Contact information
Type
Scientific
Primary contact
Dr Helen Morris
ORCID ID
Contact details
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
Cambridge
CB2 2SR
United Kingdom
+44 (0)1223 330323
hcm29@medschl.cam.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
GRAIDS Trial
Study hypothesis
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.
Ethics approval
Not provided at time of registration
Study design
Cluster randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Diagnostic
Patient information sheet
Condition
Familial breast or colorectal cancer
Intervention
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
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
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
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/04/2002
Overall trial end date
30/09/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients approaching their General Prectitioner (GP) or practice nurse with concerns about their family history of cancer.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1300
Participant exclusion criteria
1. Children under 18
2. People with learning difficulties
3. Severely ill
4. Other vulnerable groups e.g. mental illness, dementia
Recruitment start date
01/04/2002
Recruitment end date
30/09/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
GRAIDS Trial Coordinator
Cambridge
CB2 2SR
United Kingdom
Sponsor information
Organisation
Cancer Research UK (UK)
Sponsor details
P.O. Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (CRUK) (UK)
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
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
Basic results (scientific)
Publication list
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17700548
Publication citations
-
Results
Emery J, Morris H, Goodchild R, Fanshawe T, Prevost AT, Bobrow M, Kinmonth AL, The GRAIDS Trial: a cluster randomised controlled trial of computer decision support for the management of familial cancer risk in primary care., Br. J. Cancer, 2007, 97, 4, 486-493, doi: 10.1038/sj.bjc.6603897.