Breast CancerNCT04639934
Family History in a Singapore Oncology Population
An observational study of Breast Cancer, run by Duke University at 1 site in Singapore.
Trial summary
This study will create a Breast Cancer Clinical Decision Support Module in MeTree and validate and pilot the Breast Cancer Clinical Decision Support Module in a clinical setting within SingHealth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- MeTree
- How many people
- 102 participants
- Where
- 1 siteSingapore
- Study dates
- 7 Jan 2019to 31 Aug 2019
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: * New patients of the two intervention clinics (NCCS cancer genetics clinic and surgical breast cancer clinic) We will recruit 100 participants, of which 20 will be invited to participate in one to one interviews. * at least 10 employees in the above intervention clinics and the ongoing MeTree-Biobank pilot who are 1) staff assisting patients using MeTree, or 2) providers reviewing MeTree risk reports with patients. * 20 Healthy volunteers from the MeTree-Biobank pilot who have completed MeTree and agreed to re-contact for future studies, will be invited to participate in one to one interviews on the same topics as the patients in #1.
Who may be able to join
- New patients attending either of the two intervention clinics (NCCS cancer genetics clinic and surgical breast cancer clinic)
- Employees in the above intervention clinics and the ongoing MeTree-Biobank pilot who are 1) staff assisting patients using MeTree, or 2) providers reviewing MeTree risk reports with patients, will be invited to participate in one to one interviews. We plan to recruit at least 10 employees for interviews.
- Healthy volunteers from the MeTree-Biobank pilot who have completed MeTree and agreed to re-contact for future studies, will be invited to participate in one to one interviews on the same topics as the patients in #1. We will recruit 20 Biobank participants for interviews.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Clinical Implementation Pilot of an Oncology-specific Risk Assessment Tool in Singapore
This study will create a Breast Cancer Clinical Decision Support Module in MeTree and validate and pilot the Breast Cancer Clinical Decision Support Module in a clinical setting within SingHealth. This proposal leverages the larger collaborative work already started to explore clinically meaningful applications of MeTree within SingHealth. While MeTree has been shown to be clinically effective within primary care clinics in the U.S., SingHealth's oncologists are interested in leveraging MeTree's risk assessment features both to establish a more organized, standardized, and systematic process for collecting information to enhance cancer management and to maximize the advances in precision medicine for the benefit of cancer patients. Therefore, in collaboration with SingHealth oncologist Dr.Ngeow, the principal investigators propose to explore, develop, and pilot a prototype MeTree cancer module.
Read the detailed description
The value of precision medicine within clinical care is becoming increasingly more evident. Nowhere is this clearer than in the field of oncology. With recognition of the value of genetics in clinical care, the National Cancer Centre Singapore (NCCS) established a Cancer Genetics Service in 2006. This service performs a valuable function within NCCS by overseeing the care of patients found to have hereditary cancer syndromes and providing consultation to clinical oncologists on the appropriate, targeted role of genetic testing within cancer care. While the Cancer Genetics Service is available to all clinicians within NCCS, with the continually growing and evolving understanding of how genetics plays a role in cancer and cancer treatment, there are no clear, consistent guidelines on when to request consultation. This leads to both over- and underutilization of services with some patients being referred who do not require it and others being missed whose care would benefit from the expertise of a cancer geneticist.
In an effort to address these inconsistencies in care, the study team proposes to further develop and evaluate the implementation of a Duke-developed precision medicine software program, MeTree, within NCCS breast cancer clinics. MeTree is a patient-facing family history based risk assessment tool and clinical decision aid that was developed by researchers within Duke's Center for Applied Genomics and Precision Medicine (CAGPM). The initial intent of MeTree was to assist clinicians in identifying patients at greater than population risk based on a number of clinical and family health history (FHH) factors for a range of common conditions (including cancer) and provide clinical decision support (CDS) with specific recommendations based on common U.S. guidelines for prevention and screening.MeTree has been thoroughly tested and validated and is currently being implemented across five U.S. healthcare systems by way of a large cooperative grant through NHGRI's IGNITE network.2-7 Dr. Orlando is co-PI of this study and Dr. Wu served as a site PI.
