Clinical trial · Interventional
The DIALOGUE Study: Swiss-Korean Billateral Collaboration
The DIALOGUE Study: Using Digital Health to Improve Care for Families With Predisposition to Hereditary Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In Hereditary Breast and Ovarian Cancer (HBOC) communication of genetic test results with relatives is essential to cascade testing. According to privacy laws those identified with the pathogenic variant have the sole responsibility to share information about test results and implications to relatives. Up to 50% of biological relatives are unaware of relevant genetic information, suggesting that benefits of genetic testing are not communicated effectively. Interventions designed to help mutation carriers communicate with relatives are critical for cascade genetic testing. Technology could play a significant role in facilitating communication and genetic education within HBOC families The investigators will develop a digital health platform for Swiss and Korean HBOC families. The digital platform will be based on the Family Gene Toolkit (FGT), a web-based intervention designed to enhance communication of genetic test results within HBOC families that has been tested for acceptability, usability, and participant satisfaction. The investigators will expand a Swiss research infrastructure to enable future collaborative projects between the two countries. Specific Aims 1. Develop a digital health platform to support the communication of cancer predisposition in HBOC families, based on linguistic and cultural adaptation methods of the FGT for the Swiss and Korean population 2. Develop the K-CASCADE research infrastructure in Korea by expanding the research infrastructure developed by the CASCADE Consortium in Switzerland 3. Evaluate the efficacy of the digital platform on psychological distress and communication of genetic test results, and knowledge of cancer genetics, coping, and decision making 4. Explore the reach, effectiveness, adoption, implementation, and maintenance of the digital platform The digital platform will be based on the FGT with linguistic adaptation for web and mobile access. Aim 1 will be achieved with focus groups with 20-24 HBOC mutation carriers and relatives and 6-10 providers involved in genetic services. For Aim 2, a Korean database of HBOC families (K-CASCADE) will be based on the Swiss CASCADE database. For Aim 3, feasibility and efficacy of the digital solution against the comparison intervention will be assessed in a randomized trial with a sample of 104 HBOC mutation carriers (52 in each arm). Aim 4 will be achieved with survey and interview data collected from HBOC families and healthcare providers during all phases of the study.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Hereditary Cancer | Hereditary Malignant Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adapted Family Gene Toolkit | Other | — | UNRESOLVED |
| Targeted intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Tailored Family Gene Toolkit
- description
- The tailored FGT will include 5 modules designed to increase knowledge of cancer genetics (1); provide decisional support for genetic testing (2); increase active coping to challenges faced by HBOC families (3); provide a 5-steps, skills-building communication training (4); and provide information about management of hereditary cancer risk (5). Messages will involve shallow tailoring (e.g. sex of mutation carrier), and deep tailoring with complex elements of relevance (e.g. coping style). Tailoring will be based on personalization, tailored feedback, and content matching, based on Swiss and Korean languages and legislation, health insurance policy, and cultural values. Participants will be asked to complete the 5 modules within 4 weeks after they first engage with the intervention. The 4-week interval will enable learning new information while having time to reflect and act. They will receive email alerts to complete the 5 modules with the URL link directing them to the FGT.
- interventionNames
- Other: Adapted Family Gene Toolkit
- type
- ACTIVE_COMPARATOR
- label
- Targeted intervention
- description
- The comparator will provide targeted information about HBOC and enable sharing genetic test results. The Korean team will define the contents of the comparator that will mimic the structure and function of an existing website, already available in the US. The Korean team will create a translation process protocol, and share this guide for further translations from English into Korean and the three Swiss national languages. Both trial arms the tailored and the targeted platform will be technically implemented in the same system, in order to track access and usage of the platform and provide a user-friendly experience to participants. The Swiss team will also provide the implementation of the comparison website.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Speak and read German, French, Italian, English, or Korean * Residence in Switzerland or in Korea * Has been identified with a pathogenic variant associated with HBOC or * Has ≥1 first-, second-degree relative or first cousing with HBOC * Mentally able to provide informed consent Exclusion Criteria: * mutation carriers who do not have any family members; * husbands and partners, although they may play an important role in decisions for genetic testing and risk management of disease, will not be included in the study; * participants with a prior diagnosis of a mental disease and those unable to provide informed consent; * those physically ill and not being able to complete a baseline survey; * those without access to the web through a computer, tablet, or smartphone.
References
Publications (3)
- DERIVEDJin J, Han J, Kim SY, Katapodi MC, Kim S. Family Caring, Culture, and Communication: Barriers to BRCA-Related Risk Disclosure in Korea-A Qualitative Study. Semin Oncol Nurs. 2026 Apr;42(2):152146. doi: 10.1016/j.soncn.2026.152146. Epub 2026 Feb 9. PMID 41667352
- DERIVEDAceti M, Caiata-Zufferey M, Pedrazzani C, Schweighoffer R, Kim SY, Baroutsou V, Katapodi MC, Kim S; CASCADE and K-CASCADE Consortia. Modes of responsibility in disclosing cancer genetic test results to relatives: An analysis of Swiss and Korean narrative data. Patient Educ Couns. 2024 Jun;123:108202. doi: 10.1016/j.pec.2024.108202. Epub 2024 Feb 16. PMID 38395023
- DERIVEDKim S, Aceti M, Baroutsou V, Burki N, Caiata-Zufferey M, Cattaneo M, Chappuis PO, Ciorba FM, Graffeo-Galbiati R, Heinzelmann-Schwarz V, Jeong J, Jung MM, Kim SW, Kim J, Lim MC, Ming C, Monnerat C, Park HS, Park SH, Pedrazzani CA, Rabaglio M, Ryu JM, Saccilotto R, Wieser S, Zurrer-Hardi U, Katapodi MC. Using a Tailored Digital Health Intervention for Family Communication and Cascade Genetic Testing in Swiss and Korean Families With Hereditary Breast and Ovarian Cancer: Protocol for the DIALOGUE Study. JMIR Res Protoc. 2021 Jun 11;10(6):e26264. doi: 10.2196/26264. PMID 34114954