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

NCT ID: NCT05562440

Last Updated: 2023-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-08

Study Completion Date

2023-02-12

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Focus Group Discussion
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Focus Group Discussion on breast cancer risk prediction report

Woman population with no breast cancer who received the dummy report result

Group Type EXPERIMENTAL

Focus Group Discussion

Intervention Type OTHER

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?.

Interventions

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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?.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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SJH Initiatives

UNKNOWN

Sponsor Role collaborator

MRCCC Siloam Hospitals Semanggi

UNKNOWN

Sponsor Role collaborator

Nalagenetics Pte Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Samuel J Haryono, Ph.D., MD

Role: PRINCIPAL_INVESTIGATOR

SJH Initiatives

Faustina A Agatha, S. Biotek

Role: STUDY_CHAIR

SJH Initiatives

Fatma Aldila, MPH

Role: STUDY_CHAIR

Nalagenetics Pte Ltd

Eric A Fernandez, Ph.D.

Role: STUDY_CHAIR

Nalagenetics Pte Ltd

Sabrina G Tanu, B. Sci

Role: STUDY_CHAIR

Nalagenetics Pte Ltd

Locations

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MRCCC Siloam Hospitals Semanggi

Jakarta, DKI Jakarta, Indonesia

Site Status

Countries

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Indonesia

References

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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.

Reference Type BACKGROUND
PMID: 26979548 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32983551 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27423699 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30367635 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35358246 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32737321 (View on PubMed)

Other Identifiers

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ID-BCRPS-02-20220913

Identifier Type: -

Identifier Source: org_study_id

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