Digital platform for communication of genetic test results in cancer families

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

This study is testing a new digital tool to help families affected by hereditary breast and ovarian cancer share and understand genetic test results better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 228 (estimated)
• Ages: 19 Years to 99 Years
• Sex: All
• Sponsor: University of Basel (Academic / other)
• Locations: 8 sites (Delémont, Jura and 7 other locations)
• Trial ID: NCT04214210 on ClinicalTrials.gov

What this trial studies

This study aims to develop and evaluate a digital health platform designed to enhance communication of genetic test results among families affected by hereditary breast and ovarian cancer (HBOC). The platform will adapt the Family Gene Toolkit (FGT) to be culturally relevant for Swiss and Korean populations, incorporating modules that educate users about cancer genetics, provide support for genetic testing decisions, and improve communication skills. Participants will be randomized to receive the intervention or a comparator, with follow-up data collected to assess the platform's effectiveness in facilitating communication and cascade testing.

Who should consider this trial

Good fit: Ideal candidates include individuals identified with a pathogenic variant associated with HBOC or those with close relatives affected by HBOC who can communicate in German, French, Italian, English, or Korean.

Not a fit: Patients who do not have any family members or those unable to provide informed consent due to mental or physical illness may not benefit from this study.

Why it matters

Potential benefit: If successful, this platform could significantly improve the communication of genetic information among families, leading to better health outcomes through timely cascade testing.

How similar studies have performed: Other studies have shown success with similar digital health interventions in improving communication and education in genetic testing contexts.

Eligibility criteria

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.

Where this trial is running

Delémont, Jura and 7 other locations

• Hopital du Jura - Service d' Oncology — Delémont, Jura, Switzerland (Recruiting)
• Kantonalspital Winterthur — Winterthur, Zurich, Switzerland (Not_yet_recruiting)
• University Hospital Basel — Basel, Switzerland (Recruiting)
• Istituto Oncologico della Zvizzera Italiana — Bellinzona, Switzerland (Recruiting)
• Universitatklinik fur Medizinische Onkologie, Inselspital — Bern, Switzerland (Recruiting)
• HFR Fribourg - Hôpital cantonal — Fribourg, Switzerland (Not_yet_recruiting)
• Unite d'Oncogenetique et de Prevention des Cancers — Geneva, Switzerland (Recruiting)
• Hirslanden Clinic Des Grangettes — Geneva, Switzerland (Not_yet_recruiting)

Study contacts

• Principal investigator: Maria C. Katapodi, PhD — Department of Clinical Research, University of Basel
• Study coordinator: Maria C Katapodi, PhD

Conditions Hereditary Cancer; Breast Cancer; Ovarian Cancer; cascade genetic testing; disclosure of genetic test results; family communication; web-based platform; efficacy