Cancer, BreastFHAMeNCT04726319
Family History App in Personalized Medicine
A study testing FHAMe Intervention in people with Cancer, Breast and Cancer, Ovarian, run by University of Toronto at 1 site in Canada.
Trial summary
A complete family history (FH) may identify persons at high risk for certain conditions. They can be offered genetic testing and life-saving screening and treatment. In practice, complete FH is rarely collected or entered into the electronic medical record (EMR). Read more about this study
- Who is it for?
- Ages 30 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer, Breast, Cancer, Ovarian, Cancer, Colorectal
- What is being tested?
- FHAMe Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 627 participants
- Where
- 1 siteCanada
- Study dates
- 20 Sep 2021to 27 Jan 2026
- 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 30 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 30-69 years of age
Who cannot join
- Pregnancy
- Must be patients of staff physicians (i.e. no resident patients)
- Must have email address registered in the OCEAN system
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Family History App in Personalized Medicine (FHAMe): A Pilot Randomized Controlled Trial
A complete family history (FH) may identify persons at high risk for certain conditions. They can be offered genetic testing and life-saving screening and treatment. In practice, complete FH is rarely collected or entered into the electronic medical record (EMR). The Family History Screening Questionnaire is a survey patients complete to tell whether they are at increased risk of specific cancers, heart disease or diabetes. We will test a new way to record FH that includes an app to improve use of FH by family physicians and patients. The strategy includes education for patients and physicians about the importance of FH; patient completion of the FH questionnaire prior to appointments; and prompts in the EMR. We expect this to help family physicians and patients interpret FH and make the best decisions. We will assess the proportion of patients with new EMR FH information. We will explore if the strategy increases appropriate referrals for screening and genetic consultation for those at increased FH risk. We will also obtain patients' and physicians' feedback on this strategy. This new approach may improve FH information exchange between patients and physicians, encourage shared decision-making and reduce cancer deaths and chronic disease burden.
Read the detailed description
Family history (FH) is one of the cornerstones of medicine, and provides a glimpse of the genetic make-up of a family. Family physicians (FPs) are in an ideal position to identify those at risk of harboring a genetic mutation requiring further genetics assessment. A challenge in the family medicine clinic is obtaining an adequate FH to triage appropriate patients for further assessment and management. Patients with an identified germline mutation have a variety of therapeutic options including prophylactic surgeries and high risk screening for hereditary cancer syndromes, cardiac devices for inherited cardiac conditions, and intensive statin therapy for those with hypercholesterolemia, all of which can be potentially life-saving.
A systematic review showed that the application of systematic tools which enable information gathering, improves FH accuracy and completeness. Patient-completed FH questionnaires are gaining attention with evidence of reasonable completeness and accuracy. However, challenges have been reported in incorporating these tools including uploading FH results into the EMR and into management strategies.
To address the challenge of obtaining an adequate FH and triaging appropriate patients for further assessment and possibly life-saving interventions, we propose to use a simple FH questionnaire, the "Family History Screening Questionnaire", which will be filled out by patients electronically with the results integrated into the EMR to identify families at risk of inherited diseases.
Overarching Research Objectives:
- To evaluate an innovative strategy to collect family history (FH) and improve personalized primary care. Strategies include: a novel Family History Screening questionnaire (FHSQ) (app), provider alerts, seamless integration into the electronic medical record (EMR), electronic clinical decision support through point-of-care tools, and patient and provider education
- Primary objective: to determine if this innovative strategy will increase the proportion of intervention patients that have updated documentation of family history in the EMR.
- Secondary objective: to describe contextual factors that may influence implementation of this family history strategy into primary care. To explore whether the intervention led to increased discussion about FH and resulted in more personalized screening/management.
This study will determine if increasing awareness of the importance of FH and facilitating collection through a novel FH app with physician alerts, integration into the EMR, electronic decision support and resources, is associated with: increased collection of FH in the EMR, FH discussion by patients and clinicians and personalized, risk appropriate screening/management. Development and implementation of this novel FH app and strategy have the potential to improve FH information exchange between patients and primary care providers, facilitate shared decision-making about personalized screening and management based on FH risk, reduce cancer deaths and chronic disease burden and build the foundation for personalized medicine.
