Clinical trial NCT05562440: The Perspective of Healthy Individuals on Breast Cancer Risk Prediction Report In The Indonesian Population
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
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Lead sponsor: Nalagenetics Pte Ltd
Sponsor class: INDUSTRY
Collaborators: name: SJH Initiatives
name: MRCCC Siloam Hospitals Semanggi
First posted: 2022-09-30
Enrollment: 10
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Focus Group Discussion
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Focus Group Discussions
timeFrame: Immediately after exposure to dummy report
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: MRCCC Siloam Hospitals Semanggi
state: DKI Jakarta
Study officials:
affiliation: SJH Initiatives
name: Samuel J Haryono, Ph.D., MD
role: PRINCIPAL_INVESTIGATOR
affiliation: SJH Initiatives
name: Faustina A Agatha, S. Biotek
role: STUDY_CHAIR
affiliation: Nalagenetics Pte Ltd
name: Fatma Aldila, MPH
role: STUDY_CHAIR
affiliation: Nalagenetics Pte Ltd
name: Eric A Fernandez, Ph.D.
role: STUDY_CHAIR
affiliation: Nalagenetics Pte Ltd
name: Sabrina G Tanu, B. Sci
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.
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.