| - candidate number | 0 |
| - NTR Number | NTR89 |
| - ISRCTN | ISRCTN14566836 |
| - Date ISRCTN created | 12-sep-2005 |
| - date ISRCTN requested | 18-aug-2005 |
| - Date Registered NTR | 15-jul-2005 |
| - Secondary IDs | KWF number: VU 2004-2994 |
| - Public Title | Communicating breast cancer risks: a genetic counsellor's role in improving patient understanding to increase informed decision-making. |
| - Scientific Title | Communicating breast cancer risks: a genetic counsellor's role in improving patient understanding to increase informed decision-making. |
| - ACRONYM | BRISC |
| - hypothesis | N/A |
| - Healt Condition(s) or Problem(s) studied | Mamma carcinoma |
| - 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. |
| - Exclusion criteria | Women 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 received | yes |
| - multicenter trial | no |
| - randomised | yes |
| - masking/blinding | Double |
| - control | Active |
| - group | Parallel |
| - Type | - |
| - Studytype | intervention |
| - planned startdate | 15-jul-2004 |
| - planned closingdate | 15-jul-2008 |
| - 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 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 outcome | Adequate riskperception. |
| - Secondary outcome | 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. |
| - Timepoints | |
| - Trial web site | N/A |
| - status | open: patient inclusion |
| - CONTACT FOR PUBLIC QUERIES | Dr. D.R.M. Timmermans |
| - CONTACT for SCIENTIFIC QUERIES | Dr. D.R.M. Timmermans |
| - Sponsor/Initiator | VU University Medical Center, EMGO-Institute |
| - Funding (Source(s) of Monetary or Material Support) | Dutch Cancer Society |
| - Publications | N/A |
| - Brief summary | N/A |
| - Main changes (audit trail) | |
| - RECORD | 17-aug-2005 - 12-dec-2006 |
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