AzTrials
AzTrials

Breast CancerNCT04639934

Family History in a Singapore Oncology Population

An observational study of Breast Cancer, run by Duke University at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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.

Singapore1 site
  • NCCS Cancer Genetics Clinic

    Singapore

Other trials in Singapore

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 groups in NCT04639934
Study groupRoleWhat they receive
Breast cancer patientsBreast 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.

  1. Risk Recommendations

    measure rate of increased hereditary cancer risk found in breast cancer population

    Measured: post-study, up to six months

Secondary outcomes (3)
  1. 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

  2. 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

  3. 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.

  1. First posted23 Nov 2020
  2. Study start7 Jan 2019
  3. Primary completion31 Aug 2019
  4. Study completion31 Aug 2019

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in