Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Dr Guy Makin
ORCID ID
Contact details
Royal Manchester Childrens Hospital
Oxford Road
Manchester
M13 9WL
United Kingdom
-
guy.makin@manchester.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
10216
Study information
Scientific title
Does an interactive child-centred workshop reduce treatment-related distress and improve quality of life in children with leukaemia?
Acronym
Study hypothesis
This is a prospective study in which children (n=120) aged between 7 and 12 years who have been treated for leukaemia at Royal Manchester Childrens Hospital will be invited to participate in a series of child-centred interactive workshops which use puzzles and games to teach children about basic human biology, leukaemia and its treatment. The aim of the study is to evaluate whether these workshops are able to reduce treatment-related distress and improve quality of life in these children.
Ethics approval
North West 5 Haydock Park REC, 08/10/2010, ref: 10/H1010/45
Study design
Interventional prevention randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
National Cancer Research Network: Paediatric Oncology, Disease: Leukaemia (acute), Leukaemia (acute myeloid), Leukaemia (acute lymphoblastic), Paediatrics
Intervention
The children will be randomised to an immediate group and a delayed control group. The immediate group will attend the workshops straight away, whilst the delayed group will serve as the controls and will attend the workshops after an 18 week interval. The child-centred interactive workshop will be delivered once weekly for 4 weeks. A series of standardised and validated questionnaires will be used to assess anxiety and fear of medical procedures, child quality of life, child emotional and behavioural functioning, the parental care-giving burden, and self-efficacy in both groups before and after workshop attendance. The effectiveness of the workshops will be analysed using a multi-level growth curve modelling approach. The data collected will be coded to protect patient confidentiality. Participation in the study will not influence the clinical care of the patients enrolled on the study. Followed up afer 6 months.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Quality of life
2. Emotional and behavioural functioning
Theses are measured immediately before, immediately after intervention, at 12 weeks and at 6 months
Secondary outcome measures
1. Caregiving burden
2. Ffear of medical procedure
3. Self-efficacy
These are measured immediately before, immediately after intervention, at 12 weeks and at 6 months.
Overall trial start date
02/01/2012
Overall trial end date
01/01/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients aged between 7 and 12 years
2. Treated for leukaemia at Royal Manchester Children's Hospital
3. Parents must be able to receive and understand verbal and written information about the study and give written informed consent
4. Male and female participants
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
Planned Sample Size: 120; UK Sample Size: 120; Description: Two groups of 60, early and delayed intervention.
Participant exclusion criteria
1. Age under 7 or over 12 years
2. Other types of maligant disease
Recruitment start date
02/01/2012
Recruitment end date
01/01/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Manchester Childrens Hospital
Manchester
M13 9WL
United Kingdom
Sponsor information
Organisation
Central Manchester University Hospitals NHS Trust (UK)
Sponsor details
Genetic Medicine
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
National Institure for Health Research (NIHR) - Research for Patient Benefit (RfPB) (UK)
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
Basic results (scientific)
Publication list