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ISRCTN
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ISRCTN60569158
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ClinicalTrials.gov identifier
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Public title
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Improving the referral process for familial breast cancer genetic counselling: an evaluation of complementary interventions
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Scientific title
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Acronym
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N/A
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Serial number at source
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HTA 94/14/20
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Cancer (neoplasms): Breast
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Participants - inclusion criteria
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Women with familial breast cancer in need of genetic counselling
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/02/1998
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Anticipated end date
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31/08/2002
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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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
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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Publications
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1. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15694064
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Contact name
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Dr
Brenda
Wilson
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Address
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Department of Epidemiology & Community Medicine
University of Ottawa
451 Smyth Road
Ottawa
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City/town
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Ontario
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Zip/Postcode
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K1H 8M5
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Country
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Canada
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Tel
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+1 613 562 5800 x8261
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Fax
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+1 613 562 5645
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Email
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bwilson@uottawa.ca
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Sponsor
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Department of Health (UK)
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Address
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Quarry House
Quarry Hill
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City/town
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Leeds
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Zip/Postcode
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LS2 7UE
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Country
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United Kingdom
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Tel
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+44 (0)1132 545 843
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Email
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Sheila.Greener@doh.gsi.gov.uk
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Sponsor website:
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http://www.dh.gov.uk/en/index.htm
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Date applied
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25/04/2003
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Last edited
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27/10/2010
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Date ISRCTN assigned
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25/04/2003
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