Condition category
Cancer
Date applied
21/04/2011
Date assigned
21/04/2011
Last edited
01/05/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Irene Tuffrey-Wijne

ORCID ID

Contact details

St George's University of London
Division of Mental Health
Cranmer Terrace
London
SW17 0RE
United Kingdom
ituffrey@sgul.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

9463

Study information

Scientific title

Acronym

Study hypothesis

1. To explore the experiences of people with learning disabilities who have a relative or friend with cancer
2. To identify the cancer information and support needs of this group
3. To identify the barriers people with learning disabilities face to receiving adequate information and support when a relative or friend has cancer
4. To make recommendations for
4.1.Practice
4.2. The development of resources
4.3. Future research, to ensure that people with learning disabilities are adequately supported when a relative or friend has cancer

Ethics approval

Medical Research Ethics Committee on 10/06/2009 Ref: 09/H0716/37

Study design

Multi-Centre Non-randomised Interventional Process of Care

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

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

Condition

All cancers

Intervention

1. Four focus groups of 6 participants
2. Each focus group will meet 4 times:
2.1. ‘Getting to know you’: introducing the study, and beginning to tell your story
2.2. What was good/difficult about what other people did (or didn’t do) to help you understand and manage?
2.3. What could have been done better? What are your recommendations?
2.4. Nominal Group Technique will be used to elicit the most important recommendation
3. The focus groups will be conducted by two researchers (one to moderate the discussion, and one to make notes) and two co-researchers with learning disabilities who will support the lead researcher
4. The data will be analysed using content analysis supported by Nvivo software. All three researchers (including the co-researcher with learning disabilities) will analyse the data

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Participants' views on supportive measures, obtainted through Nominal Group Technique at the session 4 of each focus group
2. Final qualitative analysis of participants' views on completion of final focus group (April/May 2011)

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/02/2010

Overall trial end date

02/02/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. People with learning disabilities who have some verbal skills
2. Age 18 or over
3. Have lived with a relative/friend with cancer in the past 5 years
4. Target Gender: Male & Female
5. Lower Age Limit 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 24; UK Sample Size: 24

Participant exclusion criteria

Recent bereavement (less than 6 months)

Recruitment start date

01/02/2010

Recruitment end date

02/02/2011

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

Division of Mental Health
Cranmer Terrace
London
SW17 0RE
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Macmillan Cancer Support

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

1. Tuffrey-Wijne, I., Giatras, N., Butler, G., Cresswell, A. (2011) Supporting people with learning disabilities who are affected by a relative or friend with cancer: Final Report. London: Macmillan Cancer Support.
2. 2012 qualitative study results in http://www.ncbi.nlm.nih.gov/pubmed/22366626

Publication citations

  1. Qualitative study results

    Tuffrey-Wijne I, Giatras N, Butler G, Cresswell A, People with intellectual disabilities who are affected by a relative or friend with cancer: a qualitative study exploring experiences and support needs., Eur J Oncol Nurs, 2012, 16, 5, 512-519, doi: 10.1016/j.ejon.2012.01.002.

Additional files

Editorial Notes