The DIALOGUE Study: Swiss-Korean Billateral Collaboration

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.

Conditions

• Hereditary Cancer
• Breast Cancer
• Ovarian Cancer

Interventions

OTHER

Adapted 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).

OTHER

Targeted 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.

Sponsors & Collaborators

• Yonsei University

  collaborator OTHER

• University Hospital, Basel, Switzerland

  collaborator OTHER

• Hopital du Jura, Delemont, Switzerland

  collaborator UNKNOWN

• Department of Computer Science Yonsei University, Seoul, Korea

  collaborator UNKNOWN

• National Cancer Center, Korea

  collaborator OTHER_GOV

• Chungnam National University

  collaborator OTHER

• Ente Ospedaliero Cantonale, Ticino, Switzerland

  collaborator OTHER

• Swiss National Science Foundation

  collaborator OTHER

• Insel Gruppe AG, University Hospital Bern

  collaborator OTHER

• University Hospital, Geneva

  collaborator OTHER

• Kantonal Hospital Winterthur, Medical Oncology

  collaborator UNKNOWN

• Kantonal Hospital Fribourg, Breast Center

  collaborator UNKNOWN

• Hirslanden, Grangettes, Geneva

  collaborator UNKNOWN

• Kantonal Hospital Solothurn, Olten

  collaborator UNKNOWN

• Kantonal Hospital Graubunden

  collaborator UNKNOWN

• Kantonal Hospital Wallis, Sion

  collaborator UNKNOWN

• Zurich Breast Center

  collaborator UNKNOWN

• University of Basel

  lead OTHER

Principal Investigators

• Maria C. Katapodi, PhD · Department of Clinical Research, University of Basel

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

19 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-04-15

Primary Completion

2025-12-31

Completion

2025-12-31

Countries

• Switzerland

Study Locations