Through the efforts of Drs. Wu and Orlando, among others, a research agreement was recently signed between Duke University and the National Heart Center Singapore (NHCS) to allow testing of MeTree within a cardiovascular epidemiologic study, the Biobank study (MeTree-Biobank pilot). The Biobank study is providing data to the SPECTRA healthy population database developed by the SingHealth/Duke-NUS Institute of Precision Medicine (PRISM). SPECTRA aims to collect detailed phenotypic and genomic information on 5,000 healthy Singaporeans. MeTree will be used to collect detailed FHH on Biobank participants. This collaboration is part of a larger partnership between CAGPM and PRISM to further develop cross-institution collaborations. Enrollment in the Biobank study is currently underway and incorporation of MeTree into the data capture flow started June 2017.
This proposal leverages the larger collaborative work already started to explore clinically meaningful applications of MeTree within SingHealth. While MeTree has been shown to be clinically effective within primary care clinics in the U.S., SingHealth's oncologists are interested in leveraging MeTree's risk assessment features both to establish a more organized, standardized, and systematic process for collecting information to enhance cancer management and to maximize the advances in precision medicine for the benefit of cancer patients. Therefore, in collaboration with SingHealth oncologist Dr. Ngeow, the principal investigators propose to explore, develop, and pilot a prototype MeTree cancer module through the following two aims:
Specific Aim 1: Create a Breast Cancer Clinical Decision Support Module in MeTree Specific Aim 2: Validate and Pilot the Breast Cancer Clinical Decision Support Module in a clinical setting within SingHealth.
APPROACH Specific Aim 1: Create a Breast Cancer Clinical Decision Support Module in MeTree. The prototype will focus on breast cancer, as a demonstration case, since the prevalence is high, the value of risk assessment is established, and MeTree already assesses risk for both familial and hereditary forms. To achieve this aim the investigators will work with Dr. Joanne Ngeow, head of the Cancer Genetics Service at NCCS, to understand current risk assessment practices in the oncology clinics, identify gaps and inefficiencies in meeting Singapore's risk assessment guidelines, and adapt MeTree to facilitate uptake of guideline-based care. All aspects of risk assessment will be evaluated, from gathering the right type of data to understanding the appropriate clinical actions that follow from each risk assessment result. The goals will be to: 1) create a MeTree integration plan for both patients and providers that will optimize its value, 2) incorporate additional data elements and risk algorithms into MeTree as appropriate, 3) generate tailored clinical decision support for the patient and their oncologist to facilitate appropriate ordering and interpretation of genetic tests. Drs. Wu, Orlando, and Ngeow will work together on all three steps, with Dr. Ngeow's expertise in genetics and oncology at SingHealth being critical for ensuring the team develops a useful and facile tool that meets the needs of SingHealth oncologists.
Deliverables These efforts will provide a breast cancer clinical decision support module that is ready for implementation testing in a breast cancer clinical environment. It will be a model upon which additional cancer CDS modules could be built, tested, and implemented.
Specific Aim 2: Validate and Pilot the Breast Cancer Clinical Decision Support Module in a clinical setting within SingHealth. To assess the feasibility and potential clinical utility of the Breast Cancer Clinical Decision Support Module, the investigators will perform a mixed-methods hybrid type II implementation-effectiveness pilot in the NCCS cancer genetics clinic and one additional surgical breast cancer clinic. The results of this 12-week pilot will inform both its potential impact on clinical care and how further to optimize it for broader clinical integration.
- Conditions
- Breast Cancer
- Being tested
- MeTree
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeTreeGenetic
Software program collecting family health history and generating clinical decision support for risk-based preventive care
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer patients | Breast cancer patients being seen at SingHealth Receives: Genetic: MeTree |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk Recommendations
measure rate of increased hereditary cancer risk found in breast cancer population
Measured: post-study, up to six months
Secondary outcomes (3)
Provider adherence to risk recommendations
measure provider actions in response to risk report (i.e. genetic counselling (GC) referrals ordered.)
Measured: post-study, up to six months
Participant adherence to risk recommendations
measure participant actions in response to genetic counselling referrals ordered (i.e GC completed)
Measured: post-study, up to six months
Participant satisfaction with using MeTree risk platform
measure patient satisfaction through post-MeTree survey
Measured: post-study, up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start7 Jan 2019
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
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 Breast CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lori A Orlando, MD MPH, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04639934
- Sponsor's protocol ID
- Pro00087654
- Status last verified
- Aug 2023
- First submitted
- 17 Nov 2020
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fung SM, Wu RR, Myers RA, Goh J, Ginsburg GS, Matchar D, Orlando LA, Ngeow J. Clinical implementation of an oncology-specific family health history risk assessment tool. Hered Cancer Clin Pract. 2021 Mar 20;19(1):20. doi: 10.1186/s13053-021-00177-y.
