Condition category
Cancer
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
23/05/2012
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

Prof Lesley Fallowfield

ORCID ID

Contact details

CRC Psychosocial Oncology Group
Dept of Oncology
Royal Free & University College Medical School
UCL
48 Riding House Street
London
W1P 7PL
United Kingdom
+44 (0)20 7679 9203

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes