Improving the referral process for familial breast cancer genetic counselling: an evaluation of complementary interventions
| ISRCTN | ISRCTN60569158 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN60569158 |
| Protocol serial number | HTA 94/14/20 |
| Sponsor | Department of Health (UK) |
| Funder | NIHR Health Technology Assessment Programme - HTA (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/08/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| 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
- United Kingdom
- Canada
Study participating centre
Department of Epidemiology & Community Medicine
Ontario
K1H 8M5
Canada
K1H 8M5
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
