Cluster randomised controlled trial of computer decision support for management of familial cancer in primary care
| ISRCTN | ISRCTN71084565 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71084565 |
| Secondary identifying numbers | N/A |
- Submission date
- 16/10/2002
- Registration date
- 16/10/2002
- Last edited
- 08/10/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Helen Morris
Scientific
Scientific
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
| Phone | +44 (0)1223 330323 |
|---|---|
| hcm29@medschl.cam.ac.uk |
Study information
| Study design | Cluster randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Diagnostic |
| Scientific title | |
| Study acronym | GRAIDS Trial |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/04/2002 |
| Completion date | 30/09/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 1300 |
| Key inclusion criteria | Patients approaching their General Prectitioner (GP) or practice nurse with concerns about their family history of cancer. |
| Key exclusion criteria | 1. Children under 18 2. People with learning difficulties 3. Severely ill 4. Other vulnerable groups e.g. mental illness, dementia |
| Date of first enrolment | 01/04/2002 |
| Date of final enrolment | 30/09/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
GRAIDS Trial Coordinator
Cambridge
CB2 2SR
United Kingdom
CB2 2SR
United Kingdom
Sponsor information
Cancer Research UK (UK)
Charity
Charity
P.O. Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
| Website | http://www.cancer.org.uk |
|---|---|
"ROR" |
https://ror.org/054225q67 |
Funders
Funder type
Charity
Cancer Research UK (CRUK) (UK)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 20/08/2007 | Yes | No |
