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
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