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Research project Direct Information to At-risk Relatives - a Randomized Controlled Multicentre Trial of Healthcare-assisted Versus Family-mediated Disclosure of Hereditary Cancer Risk Information in High-risk Families in Sweden
Inherited genetic changes make some families more susceptible to cancers than others. If such changes are found and identified, the inherited risk can be addressed by targeted surveillance or preventive surgery. To enable preventive efforts at-risk relatives need to be informed. This study will evaluate if healthcare-assisted disclosure of genetic risk information can affect the number of at-risk relatives approaching a cancer genetic unit for counselling within a year after their investigation. Our goal is to develop clinical practices which can reduce numbers of cancer cases in Sweden.
Targeted surveillance of at-risk relatives in families with confirmed hereditary cancer is a proven effective method for cancer prevention. Current clinical practice in Sweden, and most other countries, is that patients are asked to inform relatives (about results of a cancer genetic investigation) by themselves.
Unfortunately, this type of family-mediated disclosure is not very effective. Less than half of at-risk relatives actually receive information, refusing them the possibility to make informed decisions about their own health and well-being.
This study will evaluate two alternative protocols for disclosure of genetic information in high-risk families. We will investigate effectiveness and acceptance of a proactive approach where the patient is offered a healthcare-assisted disclosure procedure, and compare it with the standard family-mediated disclosure routine.
The research aims of our study is…
1. To assess whether an intervention with direct letters addressed to at-risk relatives impacts on the proportion of at-risk relatives approaching a Swedish cancer genetics unit within 12 months, as compared with standard family-mediated disclosure.
2. To explore safety and emotional responses in at-risk relatives when receiving direct letters about hereditary health risks and preventive measures.
3. To explore attitudes towards the offer of assisted disclosure with direct letters among probands undergoing a cancer genetic investigation.
The study’s main component is a randomized controlled trial (RCT) featuring an offer of mailed letters directly to at-risk relatives. It will be conducted at four Swedish cancer genetics units involving 600 families with increased risk of developing breast, ovarian or colorectal cancer.
Besides the described intervention, a mixed method follow-up study will measure qualitative and quantitative outcomes during the intervention process. This parallel study will employ data sources that include questionnaires and in-depth interviews.