Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Background and study aims
Testicular cancer is the most common type of cancer affecting males between 15 and 34 years of age. Evidence suggests that men with intellectual disabilities (ID) are at increased risk of testicular cancer and may present late in the progression of the disease. The aim is to study the effect of two different educational programs in young men with ID.

Who can participate?
Males aged 16 or over, registered with a GP, known to learning disability services or on the learning disability register or known to have Down syndrome and the ability to consent.

What does the study involve?
Participants will be randomly assigned to either a ‘teaching’ group or a ‘leaflet’ group. The teaching sessions will be carried out with small groups with a maximum of six members in each. The teaching will be conducted by a Community Learning Disability Nurse Manager and a research assistant with learning disabilities. The teaching will be carried out in two 30-minute sessions. Participants in the leaflet group will be given a seven-page pictorial leaflet and encouraged to take it away and discuss with family, friends or carers if they wish. The effects of the interventions were assessed in terms of knowledge and skills, attitudes and anxiety one week after the interventions and again after 6 months.

What are the possible benefits and risks of participating?
This study teaches young men with ID how to spot the early signs of testicular cancer. Testicular cancer is almost always curable if found early. When young men with ID receive information in an accessible form they can feel more confident about having influence over their health and seeking help, leading to reduced anxiety levels. There are no foreseeable risks to participants.

Where is the study run from?
In London at various colleges, day centres, voluntary organisations and youth clubs

When is the study starting and how long is it expected to run for?
The study took place between 2002 and 2003

Who is funding the study?
Department of Health - Primary Care Studies Programme

Who is the main contact?
Baroness Hollins

Trial website

Contact information



Primary contact

Prof Sheila Hollins


Contact details

St George's University of London
Division of PHSE
Cranmer Terrace
SW17 0RE
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Promoting testicular self-examination and awareness amongst young men with learning disability: a randomised controlled trial


Study hypothesis

Null Hypothesis: Men who take part in a teaching programme will not illustrate a greater knowledge of testicular cancer, symptoms and signs or a greater skill with regard to self-examination than the control group who receive a suitably designed leaflet on the subject within (a) one week of intervention and (b) six months after the intervention.

Ethics approval

1. Wandsworth LREC, 25/10/2011, ref: 01.78.23
2. Kingston and Richmond LREC, November 2001
3. Merton and Sutton LREC, November 2001

Study design

Multi-centre randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.


Testicular cancer awareness


1. Teaching programme (intervention group)
2. Educative leaflet (control)

The intervention group received two 30-minute education sessions and the control group received a 7-page pictorial leaflet. The follow-up was at 1 week and again at 6 months. The duration of the intervention was 6 months

Intervention type



Not Applicable

Drug names

Primary outcome measure

1. State / Trait Anxiety Inventory
2. Wells Health Anxiety
3. Health Locus of Control, confidence and self-efficacy with regard to testicular self-exam and seeking help

All measures adopted existing inventories so as to be accessible to learning disability group. Used linear analogue scales. Measured at baseline, one week and six months post intervention.

Secondary outcome measures

Assessment of health anxiety

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Males aged 16 or over
2. Registered with a general practitioner (GP)
3. Known to learning disability services or on the learning disability register or known to have Down Syndrome
4. Have capacity to consent

Participant type


Age group




Target number of participants

192 (96 per arm of study)

Participant exclusion criteria

Lack of capacity to consent

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

St George's University of London
SW17 0RE
United Kingdom

Sponsor information


St George's University of London (UK)

Sponsor details

Cranmer Terrace
SW17 0RE
United Kingdom

Sponsor type




Funder type


Funder name

Department of Health (UK) - Primary Care Studies Programme

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Basic results (scientific)

Publication list

2018 results in: (added 24/10/2019)

Publication citations

Additional files

Editorial Notes

24/10/2019: Publication reference added. 09/08/2016: No publications found, verifying study status with principal investigator.