NCT04639934

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 23, 2020

Completed
Last Updated

February 10, 2025

Status Verified

August 1, 2023

Enrollment Period

8 months

First QC Date

November 17, 2020

Last Update Submit

February 6, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Risk Recommendations

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

    post-study, up to six months

Secondary Outcomes (3)

  • Provider adherence to risk recommendations

    post-study, up to six months

  • Participant adherence to risk recommendations

    post-study, up to six months

  • Participant satisfaction with using MeTree risk platform

    post-study, up to six months

Study Arms (1)

Breast cancer patients

Breast cancer patients being seen at SingHealth

Genetic: MeTree

Interventions

MeTreeGENETIC

Software program collecting family health history and generating clinical decision support for risk-based preventive care

Breast cancer patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NCCS Cancer Genetics Clinic

Singapore, Singapore

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Lori A Orlando, MD MPH

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2020

First Posted

November 23, 2020

Study Start

January 7, 2019

Primary Completion

August 31, 2019

Study Completion

August 31, 2019

Last Updated

February 10, 2025

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations