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

Sponsor
Nalagenetics Pte Ltd (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05562440
Collaborator
SJH Initiatives (Other), MRCCC Siloam Hospitals Semanggi (Other)
20
1
1
3.5
5.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Focus Group Discussion
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Focus Group DiscussionFocus Group Discussion
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
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)
Actual Study Start Date :
Sep 14, 2022
Anticipated Primary Completion Date :
Nov 30, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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?.

Outcome Measures

Primary Outcome Measures

  1. Focus Group Discussions [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 75 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 MRCCC Siloam Hospitals Semanggi Jakarta DKI Jakarta Indonesia 12930

Sponsors and Collaborators

  • Nalagenetics Pte Ltd
  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Nalagenetics Pte Ltd
ClinicalTrials.gov Identifier:
NCT05562440
Other Study ID Numbers:
  • ID-BCRPS-02-20220913
First Posted:
Sep 30, 2022
Last Update Posted:
Oct 4, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nalagenetics Pte Ltd
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 4, 2022