and family health history form.
Qualitative Impact on Patients
Time frame: Follow up surveys 12- to 18-months following completion of the InheRET program.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2021.
- Individual participant dataSharing planned: No. At this time, we do not plan to make individual participant data available for other researchers. Consolidated data will be available.
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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. This study is not recruiting at the moment.
David Keren, MD principal investigator
InheRET, Inc
Elena Stoffel, MD principal investigator
University of Michigan
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing InheRET, Patient Acceptance and Physician Acceptance Survey in people with Hereditary Cancer-Predisposing Syndrome, run by InheRET, Inc at 4 sites 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 1 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: status not confirmed, as of the sponsor's last update on 30 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre- and Post-Rate of Referrals of Patients to Genetic Counseling from Primary Care Clinics, (time frame: 6 months prior to InheRET as compared to post implementation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2021; AzTrials last refreshed its copy on 6 Nov 2026.