Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NCP/D21
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Miscellaneous cancers
Intervention
1. Standardised trial consent procedure.
2. Individualised trial consent procedure using a 'Profile of Patient Preferences'.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Added 06/08/09:
Quality of life
Secondary outcome measures
Not provided at time of registration
Overall trial start date
18/10/1996
Overall trial end date
25/02/1997
Reason abandoned
Eligibility
Participant inclusion criteria
Patients aged over 16 with cancer; medical, clinical and surgical oncologists.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
18/10/1996
Recruitment end date
25/02/1997
Locations
Countries of recruitment
United Kingdom
Trial participating centre
CRC Psychosocial Oncology Group
London
W1P 7PL
United Kingdom
Sponsor information
Organisation
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Cancer National Research and Development Programme (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
2001 results on http://www.ncbi.nlm.nih.gov/pubmed/11239753
Publication citations
-
Results
Fleissig A, Jenkins V, Fallowfield L, Results of an intervention study to improve communication about randomised clinical trials of cancer therapy., Eur. J. Cancer, 2001, 37, 3, 322-331.