- Conditions
- Cancer, Breast, Cancer, Ovarian, Cancer, Colorectal, Cancer, Prostate, Melanoma, Coronary Artery Disease
- Being tested
- FHAMe Intervention
- Keywords
- Family history, Family medicine, Genetics, Personalized medicine
- Medical subject headings
- Breast Neoplasms, Ovarian Neoplasms, Colorectal Neoplasms, Prostatic Neoplasms, Melanoma, Coronary Artery Disease, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FHAMe InterventionOther
Patients will receive an invitation email prior to their scheduled clinical visit which includes information about the study, a link to the YouTube patient presentation, and a link to the consent form and questionnaire. Patients will be invited to fill out the questionnaire prior to their appointment. After patients complete the initial questionnaire, physicians will receive an EMR message on the day of patient's clinic visit alerting them that patient family history information is available and to complete the Family History Action Form. They will be prompted to respond to the message which will open the action form and ask what action the provider intends to take with this family history information. The form will then link to management support tools for use during the patient visit. All participants will attend their clinical visit after which they will receive a post-visit electronic survey regarding their clinical visit and whether family history was reviewed with their provider.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | In addition to usual care, patients will be asked to answer questions about any family history through the use of a questionnaire. Receives: Other: FHAMe Intervention |
| Usual Care | No intervention | Patients receive usual care, which consists of health care providers inquiring about and dealing with family history as they would in usual practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with new documentation of family history in EMR
The proportion of patients with new documentation of family history in the EMR within 30 days after the visit, compared to patients in control group practices
Measured: 30 days post visit
Positive family history documentation
The proportion of patients in the intervention arm with positive documented family history in the EMR, compared to patients in control group practices
Measured: 30 days post visit
Proportion of patients in each study arm with new documentation of family history in EMR
The proportion of patients with new documentation of family history in the EMR for each study arm as a whole, over the full 6-month period of the study
Measured: 6 months
Proportion of patients, for each consenting clinician, with new documentation of family history in EMR
The proportion of patients with new documentation of family history in the EMR for each consenting clinician, 6 months prior to the intervention and 6 months after
Measured: 1 year
Family history of breast/ovarian/colorectal/prostate cancer
Proportion of patients with documented family history of cancer in the EMR measured through the number of 1st degree relatives
Measured: 30 days post visit
Changes in risk-appropriate screening based on family history
Through the use of UTOPIAN data which is routinely collected and qualitative interviews with family physicians using semi-structured interview guides, we will explore whether the FH strategy enables risk-appropriate screening based on FH, and referral of patients at high FH risk to genetics
Measured: 30 days post visit
Secondary outcomes (4)
Recruitment rate
Rate of practice and participant recruitment during the intervention period
Measured: 6 months
Participation rate
Proportion of patients completing the questionnaire, and providers attending the webinar, reviewing family history, using clinical tools, and having family history discussions with patients
Measured: 6 months
Usage of family history information
Exploring how family history was obtained and used by patients and physicians through questionnaires and qualitative interviews
Measured: 30 days
Attitudes towards the FHAMe intervention
Exploring patient and team experiences and attitudes to the innovation through questionnaires and qualitative interviews
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start20 Sep 2021
- Primary completion30 Jun 2022
- Study completion27 Jan 2026
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 Cancer, BreastStudies of the same condition, open and under way.
