Promoting testicular self-examination and awareness amongst young men with learning disability

ISRCTN	ISRCTN67971984
DOI	https://doi.org/10.1186/ISRCTN67971984
Protocol serial number	N/A
Sponsor	St George's University of London (UK)
Funder	Department of Health (UK) - Primary Care Studies Programme

Submission date: 24/06/2011
Registration date: 25/08/2011
Last edited: 24/10/2019

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 of protocol

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

Contact information

Prof Sheila Hollins
Scientific

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

Email	shollins@sgul.ac.uk

Study information

Primary study design	Interventional
Study design	Multi-centre randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Promoting testicular self-examination and awareness amongst young men with learning disability: a randomised controlled trial
Study objectives	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(s)	1. Wandsworth LREC, 25/10/2011, ref: 01.78.23 2. Kingston and Richmond LREC, November 2001 3. Merton and Sutton LREC, November 2001
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	Assessment of health anxiety
Completion date	30/03/2003

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target sample size at registration	192
Key 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
Key exclusion criteria	Lack of capacity to consent
Date of first enrolment	01/12/2001
Date of final enrolment	30/03/2003

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

St George's University of London

London
SW17 0RE
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2018	24/10/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

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