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
Scientific
Netherlands Institute for Health Services Research (NIVEL)
P.O. Box 1568
Utrecht
3500 BN
Netherlands
| Phone | (+31) (0)30 272 9700 |
|---|---|
| a.albada@nivel.nl |
Study information
| Study design | Randomised, active controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Scientific title | Randomised controlled trial in breast cancer genetic counseling |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/09/2007 |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 200 |
| Total final enrolment | 197 |
| Key inclusion criteria | 1.Counselee for breast cancer genetic counseling 2. Age 18 or older 3. Female gender 4. Having internet access at home |
| Key exclusion criteria | 1. Age under 18 2. Male gender 3. Not having internet access at home |
| Date of first enrolment | 01/09/2007 |
| Date of final enrolment | 31/12/2010 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Netherlands Institute for Health Services Research (NIVEL)
Utrecht
3500 BN
Netherlands
3500 BN
Netherlands
Sponsor information
Netherlands Institute for Health Services Research (NIVEL) (The Netherlands)
Research organisation
Research organisation
P.O. Box 1568
Utrecht
3500 BN
Netherlands
| Phone | +31 (0)30 272 9700 |
|---|---|
| receptie@nivel.nl | |
| Website | http://www.nivel.nl/ |
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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.
