Gynecologic CancerProgenyNCT04890327
Web-based Family History Tool
A study testing Web-based family health history tool in people with Gynecologic Cancer and Breast Cancer, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The purpose of this pilot study is to determine if a web-based tool that collects family health history is useful for patients being seen in a gynecologic oncology office setting. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gynecologic Cancer, Breast Cancer, BRCA1 Mutation
- What is being tested?
- Web-based family health history tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2019to 31 Dec 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 to 100 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female > 18 years of age. Scheduled for new patient visit with one of the gynecologic oncologists at Weill Cornell Medicine (Melissa Frey MD, Kevin Holcomb MD, Evelyn Cantillo MD, Eloise Chapman MD).
Who cannot join
- Subjects who cannot communicate in English as the FHH collection tool and surveys are available only in English.
- Subjects who were adopted and have no information about their family health history.
- Subjects who do not present for the new patient visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Utility of a Web-based Tool for Collection of Family Health History and Risk-assessment in Patients Presenting to a Gynecologic Oncology Clinic
The purpose of this pilot study is to determine if a web-based tool that collects family health history is useful for patients being seen in a gynecologic oncology office setting. This research study is being done because collecting a comprehensive family health history is critical as it allows physicians to appropriately refer patients for genetic counseling and genetic testing. However, prior research indicates that the family health history collected in clinical settings is often inadequate to truly assess the risk of genetic disease. Therefore we plan to explore a web-based program that guides patients through the collection of their family health history and uses this information to create clear concise pedigrees (family tree information) and risk assessment models that can be used by a physician during the office visit.
Read the detailed description
Patients presenting for a new patient visit with a gynecologic oncologist will be randomized to one of three methods of collection of family health history (Arm 1 - standard of care consisting of interview with the physician; Arm 2 - completion of a web-based family health history tool completed in the clinic waiting room on a computer; Arm 3 - completion of a web-based family health history tool completed prior to the visit and accessed by an email link). A new 4th arm was added with 200 chart reviews to retrospectively look back at how previous family health history was taken for new patients in 2019. The study will evaluate the quality of the family health history collected, the resulting referral to genetic services and patient and physician satisfaction.
- Conditions
- Gynecologic Cancer, Breast Cancer, BRCA1 Mutation, BRCA2 Mutation
- Being tested
- Web-based family health history tool
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based family health history toolOther
Web-based tool that collects subject's family health history through a series of questions and generates a pedigree which documents a risk assessment report for the physician to use. The risk assessment report uses standard, validated risk scores including GAIL , CLAUS, BRCAPRO which measure breast cancer risk, and MMRPRO which measures endometrial cancer risk, MELAPRO which measures melanoma cancer risk, and PANCPRO which measures pancreatic cancer risk
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Patient presents to new Gynecologic Oncology appointment, family health history is collected by the physician during the clinic visit. Both the subject and physician complete assessment survey at the completion of clinic visit. Subject's medical record reviewed 6 months following study enrollment to determine subject's diagnosis, whether or not subject underwent genetic counseling and/or genetic testing and review genetic testing results. |
| Office | Experimental | Patient presents to new Gynecologic Oncology appointment, subject is given access to a desk top computer in office and instructed to complete web-based family health history tool. Physician reviews results of patients web-based family health history tool.Subject and physician complete assessment survey at the completion of clinic visit. Subject's medical record reviewed 6 months following study enrollment to determine subject's diagnosis, whether or not subject underwent genetic counseling and/or genetic testing and review genetic testing results. Receives: Other: Web-based family health history tool |
| Home | Experimental | Patient is emailed a link containing web-based family health history tool prior to presenting for new Gynecologic Oncology appointment. Physician reviews results of patients web-based family health history tool. Subject and physician complete assessment survey at the completion of clinic visit. Subject's medical record reviewed 6 months following study enrollment to determine subject's diagnosis, whether or not subject underwent genetic counseling and/or genetic testing and review genetic testing results. Receives: Other: Web-based family health history tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with high quality family health history (FHH)
To compare the amount of subjects with a high quality family health history in each of the study arms that properly assesses disease risk. Currently FHH in a gynecologic oncology clinic setting is inadequate to assess disease risk. The use of a web-based FHH collection tool that also offers the providers with a risk assessment tool may address these challenges and increase the comprehensiveness of FHH collection and risk assessment in the gynecologic oncology clinic.
For a pedigree to be considered high quality, at least one individual in the pedigree must meet all quality criteria ("high quality relative").
- Three generations of relatives
- Relatives' lineage (e.g. paternal or maternal side)
- Relatives' gender
- An up-to-date FHH
- Pertinent negatives in FHH noted (i.e. no FHH of cancer)
- Age of disease onset in affected relatives
- For deceased relatives - the age of death
- For deceased relatives - the cause of death.
