Promoting testicular self-examination and awareness amongst young men with learning disability
| ISRCTN | ISRCTN67971984 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67971984 |
| Secondary identifying numbers | N/A |
- 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
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
Scientific
St George's University of London
Division of PHSE
Cranmer Terrace
London
SW17 0RE
United Kingdom
| shollins@sgul.ac.uk |
Study information
| Study design | Multi-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/12/2001 |
| Completion date | 30/03/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 192 (96 per arm of study) |
| 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
- England
- United Kingdom
Study participating centre
SW17 0RE
United Kingdom
Sponsor information
University/education
Cranmer Terrace
London
SW17 0RE
England
United Kingdom
| Website | http://www.sgul.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/040f08y74 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
Editorial Notes
24/10/2019: Publication reference added.
09/08/2016: No publications found, verifying study status with principal investigator.
