Condition category
Cancer
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
30/05/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dh.gov.uk/en/index.htm

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

  1. 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.

Additional files

Editorial Notes