Paradigmatic Approach to Support Personalized Counseling With Digital Health (iKNOW)

Dorothee Speiser; Maren Heibges; Laura Besch; Caren Hilger; Marie Keinert; Katharina Klein; Gudrun Rauwolf; Christine Schmid; Sven Schulz-Niethammer; Steffi Stegen; Viola Westfal; Isabell Witzel; Benedikt Zang; Friederike Kendel; Markus A Feufel

doi:10.2196/41179

Paradigmatic Approach to Support Personalized Counseling With Digital Health (iKNOW)

JMIR Form Res. 2023 Apr 21:7:e41179. doi: 10.2196/41179.

Authors

Affiliations

¹ Department of Gynecology with Breast Center, Hereditary Breast and Ovarian Cancer Center, Charité - Universitätsmedizin Berlin, Berlin, Germany.
² Division of Ergonomics, Department of Psychology and Ergonomics, Technische Universität Berlin, Berlin, Germany.
³ Gender in Medicine, Charité - Universitätsmedizin Berlin, Berlin, Germany.
⁴ Department of Clinical Psychology and Psychotherapy, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen-Nuernberg, Germany.
⁵ BRCA-Netzwerk e.V., Hilfe bei familiären Krebserkrankungen, Bonn, Germany.
⁶ Department of Gynecology, Hereditary Breast and Ovarian Cancer Center, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

^# Contributed equally.

PMID: 37083496
PMCID: PMC10163406
DOI: 10.2196/41179

Abstract

iKNOW is the first evidence-based digital tool to support personalized counseling for women in Germany with a hereditary cancer risk. The counseling tool is designed for carriers of pathogenic gBRCA (germline breast cancer gene) variants that increase the lifetime risk of breast and ovarian cancer. Carriers of pathogenic variants are confronted with complex, individualized risk information, and physicians must be able to convey this information in a comprehensible way to enable preference-sensitive health decisions. In this paper, we elaborate on the clinical, regulatory, and practical premises of personalized counseling in Germany. By operationalizing these premises, we formulate 5 design principles that, we suggest, are specific enough to develop a digital tool (eg, iKNOW), yet wide-ranging enough to inform the development of counseling tools for personalized medicine more generally: (1) digital counseling tools should implement the current standard of care (eg, based on guidelines); (2) digital counseling tools should help to both standardize and personalize the counseling process (eg, by enabling the preference-sensitive selection of counseling contents from a common information base); (3) digital counseling tools should make complex information easy to access both cognitively (eg, by using evidenced-based risk communication formats) and technically (eg, by means of responsive design for various devices); (4) digital counseling tools should respect the counselee's data privacy rights (eg, through strict pseudonymization and opt-in consent); and (5) digital counseling tools should be systematically and iteratively evaluated with the users in mind (eg, using formative prototype testing to ensure a user-centric design and a summative multicenter, randomized controlled trial). On the basis of these paradigmatic design principles, we hope that iKNOW can serve as a blueprint for the development of more digital innovations to support personalized counseling approaches in cancer medicine.

Keywords: BRCA; breast cancer; cancer risk; digital health; genetic counseling; hereditary breast and ovarian cancer; hereditary cancer; online counseling tool; ovarian cancer; risk communication; user-centered design principles.

©Dorothee Speiser, Maren Heibges, Laura Besch, Caren Hilger, Marie Keinert, Katharina Klein, Gudrun Rauwolf, Christine Schmid, Sven Schulz-Niethammer, Steffi Stegen, Viola Westfal, Isabell Witzel, Benedikt Zang, Friederike Kendel, Markus A Feufel. Originally published in JMIR Formative Research (https://formative.jmir.org), 21.04.2023.