Contact information
Type
Scientific
Primary contact
Dr A Albada
ORCID ID
Contact details
Netherlands Institute for Health Services Research (NIVEL)
P.O. Box 1568
Utrecht
3500 BN
Netherlands
(+31) (0)30 272 9700
a.albada@nivel.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
In 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
Not provided at time of registration
Study design
Randomised, active controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Condition
Genetic counseling, web-based tailored info, communication, breast cancer
Intervention
The 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 type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Counselees' participation, i.e. content and amount of questions asked and information received during the visit.
Secondary outcome measures
1. 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 trial start date
01/09/2007
Overall trial end date
31/12/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1.Counselee for breast cancer genetic counseling
2. Age 18 or older
3. Female gender
4. Having internet access at home
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
200
Participant exclusion criteria
1. Age under 18
2. Male gender
3. Not having internet access at home
Recruitment start date
01/09/2007
Recruitment end date
31/12/2010
Locations
Countries of recruitment
Netherlands
Trial participating centre
Netherlands Institute for Health Services Research (NIVEL)
Utrecht
3500 BN
Netherlands
Sponsor information
Organisation
Netherlands Institute for Health Services Research (NIVEL) (The Netherlands)
Sponsor details
P.O. Box 1568
Utrecht
3500 BN
Netherlands
+31 (0)30 272 9700
receptie@nivel.nl
Sponsor type
Research organisation
Website
Funders
Funder type
Charity
Funder name
Dutch Cancer Society (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