Randomised controlled trial in breast cancer genetic counseling

ISRCTN ISRCTN82643064
DOI https://doi.org/10.1186/ISRCTN82643064
Secondary identifying numbers N/A
Submission date
26/02/2007
Registration date
26/02/2007
Last edited
05/01/2021
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 of protocol

Not provided at time of registration

Contact information

Dr A Albada
Scientific

Netherlands Institute for Health Services Research (NIVEL)
P.O. Box 1568
Utrecht
3500 BN
Netherlands

Phone (+31) (0)30 272 9700
Email a.albada@nivel.nl

Study information

Study designRandomised, active controlled, parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeQuality of life
Scientific titleRandomised controlled trial in breast cancer genetic counseling
Study objectivesIn 2003 over 35% of counselees at Dutch clinical genetic centres were referred because of cancer, 90% of which concerns breast cancer. At least 5% of all breast cancer is considered hereditary. The goal of counselling is to personalise technical and probabilistic genetic information to enable well-informed decisions. Yet, our previous study in 130 initial cancer genetic counselling visits showed that the information provided is relatively standard. More tailored and psychosocially oriented information is not given routinely unless counselees request it specifically.

Our study also showed that many counselees are dissatisfied with the way emotional matters are discussed and that dissatisfaction leads to experiencing less personal control and more anxiety. This may influence adherence to screening advices negatively. As many counselees do not know what to expect from genetic counselling, they may be unable to formulate specific questions and needs on medical, psychosocial and emotional issues. To improve outcome, counselees should be specifically prepared and encouraged to formulate and disclose questions and concerns.

For this purpose, a preparatory web-based intervention for increasing counselee question asking and participation might be feasible, attractive and easy to implement. The web-based information will include different levels of up-to-date genetic and psychosocial information that can be viewed as needed, and a question prompt sheet. Analysis of counselees' searching behaviour (page-views, time online) will reveal what information is retrieved and favoured most. To increase the impact of the intervention, counsellors are instructed to review the prompted questions before the visit.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedGenetic counseling, web-based tailored info, communication, breast cancer
InterventionThe information on the website (e-info) is tailored to counselees' personal situation as guided by their answers on our previously developed 'QUOTE gene ca' scale. This produces different packages of pre-visit information in content, extensiveness and complexity and may generate a variety of questions to be dealt with in the subsequent visit.

The e-info gene will be developed by a multi-disciplinary team of genetic counsellors, psychologists, counselees and their relatives and using recent Dutch Cancer Society (KWF) brochures.
Intervention typeOther
Primary outcome measureCounselees' participation, i.e. content and amount of questions asked and information received during the visit.
Secondary outcome measures1. Effects on expectations
1. Information recall
2. Need fulfillment
3. Satisfaction
4. Pre-post changes in breast cancer knowledge
5. Risk perception
6. Personal control
7. Cancer worry
8. (Intended) adherence to screening advices or prophylactic surgery at 12 months
9. Satisfaction with e-info gene
Overall study start date01/09/2007
Completion date31/12/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants200
Total final enrolment197
Key inclusion criteria1.Counselee for breast cancer genetic counseling
2. Age 18 or older
3. Female gender
4. Having internet access at home
Key exclusion criteria1. Age under 18
2. Male gender
3. Not having internet access at home
Date of first enrolment01/09/2007
Date of final enrolment31/12/2010

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Netherlands Institute for Health Services Research (NIVEL)
Utrecht
3500 BN
Netherlands

Sponsor information

Netherlands Institute for Health Services Research (NIVEL) (The Netherlands)
Research organisation

P.O. Box 1568
Utrecht
3500 BN
Netherlands

Phone +31 (0)30 272 9700
Email receptie@nivel.nl
Website http://www.nivel.nl/
ROR logo "ROR" https://ror.org/015xq7480

Funders

Funder type

Charity

Dutch Cancer Society (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Other publications retraction 31/10/2012 05/01/2021 Yes No
Results article results 06/03/2012 05/01/2021 Yes No

Editorial Notes

05/01/2021: Publication references and total final enrolment added.