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
Secondary identifying numbers	KWF number: VU 2004-2994; NTR89

Submission date: 12/09/2005
Registration date: 12/09/2005
Last edited: 07/05/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Dr D R M Timmermans
Scientific

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

Study information

Study design	Randomised, active controlled, parallel group, double-blinded trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Quality of life
Scientific title
Study acronym	BRISC
Study hypothesis	Not provided at time of registration
Ethics approval(s)	Ethics approval received from the local medical ethics committee
Condition	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	Adequate risk perception
Secondary outcome measures	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
Overall study start date	15/07/2004
Overall study end date	15/07/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	300
Participant 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.
Participant 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
Recruitment start date	15/07/2004
Recruitment end date	15/07/2008

Locations

Countries of recruitment

Netherlands

Study participating centre

VU Medisch Centrum

Amsterdam
1081 B
Netherlands

Sponsor information

VU University Medical Centre/EMGO-Institute (The Netherlands)
Hospital/treatment centre

Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Phone	+31 (0)20 444 8180
Email	emgo@vumc.nl
Website	http://www.vumc.nl/
"ROR"	https://ror.org/00q6h8f30

Funders

Funder type

Charity

Dutch Cancer Society (KWF Kankerbestrijding) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

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