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ISRCTN
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ISRCTN71084565
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ClinicalTrials.gov identifier
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Public title
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Cluster randomised controlled trial of computer decision support for management of familial cancer in primary care
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Scientific title
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Acronym
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GRAIDS Trial
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Serial number at source
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N/A
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Study hypothesis
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This project applies the Medical Research Council (MRC) framework for evaluation of complex interventions and encompasses an optimisation trial of computer decision support for familial cancer in primary care and an audit of current referral patterns for familial cancers to inform power calculations for a subsequent multi-centre trial. This optimisation trial will pilot procedures for the delivery and assessment of the intervention and will, in addition, seek to optimise and identify the most cost-effective intervention that should be evaluated in a full-scale trial by having a fixed and an adaptive intervention arm.
The underlying hypotheses are that the provision of computer decision support and a family history questionnaire in primary care will lead to more appropriate and cost-effective referrals for familial cancers (i.e. that are in line with regional referral criteria), and will enable patients to make better informed decisions about their familial risk of cancer.
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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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Familial breast or colorectal cancer
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Participants - inclusion criteria
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Patients approaching their General Prectitioner (GP) or practice nurse with concerns about their family history of cancer.
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Participants - exclusion criteria
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1. Children under 18
2. People with learning difficulties
3. Severely ill
4. Other vulnerable groups e.g. mental illness, dementia
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Anticipated start date
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01/04/2002
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Anticipated end date
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30/09/2005
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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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1300
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Interventions
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Intervention arm subjects:
Patients approaching their GP or practice nurse with concerns about their family history of cancer will be given a family history questionnaire to take home to complete, and then return for a second appointment. At the second consultation the trained lead clinician will enter information supplied by the patient and the family history questionnaire into the GRAIDS software. The software will support discussions with the patient about their risk of cancer and subsequent management.
Control arm subjects:
Subjects in the control practices approaching their GP or practice nurse with concerns about familial cancer will have a normal consultation according to their GPs current practice.
All subjects:
Subjects who are referred to the Regional Genetics Clinic will be asked to complete the measure of Informed Decision Making (IDM) questionnaire. This request will come from the Clinic with their appointment letter. The subjects will be requested to return the completed questionnaire to the Study Team.
Subjects in the intervention practices who are not referred to the Regional Genetics Clinic will be sent a measure of IDM questionnaire by the Study Team. Six months after they have returned the measure of IDM, the subjects will be sent a second measure of IDM to complete and return to the Study Team.
Trial Principal Investigator: Professor Jon Emery
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Primary outcome measure(s)
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1. The number of times that the GRAIDS software is used in the GP practices
2. The total number of referrals to secondary care about familial cancer and the proportion that meet regional referral criteria
3. The cost per use of the software and the cost per appropriate referral
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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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Cancer Research UK (UK)
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Trial website
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Publications
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Contact name
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Dr
Helen
Morris
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Address
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GRAIDS Trial Coordinator
General Practice & Primary Care Research Unit
Department of Public Health & Primary Care
University of Cambridge
Institute of Public Health
Forvie Site
Robinson Way
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City/town
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Cambridge
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Zip/Postcode
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CB2 2SR
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Country
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United Kingdom
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Tel
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+44 (0)1223 330323
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Fax
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+44 (0)1223 762515
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Email
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hcm29@medschl.cam.ac.uk
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Sponsor
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Cancer Research UK (UK)
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Address
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P.O. Box 123
Lincoln's Inn Fields
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City/town
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London
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Zip/Postcode
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WC2A 3PX
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Country
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United Kingdom
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Sponsor website:
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http://www.cancer.org.uk
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Date applied
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16/10/2002
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Last edited
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03/10/2006
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Date ISRCTN assigned
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16/10/2002
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