Contact information
Type
Scientific
Primary contact
Dr Brenda Wilson
ORCID ID
Contact details
Department of Epidemiology & Community Medicine
University of Ottawa
451 Smyth Road
Ottawa
Ontario
K1H 8M5
Canada
+1 613 562 5800 x8261
bwilson@uottawa.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 94/14/20
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/02/1998
Overall trial end date
31/08/2002
Reason abandoned
Eligibility
Participant inclusion criteria
Women with familial breast cancer in need of genetic counselling
Participant type
Patient
Age group
Not Specified
Gender
Female
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/02/1998
Recruitment end date
31/08/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Epidemiology & Community Medicine
Ontario
K1H 8M5
Canada
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (UK)
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
1. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15694064
Publication citations
-
Results
Wilson BJ, Torrance N, Mollison J, Wordsworth S, Gray JR, Haites NE, Grant A, Campbell MK, Miedyzbrodzka Z, Clarke A, Watson MS, Douglas A, Improving the referral process for familial breast cancer genetic counselling: findings of three randomised controlled trials of two interventions., Health Technol Assess, 2005, 9, 3, iii-iv, 1-126.