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Communicating breast cancer risks: a genetic counsellor's role in improving patient understanding to increase informed decision-making
ISRCTN ISRCTN14566836
DOI 10.1186/ISRCTN14566836
ClinicalTrials.gov identifier
EudraCT number
Public title Communicating breast cancer risks: a genetic counsellor's role in improving patient understanding to increase informed decision-making
Scientific title
Acronym BRISC
Serial number at source KWF number: VU 2004-2994; NTR89
Study hypothesis Not provided at time of registration
Lay summary Not provided at time of registration
Ethics approval Ethics approval received from the local medical ethics committee
Study design Randomised, active controlled, parallel group, double-blinded trial
Countries of recruitment Netherlands
Disease/condition/study domain Mammary carcinoma
Participants - 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.
Participants - 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
Anticipated start date 15/07/2004
Anticipated end date 15/07/2008
Status of trial Completed
Patient information material
Target number of participants 300
Interventions 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
Primary outcome measure(s) Adequate risk perception
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
Sources of funding Dutch Cancer Society (KWF Kankerbestrijding) (The Netherlands)
Trial website
Publications 1. 2008 study protocol in http://www.ncbi.nlm.nih.gov/pubmed/18834503
2. 2013 results in www.ncbi.nlm.nih.gov/pubmed/23627498
Contact name Dr  D R M  Timmermans
  Address VU Medisch Centrum
Afd Sociale Geneeskunde
Van der Boechorststraat 7
  City/town Amsterdam
  Zip/Postcode 1081 B
  Country Netherlands
Sponsor VU University Medical Centre/EMGO-Institute (The Netherlands)
  Address Van der Boechorststraat 7
  City/town Amsterdam
  Zip/Postcode 1081 BT
  Country Netherlands
  Tel +31 (0)20 444 8180
  Fax +31 (0)20 444 8181
  Email emgo@vumc.nl
  Sponsor website: http://www.vumc.nl/
Date applied 12/09/2005
Last edited 07/05/2013
Date ISRCTN assigned 12/09/2005
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