- More trials run by University of TorontoThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Matched-paired randomized control trial
- Masking
- None (open label)
- Enrolment
- 627 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, June Carroll, University of Toronto
- Investigators
- June Carroll, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04726319
- Sponsor's protocol ID
- 20-0270-E
- Acronym
- FHAMe
- Status last verified
- May 2026
- First submitted
- 22 Jan 2021
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carroll JC, Greiver M, Kukan S, Bearss E, Walji S, Moineddin R, Aliarzadeh B, Kalia S, Allanson J, Grunfeld E, Gupta K, Heisey R, Kavanagh D, Kim R, Levy M, Morrison S, Muraca M, Mutasingwa D, O'Brien MA, Permaul J, Sullivan F, Wilson B. An Innovative Strategy for Collecting Family Health History: An Effectiveness-Implementation Trial in Primary Care Clinics. Ann Fam Med. 2025 Sep 22;23(5):399-406. doi: 10.1370/afm.240472.
PubMed 40983547
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family History App in Personalized Medicine (FHAMe): A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04726319
- Acronym / sponsor ID
- FHAMe / 20-0270-E
- Conditions
- Cancer, Breast, Cancer, Ovarian, Cancer, Colorectal, Cancer, Prostate, Melanoma, Coronary Artery Disease
- Keywords
- Family history, Family medicine, Genetics, Personalized medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 627 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 27 Jan 2026 (actual)
- First posted
- 27 Jan 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.
A complete family history (FH) may identify persons at high risk for certain conditions. They can be offered genetic testing and life-saving screening and treatment. In practice, complete FH is rarely collected or entered into the electronic medical record (EMR). The Family History Screening Questionnaire is a survey patients complete to tell whether they are at increased risk of specific cancers, heart disease or diabetes. We will test a new way to record FH that includes an app to improve use of FH by family physicians and patients. The strategy includes education for patients and physicians about the importance of FH; patient completion of the FH questionnaire prior to appointments; and prompts in the EMR. We expect this to help family physicians and patients interpret FH and make the best decisions. We will assess the proportion of patients with new EMR FH information. We will explore if the strategy increases appropriate referrals for screening and genetic consultation for those at increased FH risk. We will also obtain patients' and physicians' feedback on this strategy. This new approach may improve FH information exchange between patients and physicians, encourage shared decision-making and reduce cancer deaths and chronic disease burden.
Detailed description
Family history (FH) is one of the cornerstones of medicine, and provides a glimpse of the genetic make-up of a family. Family physicians (FPs) are in an ideal position to identify those at risk of harboring a genetic mutation requiring further genetics assessment. A challenge in the family medicine clinic is obtaining an adequate FH to triage appropriate patients for further assessment and management. Patients with an identified germline mutation have a variety of therapeutic options including prophylactic surgeries and high risk screening for hereditary cancer syndromes, cardiac devices for inherited cardiac conditions, and intensive statin therapy for those with hypercholesterolemia, all of which can be potentially life-saving.
A systematic review showed that the application of systematic tools which enable information gathering, improves FH accuracy and completeness. Patient-completed FH questionnaires are gaining attention with evidence of reasonable completeness and accuracy. However, challenges have been reported in incorporating these tools including uploading FH results into the EMR and into management strategies.
To address the challenge of obtaining an adequate FH and triaging appropriate patients for further assessment and possibly life-saving interventions, we propose to use a simple FH questionnaire, the "Family History Screening Questionnaire", which will be filled out by patients electronically with the results integrated into the EMR to identify families at risk of inherited diseases.
Overarching Research Objectives:
- To evaluate an innovative strategy to collect family history (FH) and improve personalized primary care. Strategies include: a novel Family History Screening questionnaire (FHSQ) (app), provider alerts, seamless integration into the electronic medical record (EMR), electronic clinical decision support through point-of-care tools, and patient and provider education
- Primary objective: to determine if this innovative strategy will increase the proportion of intervention patients that have updated documentation of family history in the EMR.
- Secondary objective: to describe contextual factors that may influence implementation of this family history strategy into primary care. To explore whether the intervention led to increased discussion about FH and resulted in more personalized screening/management.
