sing digital health to improve care for families with hereditary cancer - The DIALOGUE study
- Conditions
- Neoplasms
- Registration Number
- KCT0005643
- Lead Sponsor
- Yonsei University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 540
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.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Profile of Mood States (POMS);Change in proportion of informed relatives;Informing Relatives Inventory;Intention to have genetic testing;Reach: Change in the absolute number of individuals willing to participate in the study;Effectiveness: Change in number of "relative invites" initiated through the website;Adoption: Change in number of clinical sites willing to participate in the study;Implementation: Change in number of mutation carriers referred to the web-site;Maintenance: Change in number of visits to the web-site
- Secondary Outcome Measures
Name Time Method Acceptability: Change in attitude toward the intervention;K-CASCADE: Number of individuals who take part in the study in Korea;Cancer diagnoses: Change in number of cancer diagnoses reported by participants;Cancer surveillance: Change in number of MRIs and mammograms reported by participants;Breast cancer risk factors and genetics knowledge index;Brief COPE;Decision regret;Decision conflict: Change in decision conflict for untested relatives