Condition category
Cancer
Date applied
21/03/2007
Date assigned
26/04/2007
Last edited
15/12/2011
Prospective/Retrospective
Prospectively 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 Glyn Elwyn

ORCID ID

Contact details

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
elwyng@cardiff.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RCUC062 C6475/A7490

Study information

Scientific title

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

Approval received from the South East Wales Research Ethics Committee, Panel D on the 8th January 2007 (ref: 06/WSE04/138).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/10/2007

Overall trial end date

01/06/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Men between ages of 50 and 75

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

600

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

Trial participating centre

Department of Primary Care and Public Health
Cardiff
CF14 4YS
United Kingdom

Sponsor information

Organisation

Cardiff University (UK)

Sponsor details

Research and Commercial Division
7th floor
McKenzie House
30 - 36 Newport Road
Cardiff
CF24 0DE
United Kingdom
DaviesKP2@cf.ac.uk

Sponsor type

University/education

Website

http://www.cardiff.ac.uk/index.html

Funders

Funder type

Charity

Funder name

Cancer Research UK (UK) (ref: C6475)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

1.2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20507844
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20693148

Publication citations

  1. Results

    Evans R, Joseph-Williams N, Edwards A, Newcombe RG, Wright P, Kinnersley P, Griffiths J, Jones M, Williams J, Grol R, Elwyn G, Supporting informed decision making for prostate specific antigen (PSA) testing on the web: an online randomized controlled trial., J. Med. Internet Res., 2010, 12, 3, e27, doi: 10.2196/jmir.1305.

  2. Joseph-Williams N, Evans R, Edwards A, Newcombe RG, Wright P, Grol R, Elwyn G, Supporting informed decision making online in 20 minutes: an observational web-log study of a PSA test decision aid., J. Med. Internet Res., 2010, 12, 2, e15, doi: 10.2196/jmir.1307.

Additional files

Editorial Notes