The Perspective of Healthy Individuals on Breast Cancer Risk Prediction Report In The Indonesian Population (PERCEPTION)

November 10, 2023 updated by: Nalagenetics Pte Ltd

The Perspective of Healthy Individuals on Breast Cancer Risk Prediction Report in The Indonesian Population (Perspektif Para Individu Sehat Terhadap Laporan Prediksi Risiko Kanker Payudara)

In 2016, a meta-analysis showed that DNA-based risk reporting alone does not facilitate behavior change. However, there have been several studies showing that tailoring care plans related to diet may help with adherence to a tailored diet plan.

Risk prediction report displays both Polygenic Risk Score (PRS) and modifiable (non-genetic) risk factors. Overtime, the investigators aim to combine both PRS and modifiable risk factors to have a localized and stronger prediction model for the local population. The risk prediction report is designed to tailor care plans for patients by their physicians or care planner.

Focus groups allow deeper discussions in themes important to guide design of the report. This method has been used in previous similar studies, such as one by Cutting et al to understand physicians' preference in integrating genetic reports into daily practice. Studies also have shown that local adoption of personalized medicine and care is hindered by limited infrastructure of information management and awareness, despite personalized medicine being widely adopted in healthcare systems in developing countries.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta, DKI Jakarta, Indonesia, 12930
        • MRCCC Siloam Hospitals Semanggi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Female
  2. Able to give informed consent
  3. Aged 25-75 years old
  4. Have access to a mobile phone or computer with the Zoom application or a caregiver who is able to assist them with the Zoom application

Exclusion Criteria:

1. Ever diagnosed with breast cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Focus Group Discussion on breast cancer risk prediction report
Woman population with no breast cancer who received the dummy report result
Other: Focus Group Discussion
Each focus group will consist up to five participants in every session, two sessions each for both low and high risk group. Every FGD sessions will last for 1 to 2 hours and be conducted in Indonesian, and will be recorded. Both groups will be asked the following questions: 1) What is your opinion regarding the clarity of information in the dummy breast cancer risk prediction report?; 2) What is your opinion regarding the completeness of information in the dummy breast cancer risk prediction report?; and 3) What is your impression regarding the results presented in the dummy breast cancer risk prediction report?.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Focus Group Discussions
Time Frame: Immediately after exposure to dummy report
To qualitatively investigate participants' perceptions and gather their feedbacks on the clarity, completeness, and their impressions towards the breast cancer risk prediction dummy report. FGD will be transcribed and analyzed using thematic analysis method.
Immediately after exposure to dummy report

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nalagenetics Pte Ltd

Collaborators

SJH Initiatives
MRCCC Siloam Hospitals Semanggi

Investigators

  • Principal Investigator: Samuel J Haryono, Ph.D., MD, SJH Initiatives
  • Study Chair: Faustina A Agatha, S. Biotek, SJH Initiatives
  • Study Chair: Fatma Aldila, MPH, Nalagenetics Pte Ltd
  • Study Chair: Eric A Fernandez, Ph.D., Nalagenetics Pte Ltd
  • Study Chair: Sabrina G Tanu, B. Sci, Nalagenetics Pte Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 8, 2022

Primary Completion (Actual)

February 12, 2023

Study Completion (Actual)

February 12, 2023

Study Registration Dates

First Submitted

September 23, 2022

First Submitted That Met QC Criteria

September 28, 2022

First Posted (Actual)

September 30, 2022

Study Record Updates

Last Update Posted (Actual)

November 13, 2023

Last Update Submitted That Met QC Criteria

November 10, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID-BCRPS-02-20220913

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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