Ockhuysen‐Vermey 2008.

Study name	Design of the BRISC study: a multi‐centre controlled clinical trial to optimise the communication of breast cancer risks in genetic counselling
Methods	The BRISC study is designed as a pre‐post‐test controlled group intervention trial with repeated measurements using questionnaires
Participants	Women with a family history of breast cancer who are first‐time attendees applying for breast cancer counselling are invited to participate in the study. A family history of breast cancer is defined as having or having had at least one first‐degree‐ and/or paternal second‐degree family member with breast cancer. Women are considered ineligible if they are under 18 years of age, have evident psychiatric illness or terminal disease, and are unable to read and write Dutch. Women with a personal history of breast or ovarian cancer are also excluded
Interventions	One additional consultation by a trained "risk counsellor" immediately after a standard genetic counselling session. During the additional consultation, risks are communicated in one of five ways (conditions): 1) lifetime breast cancer risk in numerical format (in natural frequencies, i.e. X out of 100), 2) lifetime breast cancer risk in both numerical format and graphical format (i.e. population figures in 10 rows of 10) 3) lifetime breast cancer risk and age‐related breast cancer risk in numerical format, 4) lifetime breast cancer risk and age‐related breast cancer risk in both numerical format and graphical format, and 5) lifetime breast cancer risk in percentages
Outcomes	Cognitive outcomes, psychological well‐being, decision‐making, evaluation of the intervention
Starting date	Protocol approved in 2005
Contact information	Caroline F Ockhuysen‐Vermey: karen.ockhuysen@hotmail.com
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