The DIALOGUE Study: Swiss-Korean Billateral Collaboration

NCT04214210 | Recruiting DMC

• 1 other identifier: IZKSZ3_188408 / 1
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 8

Brief 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. 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. 2.Develop the K-CASCADE research infrastructure in Korea by expanding the research infrastructure developed by the CASCADE Consortium in Switzerland
3. 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. 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

Keywords

cascade genetic testing; disclosure of genetic test results; family communication; web-based platform; efficacy; implementation outcomes

Outcome Measures

Primary Outcomes (9)

• 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

• 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

• 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

• 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

• Reach

  Change in the absolute number of individuals willing to participate in the study

  Baseline, 12 months, 24 months, 36 months, 48 months

• Effectiveness

  Change in number of "relative invites" initiated through the website

  Baseline, 12 months, 24 months, 36 months, 48 months

• Adoption

  Change in number of clinical sites willing to participate in the study

  Baseline, 12 months, 24 months, 36 months, 48 months

• Implementation

  Change in number of mutation carriers referred to the web-site

  Baseline, 12 months, 24 months, 36 months, 48 months

• Maintenance

  Change in number of visits to the web-site

  Baseline, 12 months, 24 months, 36 months, 48 months

Secondary Outcomes (8)

• Acceptability - investigator developed

  Baseline and 6 month post-intervention

• K-CASCADE

  through study completion, an average of 4 years

• Cancer diagnoses

  Baseline, 12 months, 24 months, 36 months, 48 months

• Cancer surveillance

  Baseline, 12 months, 24 months, 36 months, 48 months

• Breast cancer risk factors and genetics knowledge index

  Baseline, 2 month and 6 month post-intervention

Study Arms (2)

Tailored Family Gene Toolkit

EXPERIMENTAL

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.

Other: Adapted Family Gene Toolkit

Targeted intervention

ACTIVE COMPARATOR

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.

Other: Targeted intervention

Interventions

Adapted Family Gene Toolkit OTHER

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).

Tailored Family Gene Toolkit

Targeted intervention OTHER

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.

Targeted intervention

Eligibility Criteria

• Age: 19 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Basel: lead
• Yonsei University: collaborator
• University Hospital, Basel, Switzerland: collaborator
• Hopital du Jura, Delemont, Switzerland: collaborator
• Department of Computer Science Yonsei University, Seoul, Korea: collaborator
• National Cancer Center, Korea: collaborator
• Chungnam National University: collaborator
• Ente Ospedaliero Cantonale, Ticino, Switzerland: collaborator
• Swiss National Science Foundation: collaborator
• Insel Gruppe AG, University Hospital Bern: collaborator
• University Hospital, Geneva: collaborator
• Kantonal Hospital Winterthur, Medical Oncology: collaborator
• Kantonal Hospital Fribourg, Breast Center: collaborator
• Hirslanden, Grangettes, Geneva: collaborator
• Kantonal Hospital Solothurn, Olten: collaborator
• Kantonal Hospital Graubunden: collaborator
• Kantonal Hospital Wallis, Sion: collaborator
• Zurich Breast Center: collaborator

Study Sites (8)

HFR Fribourg - Hôpital cantonal

Fribourg, Canton of Fribourg, 1752, Switzerland

NOT YET RECRUITING

Hirslanden Clinic Des Grangettes

Geneva, Canton of Geneva, 1224, Switzerland

NOT YET RECRUITING

Hopital du Jura - Service d' Oncology

Delémont, Canton of Jura, 2800, Switzerland

RECRUITING

Kantonalspital Winterthur

Winterthur, Canton of Zurich, 8401, Switzerland

NOT YET RECRUITING

University Hospital Basel

Basel, 4056, Switzerland

RECRUITING

Istituto Oncologico della Zvizzera Italiana

Bellinzona, 6962, Switzerland

RECRUITING

Universitatklinik fur Medizinische Onkologie, Inselspital

Bern, 3010, Switzerland

RECRUITING

Unite d'Oncogenetique et de Prevention des Cancers

Geneva, 1205, Switzerland

RECRUITING

Related Publications (2)

• Aceti M, Caiata-Zufferey M, Pedrazzani C, Schweighoffer R, Kim SY, Baroutsou V, Katapodi MC, Kim S; CASCADE and K-CASCADE Consortia. Modes of responsibility in disclosing cancer genetic test results to relatives: An analysis of Swiss and Korean narrative data. Patient Educ Couns. 2024 Jun;123:108202. doi: 10.1016/j.pec.2024.108202. Epub 2024 Feb 16.

  PMID: 38395023 DERIVED

• Kim S, Aceti M, Baroutsou V, Burki N, Caiata-Zufferey M, Cattaneo M, Chappuis PO, Ciorba FM, Graffeo-Galbiati R, Heinzelmann-Schwarz V, Jeong J, Jung MM, Kim SW, Kim J, Lim MC, Ming C, Monnerat C, Park HS, Park SH, Pedrazzani CA, Rabaglio M, Ryu JM, Saccilotto R, Wieser S, Zurrer-Hardi U, Katapodi MC. Using a Tailored Digital Health Intervention for Family Communication and Cascade Genetic Testing in Swiss and Korean Families With Hereditary Breast and Ovarian Cancer: Protocol for the DIALOGUE Study. JMIR Res Protoc. 2021 Jun 11;10(6):e26264. doi: 10.2196/26264.

  PMID: 34114954 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Maria C. Katapodi, PhD

  Department of Clinical Research, University of Basel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria C Katapodi, PhD

CONTACT

+41791095163; maria.katapodi@unibas.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Nursing, Department of Clinical Research

Study Record Dates

• First Submitted: November 3, 2019
• First Posted: January 2, 2020
• Study Start: April 15, 2022
• Primary Completion: May 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 14, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Upon completion of analyses addressing primary aims of the study - for 10 years
• Access Criteria: Request protocol to CASCADE Consortium

Locations

CH (8)