Communicating breast cancer risks: a genetic counsellor's role in improving patient understanding to increase informed decision-making

ISRCTN	ISRCTN14566836
DOI	https://doi.org/10.1186/ISRCTN14566836
Protocol serial number	KWF number: VU 2004-2994; NTR89
Sponsor	VU University Medical Centre/EMGO-Institute (The Netherlands)
Funder	Dutch Cancer Society (KWF Kankerbestrijding) (The Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr D R M Timmermans
Scientific

VU Medisch Centrum
Afd Sociale Geneeskunde
Van der Boechorststraat 7
Amsterdam
1081 B
Netherlands

Primary study design	Interventional
Study design	Randomised, active controlled, parallel group, double-blinded trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	BRISC
Study objectives	Not provided at time of registration
Ethics approval(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	Mammary carcinoma
Intervention	The intervention-additional risk information is given to healthy women with a family history of breast cancer immediately after standard counselling with the clinical geneticist. The intervention consists of one of five conditions that differ in the way risk is communicated, that is: 1. Life-time breast cancer risk in a numerical format 2. Life-time breast cancer risk in a numerical and graphical format 3. Both life-time risk and age-related breast cancer risk in a numerical format 4. Both life-time risk and age-related breast cancer risk in a numerical and graphical format 5. Control group
Intervention type	Other
Primary outcome measure(s)	Adequate risk perception
Key secondary outcome measure(s)	1. Cognitive evaluation (knowledge about hereditary breast cancer, informed decisions) 2. Psychological and affective evaluation ([cancer] anxiety, worry) 3. Evaluation of perceived benefits and helpfulness of the additional risk counselling 4. Expected intention or actual uptake of methods of breast cancer detection and prevention
Completion date	15/07/2008

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	300
Key inclusion criteria	A consecutive series of women who are first time attenders applying for genetic breast cancer counselling at three Dutch Clinical Genetic Centres (VUmc Amsterdam, LUMC Leiden and UMCG Groningen) are invited to participate in the study.
Key exclusion criteria	Women are considered ineligible if they are: 1. Less than 18 years of age 2. Have evident psychiatric illness 3. Have a terminal disease 4. Women with a personal history of breast or ovarian cancer
Date of first enrolment	15/07/2004
Date of final enrolment	15/07/2008

VU Medisch Centrum

Amsterdam
1081 B
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	29/04/2013		Yes	No
Protocol article	study protocol	03/10/2008		Yes	No