Improving the referral process for familial breast cancer genetic counselling: an evaluation of complementary interventions
| ISRCTN | ISRCTN60569158 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN60569158 |
| Secondary identifying numbers | HTA 94/14/20 |
- Submission date
- 25/04/2003
- Registration date
- 25/04/2003
- Last edited
- 30/05/2012
- 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 Brenda Wilson
Scientific
Scientific
Department of Epidemiology & Community Medicine
University of Ottawa
451 Smyth Road
Ottawa
Ontario
K1H 8M5
Canada
| Phone | +1 613 562 5800 x8261 |
|---|---|
| bwilson@uottawa.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | The NHS needs to identify cost-effective approaches to managing the increased demand for genetic counselling for familial cancers, particularly in the primary care setting. Using familial breast cancer as a model, this study aims to evaluate two separate, but complementary, interventions using randomised controlled trials: the first designed to improve the process of deciding to refer from primary care to specialist services, the second to cope with referred women in a cost-effective way in the community. In the first trial, general practices in Grampian will be randomised to receive specific educational input for a member of their staff, along with specific decision-support software, or to no intervention (control): outcomes will relate to appropriateness of referrals and patient understanding, In the second trial, based in Grampian and Wales, referred women will be randomised either to see a community-based genetics outreach nurse or to the current, specialist service: comparisons will be made of psychological outcomes and retention of risk information, and service acceptability to patients and professionals. An economic evaluation is an integral component of each trial. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cancer (neoplasms): Breast |
| Intervention | Trial 1: 1. Receive specific educational input for a member of their staff, along with specific decision-support software 2. Standard care. Trial 2: Referred women will be randomised to see 1. A community-based genetics outreach nurse 2. Remain on current specialist service |
| Intervention type | Other |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/02/1998 |
| Completion date | 31/08/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Women with familial breast cancer in need of genetic counselling |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/02/1998 |
| Date of final enrolment | 31/08/2002 |
Locations
Countries of recruitment
- Canada
- United Kingdom
Study participating centre
Department of Epidemiology & Community Medicine
Ontario
K1H 8M5
Canada
K1H 8M5
Canada
Sponsor information
Department of Health (UK)
Government
Government
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
| Phone | +44 (0)1132 545 843 |
|---|---|
| Sheila.Greener@doh.gsi.gov.uk | |
| Website | http://www.dh.gov.uk/en/index.htm |
"ROR" |
https://ror.org/03sbpja79 |
Funders
Funder type
Government
NIHR Health Technology Assessment Programme - HTA (UK)
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? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2005 | Yes | No |
