<Aims and rationale>
The study proposes to build and evaluate a scalable digital health platform to support communication of genetic test results in HBOC families in routine practice. The Family Gene Toolkit (FGT), a web-based intervention designed to reduce psychological distress and increase family communication about genetic test results within HBOC families will be adapted to be less resource intensive and thus disseminated to a larger audience without increasing costs. The study also proposes developing the K-CASCADE research infrastructure in order to measure outcomes of an embedded randomized trial.
The Specific Aims of the project are:
1) Develop a digital health solution to support the communication of cancer predisposition among HBOC families, based on linguistic and cultural adaptation methods of the Family Gene Toolkit for the Swiss and Korean population 
2) Develop the K-CASCADE research infrastructure in Korea by expanding an existing research infrastructure developed by the CASCADE Consortium in Switzerland 
3) Evaluate the efficacy of the aforementioned digital solution on psychological distress and communication of genetic test results, as well as knowledge of cancer genetics, coping, decision making and quality of life
4) Explore the reach, effectiveness, adoption, implementation, and maintenance of the aforementioned digital solution

 Health Services Research

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.

Arm Label

Target Number of Participant

Arm Type

Arm Description

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.

Arm Label

Target Number of Participant

Arm Type

Arm Description

The comparison website should provide targeted information about HBOC and enable sharing genetic test results. Currently there are no available web-based interventions to facilitate family communication and cascade genetic screening for HBOC in Korean or in any of the Swiss national languages. The Korean team will define the contents of the comparison website that will mimic the structure and function of an existing website i.e., www.kintalk.org., which is already available in the US.

Gender

Age

Description

Eligible participants will be females and males (expected 4 females : 1 male) who have been identified through genetic testing as carrying a pathogenic variant associated with HBOC (probands) and their first- and second-degree relatives (parents, siblings, offspring, and aunts, uncles, nieces, nephews, and grandparents) and their first cousins. Probands and relatives may have a cancer diagnosis (expected 5 breast cancer patients : 1 ovarian cancer patient) or they may be cancer free.

- 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.

Profile of Mood States (POMS)

Baseline, 2 months and 6 months post-intervention

Change in proportion of informed relatives

Baseline, 2 months and 6 months post-intervention

Informing Relatives Inventory

Baseline, 2 months and 6 months post-intervention

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

Acceptability: Change in attitude toward the intervention

Baseline and 6 month post-intervention

K-CASCADE: Number of individuals who take part in the study in Korea

through study completion, an average of 4 years

Cancer diagnoses: Change in number of cancer diagnoses reported by participants

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

Cancer surveillance: Change in number of MRIs and mammograms reported by participants

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

Brief COPE

Baseline, 2 month and 6 month post-intervention

Decision regret

Baseline, 2 month and 6 month post-intervention

Decision conflict: Change in decision conflict for untested relatives

Baseline, 2 month and 6 month post-intervention