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

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 designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeQuality 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 objectivesAdded 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) studiedMiscellaneous cancers
Intervention1. Standardised trial consent procedure.
2. Individualised trial consent procedure using a 'Profile of Patient Preferences'.
Intervention typeOther
Primary outcome measureAdded 06/08/09:
Quality of life
Secondary outcome measuresNot provided at time of registration
Overall study start date18/10/1996
Completion date25/02/1997

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsNot provided at time of registration
Key inclusion criteriaPatients aged over 16 with cancer; medical, clinical and surgical oncologists.
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment18/10/1996
Date of final enrolment25/02/1997

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

CRC Psychosocial Oncology Group
London
W1P 7PL
United Kingdom

Sponsor information

Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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