Measured: Anytime between 18 - 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start9 Sep 2019
- Primary completion15 Sep 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancerStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melissa Frey, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04890327
- Sponsor's protocol ID
- 1612017795
- Acronym
- Progeny
- Status last verified
- Feb 2023
- First submitted
- 13 May 2021
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Utility of a Web-based Tool for Collection of Family Health History and Risk-assessment in Patients Presenting to a Gynecologic Oncology Clinic
- ClinicalTrials.gov ID
- NCT04890327
- Acronym / sponsor ID
- Progeny / 1612017795
- Conditions
- Gynecologic Cancer, Breast Cancer, BRCA1 Mutation, BRCA2 Mutation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 18 May 2021 (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 purpose of this pilot study is to determine if a web-based tool that collects family health history is useful for patients being seen in a gynecologic oncology office setting. This research study is being done because collecting a comprehensive family health history is critical as it allows physicians to appropriately refer patients for genetic counseling and genetic testing. However, prior research indicates that the family health history collected in clinical settings is often inadequate to truly assess the risk of genetic disease. Therefore we plan to explore a web-based program that guides patients through the collection of their family health history and uses this information to create clear concise pedigrees (family tree information) and risk assessment models that can be used by a physician during the office visit.
Detailed description
Patients presenting for a new patient visit with a gynecologic oncologist will be randomized to one of three methods of collection of family health history (Arm 1 - standard of care consisting of interview with the physician; Arm 2 - completion of a web-based family health history tool completed in the clinic waiting room on a computer; Arm 3 - completion of a web-based family health history tool completed prior to the visit and accessed by an email link). A new 4th arm was added with 200 chart reviews to retrospectively look back at how previous family health history was taken for new patients in 2019. The study will evaluate the quality of the family health history collected, the resulting referral to genetic services and patient and physician satisfaction.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Patient presents to new Gynecologic Oncology appointment, family health history is collected by the physician during the clinic visit. Both the subject and physician complete assessment survey at the completion of clinic visit. Subject's medical record reviewed 6 months following study enrollment to determine subject's diagnosis, whether or not subject underwent genetic counseling and/or genetic testing and review genetic testing results. |
| Office | Experimental | Other: Web-based family health history toolPatient presents to new Gynecologic Oncology appointment, subject is given access to a desk top computer in office and instructed to complete web-based family health history tool. Physician reviews results of patients web-based family health history tool.Subject and physician complete assessment survey at the completion of clinic visit. Subject's medical record reviewed 6 months following study enrollment to determine subject's diagnosis, whether or not subject underwent genetic counseling and/or genetic testing and review genetic testing results. |
| Home | Experimental | Other: Web-based family health history toolPatient is emailed a link containing web-based family health history tool prior to presenting for new Gynecologic Oncology appointment. Physician reviews results of patients web-based family health history tool. Subject and physician complete assessment survey at the completion of clinic visit. Subject's medical record reviewed 6 months following study enrollment to determine subject's diagnosis, whether or not subject underwent genetic counseling and/or genetic testing and review genetic testing results. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Female > 18 years of age. Scheduled for new patient visit with one of the gynecologic oncologists at Weill Cornell Medicine (Melissa Frey MD, Kevin Holcomb MD, Evelyn Cantillo MD, Eloise Chapman MD).
Key exclusion criteria (3 listed)
- Subjects who cannot communicate in English as the FHH collection tool and surveys are available only in English.
- Subjects who were adopted and have no information about their family health history.
- Subjects who do not present for the new patient visit.
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 |
|---|---|---|
| Web-based family health history toolWeb-based tool that collects subject's family health history through a series of questions and generates a pedigree which documents a risk assessment report for the physician to use. The risk assessment report uses standard, validated risk scores including GAIL , CLAUS, BRCAPRO which measure breast cancer risk, and MMRPRO which measures endometrial cancer risk, MELAPRO which measures melanoma cancer risk, and PANCPRO which measures pancreatic cancer risk | Other | Home, Office |
Primary outcome
Proportion of subjects with high quality family health history (FHH)
Time frame: Anytime between 18 - 24 months
To compare the amount of subjects with a high quality family health history in each of the study arms that properly assesses disease risk. Currently FHH in a gynecologic oncology clinic setting is inadequate to assess disease risk. The use of a web-based FHH collection tool that also offers the providers with a risk assessment tool may address these challenges and increase the comprehensiveness of FHH collection and risk assessment in the gynecologic oncology clinic. For a pedigree to be considered high quality, at least one individual in the pedigree must meet all quality criteria ("high quality relative"). 1. Three generations of relatives 2. Relatives' lineage (e.g. paternal or maternal side) 3. Relatives' gender 4. An up-to-date FHH 5. Pertinent negatives in FHH noted (i.e. no FHH of cancer) 6. Age of disease onset in affected relatives 7. For deceased relatives - the age of death 8. For deceased relatives - the cause of death.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Melissa Frey, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based family health history tool in people with Gynecologic Cancer and Breast Cancer, run by Weill Medical College of Cornell University 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 1 Mar 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of subjects with high quality family health history (FHH) (time frame: Anytime between 18 - 24 months). 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 1 Mar 2023.