NCT05562440

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 30, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

November 8, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2023

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

3 months

First QC Date

September 23, 2022

Last Update Submit

November 10, 2023

Conditions

Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    Immediately after exposure to dummy report

Study Arms (1)

Focus Group Discussion on breast cancer risk prediction report

EXPERIMENTAL

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

Other: Focus Group Discussion

Interventions

Focus Group DiscussionOTHER

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?.

Focus Group Discussion on breast cancer risk prediction report

Eligibility Criteria

Age25 Years - 75 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe focus of the study is on breast cancer.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \. Ever diagnosed with breast cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MRCCC Siloam Hospitals Semanggi

Jakarta, DKI Jakarta, 12930, Indonesia

Location

Related Publications (6)

  • 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.

    PMID: 26979548BACKGROUND

  • 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.

    PMID: 32983551BACKGROUND

  • 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.

    PMID: 27423699BACKGROUND

  • 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.

    PMID: 30367635BACKGROUND

  • 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.

    PMID: 35358246BACKGROUND

  • 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.

    PMID: 32737321BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Samuel J Haryono, Ph.D., MD

    SJH Initiatives

    PRINCIPAL INVESTIGATOR

  • 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 CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Focus Group Discussion
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2022

First Posted

September 30, 2022

Study Start

November 8, 2022

Primary Completion

February 12, 2023

Study Completion

February 12, 2023

Last Updated

November 13, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)