Breast Cancer Clinical Trial
— DIALOGUEOfficial title:
The DIALOGUE Study: Using Digital Health to Improve Care for Families With Predisposition to Hereditary Cancer
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 | Recruiting |
Enrollment | 228 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 99 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital Basel | Basel | |
Switzerland | Istituto Oncologico della Zvizzera Italiana | Bellinzona | |
Switzerland | Universitatklinik fur Medizinische Onkologie, Inselspital | Bern | |
Switzerland | Hopital du Jura - Service d' Oncology | Delémont | Jura |
Switzerland | HFR Fribourg - Hôpital cantonal | Fribourg | |
Switzerland | Hirslanden Clinic Des Grangettes | Geneva | |
Switzerland | Unite d'Oncogenetique et de Prevention des Cancers | Geneva | |
Switzerland | Kantonalspital Winterthur | Winterthur | Zurich |
Lead Sponsor | Collaborator |
---|---|
University of Basel | Chungnam National University, Department of Computer Science Yonsei University, Seoul, Korea, Ente Ospedaliero Cantonale, Ticino, Switzerland, Hopital du Jura, Delemont, Switzerland, Insel Gruppe AG, University Hospital Bern, National Cancer Center, Korea, Swiss National Science Foundation, University Hospital, Basel, Switzerland, University Hospital, Geneva, Yonsei University |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Profile of Mood States (POMS) | Change in psychological distress of mutation carriers and relatives. The higher the score the higher the psychological distress. | Baseline, 2 months and 6 months post-intervention | |
Primary | Change in proportion of informed relatives | Change in proportion of relatives that were invited to use the platform(s) over overall number of relatives eligible for cascade genetic testing | Baseline, 2 months and 6 months post-intervention | |
Primary | Informing Relatives Inventory | Change in intention of mutation carriers to inform relatives about pathogenic variant and need for cascade genetic testing. The higher the score the higher the intention to inform relatives. | Baseline, 2 months and 6 months post-intervention | |
Primary | Intention to have genetic testing | 1 item, 7-point Likert-type scale ranging from 1 to 7 and assessing change in intention of untested, at risk relatives to have genetic testing. The higher the score the higher the intention to have genetic testing. | Baseline, 2 months and 6 months post-intervention | |
Primary | Reach | Change in the absolute number of individuals willing to participate in the study | Baseline, 12 months, 24 months, 36 months, 48 months | |
Primary | Effectiveness | Change in number of "relative invites" initiated through the website | Baseline, 12 months, 24 months, 36 months, 48 months | |
Primary | Adoption | Change in number of clinical sites willing to participate in the study | Baseline, 12 months, 24 months, 36 months, 48 months | |
Primary | Implementation | Change in number of mutation carriers referred to the web-site | Baseline, 12 months, 24 months, 36 months, 48 months | |
Primary | Maintenance | Change in number of visits to the web-site | Baseline, 12 months, 24 months, 36 months, 48 months | |
Secondary | Acceptability - investigator developed | Change in attitude toward the intervention based on 16 items, 7 point Likert type scale. Minimum score 16, maximum 112, higher score indicates better acceptability | Baseline and 6 month post-intervention | |
Secondary | K-CASCADE | Number of individuals who take part in the study in Korea | through study completion, an average of 4 years | |
Secondary | Cancer diagnoses | Change in number of cancer diagnoses reported by participants | Baseline, 12 months, 24 months, 36 months, 48 months | |
Secondary | Cancer surveillance | Change in number of MRIs and mammograms reported by participants | Baseline, 12 months, 24 months, 36 months, 48 months | |
Secondary | Breast cancer risk factors and genetics knowledge index | Change in genetic literacy and knowledge of genetic and epidemiological breast cancer risk factors. Minimum score 0, maximum score 36, higher score indicates higher knowledge of risk factors | Baseline, 2 month and 6 month post-intervention | |
Secondary | Brief Cope | Change in number of participants who engage in active coping e.g. information seeking vs. avoidance | Baseline, 2 month and 6 month post-intervention | |
Secondary | Decision regret | Change in decision regret for mutation carriers. Minimum score 5, maximum score 35, higher score means higher decision regret | Baseline, 2 month and 6 month post-intervention | |
Secondary | Decision conflict | Change in decision conflict for untested relatives. Minimum score 16, maximum score 112, higher score means higher decision conflict | Baseline, 2 month and 6 month post-intervention |
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