A randomised controlled trial of the effects of a web based Prostate Specific Antigen decision explorer, Prosdex

ISRCTN	ISRCTN48473735
DOI	https://doi.org/10.1186/ISRCTN48473735
Secondary identifying numbers	RCUC062 C6475/A7490

Submission date: 21/03/2007
Registration date: 26/04/2007
Last edited: 15/12/2011

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

Not provided at time of registration

Contact information

Prof Glyn Elwyn
Scientific

Department of Primary Care and Public Health
Centre for Health Sciences Research
Cardiff University
2nd Floor, Neuadd Meirionnydd
Heath Park
Cardiff
CF14 4YS
United Kingdom

Email	elwyng@cardiff.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Quality of life
Scientific title
Study acronym	PROSDEX
Study hypothesis	To evaluate the effects on men of a web-based Prostate Specific Antigen (PSA) decision-aid, Prosdex. The objectives are to assess the effect of Prosdex on: 1. Knowledge of PSA and prostate cancer-related issues 2. Attitudes to testing 3. Decision conflict 4. Anxiety 5. Intention to undergo PSA testing 6. Uptake of PSA testing In addition, a mathematical simulation model of the effects of Prosdex on subsequent resource use and health outcomes will be developed. The null hypothesis, based on the principal outcome, knowledge, is that Prosdex would not have an effect on knowledge of PSA and prostate cancer-related issues.
Ethics approval(s)	Approval received from the South East Wales Research Ethics Committee, Panel D on the 8th January 2007 (ref: 06/WSE04/138).
Condition	PSA decision aids, prostate cancer
Intervention	A web-based PSA decision aid, Prosdex: it will require a password for access and will generate the online questionnaire. Intervention group: Group one: Men in intervention group one will be asked to log onto and view the website, either in their own homes or in another setting of their choice. Group two: The second intervention group will receive a paper document comprising the text of the website. This enables evaluation of the Prosdex features (e.g. video clips and the structured decision support) that go beyond the mere presentation of the text content. Control group: Group three: In the first control group, men, after inserting their password, will be asked to complete the online questionnaire without viewing Prosdex. Group four: The second control group will not initially be given the details of the study website.
Intervention type	Other
Primary outcome measure	Knowledge of PSA and prostate cancer-related issues: this will be assessed using a set of knowledge questions, used in an earlier evaluation of a brief paper-based leaflet about PSA testing, which showed an ability to discriminate between intervention and control groups. The primary outcome, knowledge, will be measured immediately after the intervention: that is, men will be directed, automatically, from the Prosdex website to the online questionnaire. Men in the second intervention group and the first control group will also be asked at T0 to log onto the online questionnaire.
Secondary outcome measures	The secondary outcome measures will be measured immediately after the intervention: that is, men will be directed, automatically, from the Prosdex website to the online questionnaire. 1. Attitudes to testing: this will use a 12-item scale developed and used in the same evaluation of a brief paper-based leaflet about PSA testing 2. Decision conflict: this scale measures patients confidence or uncertainty (conflict) about whether they feel their choice is the best for them personally. It has acceptable validity and reliability (internal consistency alpha coefficients range from 0.78 - 0.89; test-retest reliability coefficients exceed 0.80). Given the nature of the decision about having a PSA test, with a high degree of uncertainty likely to affect decision making, it is important to use this, the most widely used outcome measure in decision aid studies 3. Anxiety: This will be assessed using the short form Spielberger questionnaire for state anxiety, validated and shown to be responsive in our earlier studies of shared decision making and risk communication 4. Intention to undergo PSA testing: this will be assessed using a single item question, with Likert-like response scale, which has also been used in our earlier evaluation of a brief paper-based leaflet about PSA testing 5. Uptake of the PSA test: measured six months after the intervention In addition, based on these results, a mathematical simulation model of the effects of Prosdex on subsequent resource use and health outcomes will also be developed. Secondary outcomes one to four, in addition to the primary outcome, knowledge, will be gathered from the online questionnaire. After the six month PSA testing, all the men will be asked to to complete the online questionnaire again.
Overall study start date	01/10/2007
Overall study end date	01/06/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target number of participants	600
Participant inclusion criteria	Men between ages of 50 and 75
Participant exclusion criteria	1. Previous PSA test or prostate cancer 2. Inability to access internet 3. Men who are known to be unable to read English 4. Serious uncontrolled medical conditions or concurrent medical illness likely to compromise life expectancy 5. Severe mental illness or dementia
Recruitment start date	01/10/2007
Recruitment end date	01/06/2008

Locations

Countries of recruitment

United Kingdom
Wales

Study participating centre

Department of Primary Care and Public Health

Cardiff
CF14 4YS
United Kingdom

Sponsor information

Cardiff University (UK)
University/education

Research and Commercial Division
7th floor, McKenzie House
30 - 36 Newport Road
Cardiff
CF24 0DE
Wales
United Kingdom

Email	DaviesKP2@cf.ac.uk
Website	http://www.cardiff.ac.uk/index.html
"ROR"	https://ror.org/03kk7td41

Funders

Funder type

Charity

Cancer Research UK (UK) (ref: C6475)
Private sector organisation / Other non-profit organizations

Alternative name(s): CR_UK, Cancer Research UK - London, CRUK
Location: United Kingdom

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	1. results	26/05/2010		Yes	No
Results article	results	06/08/2010		Yes	No