Condition category
Cancer
Date applied
13/03/2014
Date assigned
23/04/2014
Last edited
23/04/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Within the European Union (EU), pharmaceutical licence holders have to make public information on potential adverse effects associated with medicines. EU guidance is that this information should include estimated frequencies of any effects; however there is uncertainty about the most effective way to do this. In the UK two influential organisations, the MHRA and NICE, have advocated using risk expressions that combine a numerical estimator and a verbal term: eg "this side effect is common (it may affect more than 1 in 100 people. However there is no apparent evidence to support this recommendation and a concern is that the use of the verbal terms (very common, common, uncommon, rare, very rare) may lead to increased risk estimates. There is also a lack of evidence about the risk qualifier terms. In this case, the recommendation is to use the term 'may', although 'will' would seem more accurate. This study will allocate participants to receive information on 5 side effects of Taxol using either a numerical term only or a combined numerical and verbal term, and using either the word 'will' or the word 'may'.

Who can participate?
Adults accessing the study via two pages (http://www.cancerresearchuk.org/cancer-help/about-cancer/treatment/cancer-drugs/paclitaxel AND http://www.cancerresearchuk.org/cancer-help/about-cancer/treatment/cancer-drugs/) on the Cancer Help UK website.

What does the study involve?
Participants will read the information and then estimate the frequency of the 5 side effects and of any side effect occurring. They will also give estimates of the severity and 'harmfulness' of the side effects, using 5 Likert scales. Finally participants will complete 8 questions intended to measure their numeracy skills.

What are the possible benefits and risks of participating?
Potential benefits of participating are to have a clearer understanding of the risks associated with the medicine, Taxol. There are no risks associated with taking part - just the time given to completing the questionnaire.

Where is the study run from?
The study is the result of a collaboration between researchers at the Universities of York and Leeds, and the website Cancer Help UK (owned by the charity Cancer Research UK). The data are held on a database at the University of Leeds. The PI, Dr Peter Knapp, is based at the University of York, UK.

When is the study starting and how long is it expected to run for?
The study started to recruit participants in July 2012 and will run until April 2014.

Who is funding the study?
University of Leeds and University of York (UK)

Who is the main contact?
Peter Knapp
peter.knapp@york.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Peter Knapp

ORCID ID

Contact details

Department of Health Sciences
University of York
York
LS10 9DD
United Kingdom
+44 (0)1904 321675
peter.knapp@york.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

York-Leeds CRUK9

Study information

Scientific title

What is the effect of two framing variables on perceived risks associated with the medicine Taxol?

Acronym

CRUK9

Study hypothesis

That participants' risk perceptions will not be influenced by two potential framing influences: first, providing frequency information using numbers alone or a combination of number and words; second, using different verbal qualifiers to convey risk.

Ethics approval

University of Leeds, Institute of Psychological Sciences research Ethics Committee, 22nd June 2012, (Ref number 12-0127).

Study design

Factorial trial (2x2) with concealed random allocation of individual participants

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Screening

Patient information sheet

There is no PIS - that was approved by the REC. There is brief information on the website before people agree to take part. By agreeing to take part, people are confirming that they have received sufficient information about the study.

Condition

Cancer

Intervention

Information. (Risk frequency information presented in one of four ways).

There are four arms to the trial. Participants read the information about the medicines and then answer some questions about it. That is, 'follow-up' is immediate.
In all four arms of the trial participants receive information about 10 potential side effects of Taxol - the way that that risk is expressed varies across the four trial conditions.

The side effects:

1. May affect more than 1 in 10 people.
2. Very common: may affect more than 1 in 10 people
3. Will affect more than 1 in 10 people.
4. Very common: will affect more than 1 in 10 people.

(The incident rate bands vary according to the SE being portrayed).

The trial is evaluating the effect of adding verbal risk terms to the numerical information. Also, the use of the terms 'may' and 'will' to convey risk.

Intervention type

Drug

Phase

Not Applicable

Drug names

Taxol

Primary outcome measures

1. Estimated frequency of any side effect occurring.
2. Estimates frequency of 5 individual side effects.

Secondary outcome measures

1. Estimated severity and degree of harm from the side effects
2. Participants' numeracy.

Overall trial start date

01/01/2013

Overall trial end date

01/04/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Adults (aged 16 or over) accessing the study via two pages (http://www.cancerresearchuk.org/cancer-help/about-cancer/treatment/cancer-drugs/paclitaxel AND http://www.cancerresearchuk.org/cancer-help/about-cancer/treatment/cancer-drugs/) on the Cancer Help UK website.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

318

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/01/2013

Recruitment end date

01/04/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Health Sciences
York
LS10 9DD
United Kingdom

Sponsor information

Organisation

University of York (UK)

Sponsor details

Department of Health Sciences
York
LS10 9DD
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University of Leeds (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

Funder name

University of York (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

Publication citations

Additional files

Editorial Notes