Condition category
Cancer
Date applied
26/02/2007
Date assigned
26/02/2007
Last edited
31/10/2012
Prospective/Retrospective
Prospectively 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 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

http://www.nivel.nl/

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

Publication citations

Additional files

Editorial Notes