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

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 99
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Switzerland
University Hospital Basel
RECRUITING
Basel
Istituto Oncologico della Zvizzera Italiana
RECRUITING
Bellinzona
Universitatklinik fur Medizinische Onkologie, Inselspital
RECRUITING
Bern
Hopital du Jura - Service d' Oncology
RECRUITING
Delémont
HFR Fribourg - Hôpital cantonal
NOT_YET_RECRUITING
Fribourg
Hirslanden Clinic Des Grangettes
NOT_YET_RECRUITING
Geneva
Unite d'Oncogenetique et de Prevention des Cancers
RECRUITING
Geneva
Kantonalspital Winterthur
NOT_YET_RECRUITING
Winterthur
Contact Information
Primary
Maria C Katapodi, PhD
maria.katapodi@unibas.ch
+41791095163
Time Frame
Start Date: 2022-04-15
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 228
Treatments
Experimental: Tailored Family Gene Toolkit
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.
Active_comparator: Targeted intervention
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.
Related Therapeutic Areas
Sponsors
Collaborators: Yonsei University, Insel Gruppe AG, University Hospital Bern, Zurich Breast Center, Ente Ospedaliero Cantonale, Ticino, Switzerland, Department of Computer Science Yonsei University, Seoul, Korea, Kantonal Hospital Winterthur, Medical Oncology, Hirslanden, Grangettes, Geneva, Chungnam National University, Kantonal Hospital Solothurn, Olten, National Cancer Center, Korea, University Hospital, Basel, Switzerland, Hopital du Jura, Delemont, Switzerland, Kantonal Hospital Wallis, Sion, University Hospital, Geneva, Kantonal Hospital Fribourg, Breast Center, Swiss National Science Foundation, Kantonal Hospital Graubunden
Leads: University of Basel

This content was sourced from clinicaltrials.gov