Improving communication during recruitment to clinical trials of cancer therapy
| ISRCTN | ISRCTN31282696 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31282696 |
| Secondary identifying numbers | NCP/D21 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 23/05/2012
- 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
Prof Lesley Fallowfield
Scientific
Scientific
CRC Psychosocial Oncology Group
Dept of Oncology
Royal Free & University College Medical School
UCL
48 Riding House Street
London
W1P 7PL
United Kingdom
| Phone | +44 (0)20 7679 9203 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | Added 06/08/09: Specific details about an individual patient's attitudes to clinical trials will be elicited so that the development and validation of the questionnaire will be completed. When the instrument has been refined satisfactorily it is hoped that clinicians will be provided with an easy means of identifying the potential areas of difficulty that individual patients might have with the concentp of trials and/or randomisation. As of 06/08/09 this record has been extensively updated. All updates can be found under the relavent field with the above update date. Please also note that the start and end dates of this trial have been changed from 01/01/99 and 31/01/99 to 18/10/96 and 25/02/97, respectively. The initial dates were generated by the system. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Miscellaneous cancers |
| Intervention | 1. Standardised trial consent procedure. 2. Individualised trial consent procedure using a 'Profile of Patient Preferences'. |
| Intervention type | Other |
| Primary outcome measure | Added 06/08/09: Quality of life |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 18/10/1996 |
| Completion date | 25/02/1997 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Patients aged over 16 with cancer; medical, clinical and surgical oncologists. |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 18/10/1996 |
| Date of final enrolment | 25/02/1997 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
CRC Psychosocial Oncology Group
London
W1P 7PL
United Kingdom
W1P 7PL
United Kingdom
Sponsor information
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
NHS Cancer National Research and Development Programme (UK)
No information available
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 | 01/02/2001 | Yes | No |
