Condition category
Cancer
Date applied
24/06/2011
Date assigned
25/08/2011
Last edited
08/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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
shollins@sgul.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Sheila Hollins

ORCID ID

Contact details

St George's University of London
Division of PHSE
Cranmer Terrace
London
SW17 0RE
United Kingdom
-
shollins@sgul.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

Acronym

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

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

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

Condition

Testicular cancer awareness

Intervention

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

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

01/12/2001

Overall trial end date

30/03/2003

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Male

Target number of participants

192 (96 per arm of study)

Participant exclusion criteria

Lack of capacity to consent

Recruitment start date

01/12/2001

Recruitment end date

30/03/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

St George's University of London (UK)

Sponsor details

Cranmer Terrace
London
SW17 0RE
United Kingdom

Sponsor type

University/education

Website

http://www.sgul.ac.uk/

Funders

Funder type

Government

Funder name

Department of Health (UK) - Primary Care Studies Programme

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

09/08/2016: No publications found, verifying study status with principal investigator.