NCT04214210Completed
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 · Last updated 13 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 128 (actual)
- First submitted
- 3 Nov 2019
- Start date
- 15 Apr 2022
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- University of Basel
- Diseases
- Ovarian cancer
- NCT number
- NCT04214210
What you commit to
- Study type: Interventional
- Participants enrolled: 128
- From 15 Apr 2022 to the primary completion date, 31 Dec 2025
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- participants with a prior diagnosis of a mental disease and those unable to provide informed consent;
Other illness
- 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;
Other
- mutation carriers who do not have any family members;
- those physically ill and not being able to complete a baseline survey;
- those without access to the web through a computer, tablet, or smartphone.
Who the study is looking for
- 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
Age in the registry: 19 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Basel Coordinator of this site? Confirm its status | Basel | Switzerland | Unknown status |
| Istituto Oncologico della Zvizzera Italiana Coordinator of this site? Confirm its status | Bellinzona | Switzerland | Unknown status |
| Universitatklinik fur Medizinische Onkologie, Inselspital Coordinator of this site? Confirm its status | Bern | Switzerland | Unknown status |
| Hopital du Jura - Service d' Oncology Coordinator of this site? Confirm its status | Delémont | Switzerland | Unknown status |
| HFR Fribourg - Hôpital cantonal Coordinator of this site? Confirm its status | Fribourg | Switzerland | Unknown status |
| Hirslanden Clinic Des Grangettes Coordinator of this site? Confirm its status | Geneva | Switzerland | Unknown status |
| Unite d'Oncogenetique et de Prevention des Cancers Coordinator of this site? Confirm its status | Geneva | Switzerland | Unknown status |
| Kantonalspital Winterthur Coordinator of this site? Confirm its status | Winterthur | Switzerland | Unknown status |
Related publications
- Family Caring, Culture, and Communication: Barriers to BRCA-Related Risk Disclosure in Korea-A Qualitative Study.Semin Oncol Nurs · 2026 · PMID 41667352
This page is information, not medical advice. Discuss any trial with your doctor.