RecruitingNot ApplicableNCT04214210

The DIALOGUE Study: Swiss-Korean Billateral Collaboration

The DIALOGUE Study: Using Digital Health to Improve Care for Families With Predisposition to Hereditary Cancer


Sponsor

University of Basel

Enrollment

228 participants

Start Date

Apr 15, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 19 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study (the DIALOGUE Study) is examining how people in Switzerland and Korea who carry a hereditary gene variant for breast and ovarian cancer syndrome (HBOC) make decisions about genetic testing and preventive treatment, and how family communication affects those decisions. **You may be eligible if...** - You speak German, French, Italian, English, or Korean - You live in Switzerland or South Korea - You carry a gene mutation associated with hereditary breast and ovarian cancer (HBOC) - You have at least one first- or second-degree family member with HBOC - You are mentally able to provide informed consent and complete surveys **You may NOT be eligible if...** - You have no family members with HBOC - You have a prior diagnosis of a mental illness - You are physically ill and unable to complete the baseline survey - You do not have access to the internet via a computer, tablet, or smartphone Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERAdapted Family Gene Toolkit

Five web-based modules designed to increase knowledge of cancer genetics (Module 1); provide decisional support for genetic testing (Module 2); increase active coping to common challenges faced by HBOC families (Module 3); provide a five-steps, skills-building communication training (Module 4); increase knowledge about management of hereditary cancer risk based on the most updated recommendations from the National Comprehensive Cancer Network (Module 5).

OTHERTargeted intervention

The comparison website will provide targeted information about HBOC and enable sharing genetic test results.The Korean team will define the contents of the comparison website that will mimic the structure and function of a 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 three Swiss national languages. The tailored and the targeted platform will be technically implemented in the same system, to track access and usage of the platform and provide a user-friendly experience.


Locations(8)

HFR Fribourg - Hôpital cantonal

Fribourg, Canton of Fribourg, Switzerland

Hirslanden Clinic Des Grangettes

Geneva, Canton of Geneva, Switzerland

Hopital du Jura - Service d' Oncology

Delémont, Canton of Jura, Switzerland

Kantonalspital Winterthur

Winterthur, Canton of Zurich, Switzerland

University Hospital Basel

Basel, Switzerland

Istituto Oncologico della Zvizzera Italiana

Bellinzona, Switzerland

Universitatklinik fur Medizinische Onkologie, Inselspital

Bern, Switzerland

Unite d'Oncogenetique et de Prevention des Cancers

Geneva, Switzerland

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NCT04214210


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