Condition category
Cancer
Date applied
12/09/2005
Date assigned
12/09/2005
Last edited
07/05/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr D R M Timmermans

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

KWF number: VU 2004-2994; NTR89

Study information

Scientific title

Acronym

BRISC

Study hypothesis

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

15/07/2004

Overall trial end date

15/07/2008

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Female

Target number of participants

300

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

Trial participating centre

VU Medisch Centrum
Amsterdam
1081 B
Netherlands

Sponsor information

Organisation

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

Sponsor details

Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
+31 (0)20 444 8180
emgo@vumc.nl

Sponsor type

Hospital/treatment centre

Website

http://www.vumc.nl/

Funders

Funder type

Charity

Funder name

Dutch Cancer Society (KWF Kankerbestrijding) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2008 study protocol in http://www.ncbi.nlm.nih.gov/pubmed/18834503
2. 2013 results in www.ncbi.nlm.nih.gov/pubmed/23627498

Publication citations

  1. Study protocol

    Ockhuysen-Vermey CF, Henneman L, van Asperen CJ, Oosterwijk JC, Menko FH, Timmermans DR, Design of the BRISC study: a multicentre controlled clinical trial to optimize the communication of breast cancer risks in genetic counselling., BMC Cancer, 2008, 8, 283, doi: 10.1186/1471-2407-8-283.

  2. Results

    Henneman L, Oosterwijk JC, van Asperen CJ, Menko FH, Ockhuysen-Vermey CF, Kostense PJ, Claassen L, Timmermans DR, The effectiveness of a graphical presentation in addition to a frequency format in the context of familial breast cancer risk communication: a multicenter controlled trial., BMC Med Inform Decis Mak, 2013, 13, 55, doi: 10.1186/1472-6947-13-55.

Additional files

Editorial Notes