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RCT in breast cancer genetic counselling.


- candidate number2411
- NTR NumberNTR887
- ISRCTNISRCTN82643064
- Date ISRCTN created26-feb-2007
- date ISRCTN requested21-feb-2007
- Date Registered NTR18-jan-2007
- Secondary IDsN/A 
- Public TitleRCT in breast cancer genetic counselling.
- Scientific TitleWeb-based tailored information and question prompt for enhancing counselee participation and outcome; a RCT in breast cancer genetic counselling.
- ACRONYMRCT in breast cancer genetic counselling
- hypothesisIn 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 personalize 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 which 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.
- Healt Condition(s) or Problem(s) studiedBreast cancer, Genetic counseling, Web-based tailored , Communication
- Inclusion criteria1.Counselee for breast cancer genetic counselling;
2. Age 18 or older;
3. Female gender;
4. Having internet access at home.
- Exclusion criteria1. Age under 18;
2. Male gender;
3. Not having internet access at home.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2007
- planned closingdate31-dec-2010
- Target number of participants200
- InterventionsThe information on the website (E-info geneca) is tailored to counselees' personal situation as guided by their answers on our previously developed 'QUOTE geneca' 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. E-info geneca will be developed by a multi-disciplinary team of genetic counsellors, psychologists, counselees and their relatives and using recent brochures of the Dutch Cancer Society.
- Primary outcomeCounselees' participation, i.e. content and amount of questions asked and information received during the visit.
- Secondary outcome1. Realistic expectations;
2. Information recall;
3. Need fulfilment;
4. Satisfaction;
5. Pre-post changes in breast cancer knowledge;
6. Risk perception;
7. Personal control;
8. Cancer worry;
9. (Intended) adherence to screening advices or prophylactic surgery at 12 months;
10. Satisfaction with e-info gene;
11. Anxiety.
- Timepoints1. One week before the first consultation for breast cancer genetic counselling;
2. After accessing the website E-info gene(ca) (only for the intervention group);
3. One week after the first consultation for breast cancer genetic counselling;
4. One week after the second consultation for breast cancer genetic counselling (if there is a second consultation);
5. One week after the third consultation for breast cancer genetic counselling (in case there is a third consultation);
6. One year after the final consultation for breast cancer genetic counselling.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. A. Albada
- CONTACT for SCIENTIFIC QUERIESProf. dr. S. Dulmen, van
- Sponsor/Initiator Nederlands instituut voor onderzoek van de gezondheidszorg (NIVEL), University Medical Centre Utrecht (UMCU), Department of Medical Genetics
- Funding
(Source(s) of Monetary or Material Support)
Dutch Cancer Society
- PublicationsAlbada A, Van Dulmen S, Ausems MGEM, Bensing JM. A pre-visit website with question prompt sheet for counselees facilitates communication in the first consultation for breast cancer genetic counselling: findings from an RCT. Genetics in Medicine. 2012;14(5):535-542.
Albada A, Van Dulmen S, Bensing JM, Ausems MGEM. A pre-visit tailored website enhances counselees’ realistic expectations and knowledge and decreases information needs for breast cancer genetic counseling. Familial Cancer. 2012;1:85-95.
Albada A, Ausems MGEM, Otten R, Bensing JM, Van Dulmen S. Use and evaluation of an individually tailored website for counselees prior to breast cancer genetic counseling. Journal of Cancer Education. 2011;26(4):670-681.
Albada A, Van Dulmen S, Otten R, Bensing JM, Ausems MGEM. Development of E-info geneca: A website providing computer-tailored information and question prompt prior to breast cancer genetic counseling. Journal of Genetic Counseling. 2009;18:326–338.
- Brief summaryThis study aims to establish the effectiveness of web-based counselee-tailored information plus question prompt designed to 1) increase realistic expectations of breast cancer genetic counselling, 2) facilitate participation, question asking and information exchange, 3) improve outcome by decreasing cancer worry and increasing knowledge, correct risk perception, personal control and 4) improve adherence to advices. To determine the effectiveness of the web-based intervention on counselling process and outcome, a randomised controlled trial, is conducted. 200 counselees referred for breast cancer to the Department of Medical Genetics of University Medical Centre Utrecht and having internet access at home will be included. Counselees will be randomly assigned to standard information (currently distributed leaflet) or web-based tailored information including question prompt and counsellor review (E-info geneca). All information is given at least 72 hours before the initial visit. Three questionnaires will be sent to the counselee. One before the initial visit, one after the initial visit and the last 12 months after the initial genetic counselling visit. These questionnaires measure breast cancer knowledge, risk perception, cancer worry and locus of control. Additionally the first questionnaire asks for expectations of the initial visit and the last two questionnaires measure information recall. The second questionnaire also measures satisfaction with the e-info gene. The visits will be videotaped and analysed on level of counselee participation.
- Main changes (audit trail)
- RECORD18-jan-2007 - 6-okt-2012


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