PubMed 33743786
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Clinical Implementation Pilot of an Oncology-specific Risk Assessment Tool in Singapore
- ClinicalTrials.gov ID
- NCT04639934
- Acronym / sponsor ID
- Pro00087654
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 23 Nov 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 create a Breast Cancer Clinical Decision Support Module in MeTree and validate and pilot the Breast Cancer Clinical Decision Support Module in a clinical setting within SingHealth. This proposal leverages the larger collaborative work already started to explore clinically meaningful applications of MeTree within SingHealth. While MeTree has been shown to be clinically effective within primary care clinics in the U.S., SingHealth's oncologists are interested in leveraging MeTree's risk assessment features both to establish a more organized, standardized, and systematic process for collecting information to enhance cancer management and to maximize the advances in precision medicine for the benefit of cancer patients. Therefore, in collaboration with SingHealth oncologist Dr.Ngeow, the principal investigators propose to explore, develop, and pilot a prototype MeTree cancer module.
Detailed description
The value of precision medicine within clinical care is becoming increasingly more evident. Nowhere is this clearer than in the field of oncology. With recognition of the value of genetics in clinical care, the National Cancer Centre Singapore (NCCS) established a Cancer Genetics Service in 2006. This service performs a valuable function within NCCS by overseeing the care of patients found to have hereditary cancer syndromes and providing consultation to clinical oncologists on the appropriate, targeted role of genetic testing within cancer care. While the Cancer Genetics Service is available to all clinicians within NCCS, with the continually growing and evolving understanding of how genetics plays a role in cancer and cancer treatment, there are no clear, consistent guidelines on when to request consultation. This leads to both over- and underutilization of services with some patients being referred who do not require it and others being missed whose care would benefit from the expertise of a cancer geneticist.
In an effort to address these inconsistencies in care, the study team proposes to further develop and evaluate the implementation of a Duke-developed precision medicine software program, MeTree, within NCCS breast cancer clinics. MeTree is a patient-facing family history based risk assessment tool and clinical decision aid that was developed by researchers within Duke's Center for Applied Genomics and Precision Medicine (CAGPM). The initial intent of MeTree was to assist clinicians in identifying patients at greater than population risk based on a number of clinical and family health history (FHH) factors for a range of common conditions (including cancer) and provide clinical decision support (CDS) with specific recommendations based on common U.S. guidelines for prevention and screening.MeTree has been thoroughly tested and validated and is currently being implemented across five U.S. healthcare systems by way of a large cooperative grant through NHGRI's IGNITE network.2-7 Dr. Orlando is co-PI of this study and Dr. Wu served as a site PI.
Through the efforts of Drs. Wu and Orlando, among others, a research agreement was recently signed between Duke University and the National Heart Center Singapore (NHCS) to allow testing of MeTree within a cardiovascular epidemiologic study, the Biobank study (MeTree-Biobank pilot). The Biobank study is providing data to the SPECTRA healthy population database developed by the SingHealth/Duke-NUS Institute of Precision Medicine (PRISM). SPECTRA aims to collect detailed phenotypic and genomic information on 5,000 healthy Singaporeans. MeTree will be used to collect detailed FHH on Biobank participants. This collaboration is part of a larger partnership between CAGPM and PRISM to further develop cross-institution collaborations. Enrollment in the Biobank study is currently underway and incorporation of MeTree into the data capture flow started June 2017.
This proposal leverages the larger collaborative work already started to explore clinically meaningful applications of MeTree within SingHealth. While MeTree has been shown to be clinically effective within primary care clinics in the U.S., SingHealth's oncologists are interested in leveraging MeTree's risk assessment features both to establish a more organized, standardized, and systematic process for collecting information to enhance cancer management and to maximize the advances in precision medicine for the benefit of cancer patients. Therefore, in collaboration with SingHealth oncologist Dr. Ngeow, the principal investigators propose to explore, develop, and pilot a prototype MeTree cancer module through the following two aims:
Specific Aim 1: Create a Breast Cancer Clinical Decision Support Module in MeTree Specific Aim 2: Validate and Pilot the Breast Cancer Clinical Decision Support Module in a clinical setting within SingHealth.