This study will determine if increasing awareness of the importance of FH and facilitating collection through a novel FH app with physician alerts, integration into the EMR, electronic decision support and resources, is associated with: increased collection of FH in the EMR, FH discussion by patients and clinicians and personalized, risk appropriate screening/management. Development and implementation of this novel FH app and strategy have the potential to improve FH information exchange between patients and primary care providers, facilitate shared decision-making about personalized screening and management based on FH risk, reduce cancer deaths and chronic disease burden and build the foundation for personalized medicine.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Matched-paired randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: FHAMe InterventionIn addition to usual care, patients will be asked to answer questions about any family history through the use of a questionnaire. |
| Usual Care | No intervention | –Patients receive usual care, which consists of health care providers inquiring about and dealing with family history as they would in usual practice. |
Who may qualify
- Ages
- 30 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 30-69 years of age
Key exclusion criteria (3 listed)
- Pregnancy
- Must be patients of staff physicians (i.e. no resident patients)
- Must have email address registered in the OCEAN system
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 |
|---|---|---|
| FHAMe InterventionPatients will receive an invitation email prior to their scheduled clinical visit which includes information about the study, a link to the YouTube patient presentation, and a link to the consent form and questionnaire. Patients will be invited to fill out the questionnaire prior to their appointment. After patients complete the initial questionnaire, physicians will receive an EMR message on the day of patient's clinic visit alerting them that patient family history information is available and to complete the Family History Action Form. They will be prompted to respond to the message which will open the action form and ask what action the provider intends to take with this family history information. The form will then link to management support tools for use during the patient visit. All participants will attend their clinical visit after which they will receive a post-visit electronic survey regarding their clinical visit and whether family history was reviewed with their provider. | Other | Intervention |
Primary outcome
Proportion of patients with new documentation of family history in EMR
Time frame: 30 days post visit
The proportion of patients with new documentation of family history in the EMR within 30 days after the visit, compared to patients in control group practices
Positive family history documentation
Time frame: 30 days post visit
The proportion of patients in the intervention arm with positive documented family history in the EMR, compared to patients in control group practices
Proportion of patients in each study arm with new documentation of family history in EMR
Time frame: 6 months
The proportion of patients with new documentation of family history in the EMR for each study arm as a whole, over the full 6-month period of the study
Proportion of patients, for each consenting clinician, with new documentation of family history in EMR
Time frame: 1 year
The proportion of patients with new documentation of family history in the EMR for each consenting clinician, 6 months prior to the intervention and 6 months after
Family history of breast/ovarian/colorectal/prostate cancer
Time frame: 30 days post visit
Proportion of patients with documented family history of cancer in the EMR measured through the number of 1st degree relatives
Changes in risk-appropriate screening based on family history
Time frame: 30 days post visit
Through the use of UTOPIAN data which is routinely collected and qualitative interviews with family physicians using semi-structured interview guides, we will explore whether the FH strategy enables risk-appropriate screening based on FH, and referral of patients at high FH risk to genetics
4 secondary outcomes
Recruitment rate
Time frame: 6 months
Participation rate
Time frame: 6 months
Usage of family history information
Time frame: 30 days
Attitudes towards the FHAMe intervention
Time frame: 30 days
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 6 May 2026.
- Derived from this study: PubMed 40983547Carroll JC, Greiver M, Kukan S, Bearss E, Walji S, Moineddin R, Aliarzadeh B, Kalia S, Allanson J, Grunfeld E, Gupta K, Heisey R, Kavanagh D, Kim R, Levy M, Morrison S, Muraca M, Mutasingwa D, O'Brien MA, Permaul J, Sullivan F, Wilson B. An Innovative Strategy for Collecting Family Health History: An Effectiveness-Implementation Trial in Primary Care Clinics. Ann Fam Med. 2025 Sep 22;23(5):399-406. doi: 10.1370/afm.240472.
- 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.
June Carroll, MD principal investigator
MOUNT SINAI HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FHAMe Intervention in people with Cancer, Breast and Cancer, Ovarian, run by University of Toronto at 1 site in Canada.
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 6 May 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 Canada. 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 patients with new documentation of family history in EMR (time frame: 30 days post visit). The study lists 6 primary outcomes in all. 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 NCT04726319, 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 6 May 2026.