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


- candidate number0
- NTR NumberNTR89
- ISRCTNISRCTN14566836
- Date ISRCTN created12-sep-2005
- date ISRCTN requested18-aug-2005
- Date Registered NTR15-jul-2005
- Secondary IDsKWF number: VU 2004-2994 
- Public TitleCommunicating breast cancer risks: a genetic counsellor's role in improving patient understanding to increase informed decision-making.
- Scientific TitleCommunicating breast cancer risks: a genetic counsellor's role in improving patient understanding to increase informed decision-making.
- ACRONYMBRISC
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedMamma carcinoma
- Inclusion criteriaA 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.
- Exclusion criteriaWomen are considered ineligible if they are
< 18 years of age,
have evident psychiatric illness,
have a terminal disease,
women with a personal history of breast or ovarian cancer.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 15-jul-2004
- planned closingdate15-jul-2008
- Target number of participants300
- InterventionsThe 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 consitions 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 outcomeAdequate riskperception.
- Secondary outcome1. 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.
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. D.R.M. Timmermans
- CONTACT for SCIENTIFIC QUERIESDr. D.R.M. Timmermans
- Sponsor/Initiator VU University Medical Center, EMGO+ Institute
- Funding
(Source(s) of Monetary or Material Support)
Dutch Cancer Society
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD17-aug-2005 - 12-dec-2006


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