APPROACH Specific Aim 1: Create a Breast Cancer Clinical Decision Support Module in MeTree. The prototype will focus on breast cancer, as a demonstration case, since the prevalence is high, the value of risk assessment is established, and MeTree already assesses risk for both familial and hereditary forms. To achieve this aim the investigators will work with Dr. Joanne Ngeow, head of the Cancer Genetics Service at NCCS, to understand current risk assessment practices in the oncology clinics, identify gaps and inefficiencies in meeting Singapore's risk assessment guidelines, and adapt MeTree to facilitate uptake of guideline-based care. All aspects of risk assessment will be evaluated, from gathering the right type of data to understanding the appropriate clinical actions that follow from each risk assessment result. The goals will be to: 1) create a MeTree integration plan for both patients and providers that will optimize its value, 2) incorporate additional data elements and risk algorithms into MeTree as appropriate, 3) generate tailored clinical decision support for the patient and their oncologist to facilitate appropriate ordering and interpretation of genetic tests. Drs. Wu, Orlando, and Ngeow will work together on all three steps, with Dr. Ngeow's expertise in genetics and oncology at SingHealth being critical for ensuring the team develops a useful and facile tool that meets the needs of SingHealth oncologists.
Deliverables These efforts will provide a breast cancer clinical decision support module that is ready for implementation testing in a breast cancer clinical environment. It will be a model upon which additional cancer CDS modules could be built, tested, and implemented.
Specific Aim 2: Validate and Pilot the Breast Cancer Clinical Decision Support Module in a clinical setting within SingHealth. To assess the feasibility and potential clinical utility of the Breast Cancer Clinical Decision Support Module, the investigators will perform a mixed-methods hybrid type II implementation-effectiveness pilot in the NCCS cancer genetics clinic and one additional surgical breast cancer clinic. The results of this 12-week pilot will inform both its potential impact on clinical care and how further to optimize it for broader clinical integration.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer patients | – | Genetic: MeTreeBreast cancer patients being seen at SingHealth |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * New patients of the two intervention clinics (NCCS cancer genetics clinic and surgical breast cancer clinic) We will recruit 100 participants, of which 20 will be invited to participate in one to one interviews. * at least 10 employees in the above intervention clinics and the ongoing MeTree-Biobank pilot who are 1) staff assisting patients using MeTree, or 2) providers reviewing MeTree risk reports with patients. * 20 Healthy volunteers from the MeTree-Biobank pilot who have completed MeTree and agreed to re-contact for future studies, will be invited to participate in one to one interviews on the same topics as the patients in #1.
Key inclusion criteria (3 listed)
- New patients attending either of the two intervention clinics (NCCS cancer genetics clinic and surgical breast cancer clinic)
- Employees in the above intervention clinics and the ongoing MeTree-Biobank pilot who are 1) staff assisting patients using MeTree, or 2) providers reviewing MeTree risk reports with patients, will be invited to participate in one to one interviews. We plan to recruit at least 10 employees for interviews.
- Healthy volunteers from the MeTree-Biobank pilot who have completed MeTree and agreed to re-contact for future studies, will be invited to participate in one to one interviews on the same topics as the patients in #1. We will recruit 20 Biobank participants for interviews.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| MeTreeSoftware program collecting family health history and generating clinical decision support for risk-based preventive care | Genetic | Breast cancer patients |
Primary outcome
Risk Recommendations
Time frame: post-study, up to six months
measure rate of increased hereditary cancer risk found in breast cancer population
3 secondary outcomes
Provider adherence to risk recommendations
Time frame: post-study, up to six months
Participant adherence to risk recommendations
Time frame: post-study, up to six months
Participant satisfaction with using MeTree risk platform
Time frame: post-study, up to six months
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 10 Feb 2025.
- Derived from this study: PubMed 33743786Fung SM, Wu RR, Myers RA, Goh J, Ginsburg GS, Matchar D, Orlando LA, Ngeow J. Clinical implementation of an oncology-specific family health history risk assessment tool. Hered Cancer Clin Pract. 2021 Mar 20;19(1):20. doi: 10.1186/s13053-021-00177-y.
- 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.
Lori A Orlando, MD MPH principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Duke University at 1 site in Singapore.
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 3 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: finished, as of the sponsor's last update on 10 Feb 2025. 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 Singapore. 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?
Risk Recommendations (time frame: post-study, up to six months). 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 NCT04639934, 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 10 Feb 2025.