The Perspective of Healthy Individuals on Breast Cancer Risk Prediction Report In The Indonesian Population (PERCEPTION)
Primary Purpose
Breast Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Focus Group Discussion
Sponsored by
About this trial
This is an interventional other trial for Breast Cancer focused on measuring Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Female
- Able to give informed consent
- Aged 25-75 years old
- 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
Sites / Locations
- MRCCC Siloam Hospitals SemanggiRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Focus Group Discussion on breast cancer risk prediction report
Arm Description
Woman population with no breast cancer who received the dummy report result
Outcomes
Primary Outcome Measures
Focus Group Discussions
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05562440
First Posted
September 23, 2022
Last Updated
October 2, 2022
Sponsor
Nalagenetics Pte Ltd
Collaborators
SJH Initiatives, MRCCC Siloam Hospitals Semanggi
1. Study Identification
Unique Protocol Identification Number
NCT05562440
Brief Title
The Perspective of Healthy Individuals on Breast Cancer Risk Prediction Report In The Indonesian Population
Acronym
PERCEPTION
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)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 14, 2022 (Actual)
Primary Completion Date
November 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nalagenetics Pte Ltd
Collaborators
SJH Initiatives, MRCCC Siloam Hospitals Semanggi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Focus Group Discussion
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Focus Group Discussion on breast cancer risk prediction report
Arm Type
Experimental
Arm Description
Woman population with no breast cancer who received the dummy report result
Intervention Type
Other
Intervention Name(s)
Focus Group Discussion
Intervention Description
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?.
Primary Outcome Measure Information:
Title
Focus Group Discussions
Description
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.
Time Frame
Immediately after exposure to dummy report
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
The focus of the study is on breast cancer.
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Female
Able to give informed consent
Aged 25-75 years old
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Astrid Irwanto, Ph.D.
Phone
+65844992126
Email
astrid@nalagenetics.com
First Name & Middle Initial & Last Name or Official Title & Degree
Levana Sani, Bsc
Phone
+62 8179130787
Email
levana@nalagenetics.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel J Haryono, Ph.D., MD
Organizational Affiliation
SJH Initiatives
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Faustina A Agatha, S. Biotek
Organizational Affiliation
SJH Initiatives
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Fatma Aldila, MPH
Organizational Affiliation
Nalagenetics Pte Ltd
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Eric A Fernandez, Ph.D.
Organizational Affiliation
Nalagenetics Pte Ltd
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sabrina G Tanu, B. Sci
Organizational Affiliation
Nalagenetics Pte Ltd
Official's Role
Study Chair
Facility Information:
Facility Name
MRCCC Siloam Hospitals Semanggi
City
Jakarta
State/Province
DKI Jakarta
ZIP/Postal Code
12930
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Faustina Audrey Agatha, S. Biotek
Phone
+6281294642151
Email
agatha_audrey@yahoo.com
First Name & Middle Initial & Last Name & Degree
Dr. dr. Samuel J. Haryono, Sp. B (K) Onk Head
Email
samuelharyono@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26979548
Citation
Hollands GJ, French DP, Griffin SJ, Prevost AT, Sutton S, King S, Marteau TM. The impact of communicating genetic risks of disease on risk-reducing health behaviour: systematic review with meta-analysis. BMJ. 2016 Mar 15;352:i1102. doi: 10.1136/bmj.i1102.
Results Reference
background
PubMed Identifier
32983551
Citation
Vranceanu M, Pickering C, Filip L, Pralea IE, Sundaram S, Al-Saleh A, Popa DS, Grimaldi KA. A comparison of a ketogenic diet with a LowGI/nutrigenetic diet over 6 months for weight loss and 18-month follow-up. BMC Nutr. 2020 Sep 24;6:53. doi: 10.1186/s40795-020-00370-7. eCollection 2020.
Results Reference
background
PubMed Identifier
27423699
Citation
Cutting E, Banchero M, Beitelshees AL, Cimino JJ, Fiol GD, Gurses AP, Hoffman MA, Jeng LJ, Kawamoto K, Kelemen M, Pincus HA, Shuldiner AR, Williams MS, Pollin TI, Overby CL. User-centered design of multi-gene sequencing panel reports for clinicians. J Biomed Inform. 2016 Oct;63:1-10. doi: 10.1016/j.jbi.2016.07.014. Epub 2016 Jul 14.
Results Reference
background
PubMed Identifier
30367635
Citation
Chong HY, Allotey PA, Chaiyakunapruk N. Current landscape of personalized medicine adoption and implementation in Southeast Asia. BMC Med Genomics. 2018 Oct 26;11(1):94. doi: 10.1186/s12920-018-0420-4.
Results Reference
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PubMed Identifier
35358246
Citation
Liu J, Ho PJ, Tan THL, Yeoh YS, Chew YJ, Mohamed Riza NK, Khng AJ, Goh SA, Wang Y, Oh HB, Chin CH, Kwek SC, Zhang ZP, Ong DLS, Quek ST, Tan CC, Wee HL, Li J, Iau PTC, Hartman M. BREAst screening Tailored for HEr (BREATHE)-A study protocol on personalised risk-based breast cancer screening programme. PLoS One. 2022 Mar 31;17(3):e0265965. doi: 10.1371/journal.pone.0265965. eCollection 2022.
Results Reference
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PubMed Identifier
32737321
Citation
Ho WK, Tan MM, Mavaddat N, Tai MC, Mariapun S, Li J, Ho PJ, Dennis J, Tyrer JP, Bolla MK, Michailidou K, Wang Q, Kang D, Choi JY, Jamaris S, Shu XO, Yoon SY, Park SK, Kim SW, Shen CY, Yu JC, Tan EY, Chan PMY, Muir K, Lophatananon A, Wu AH, Stram DO, Matsuo K, Ito H, Chan CW, Ngeow J, Yong WS, Lim SH, Lim GH, Kwong A, Chan TL, Tan SM, Seah J, John EM, Kurian AW, Koh WP, Khor CC, Iwasaki M, Yamaji T, Tan KMV, Tan KTB, Spinelli JJ, Aronson KJ, Hasan SN, Rahmat K, Vijayananthan A, Sim X, Pharoah PDP, Zheng W, Dunning AM, Simard J, van Dam RM, Yip CH, Taib NAM, Hartman M, Easton DF, Teo SH, Antoniou AC. European polygenic risk score for prediction of breast cancer shows similar performance in Asian women. Nat Commun. 2020 Jul 31;11(1):3833. doi: 10.1038/s41467-020-17680-w.
Results Reference
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The Perspective of Healthy Individuals on Breast Cancer Risk Prediction Report In The Indonesian Population
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