Condition category
Cancer
Date applied
16/10/2002
Date assigned
16/10/2002
Last edited
08/10/2012
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 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 measures

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

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

http://www.cancer.org.uk

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

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

Results - basic reporting

Publication summary

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17700548

Publication citations

  1. 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.

Additional files

Editorial Notes