Reducing treatment related distress in children with leukaemia

ISRCTN	ISRCTN36769062
DOI	https://doi.org/10.1186/ISRCTN36769062
Secondary identifying numbers	10216

Submission date: 20/10/2011
Registration date: 20/10/2011
Last edited: 04/04/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

http://cancerhelp.cancerresearchuk.org/trials/a-study-looking-at-way-of-reducing-distress-caused-by-treatment-for-leukaemia-in-children

Contact information

Dr Guy Makin
Scientific

Royal Manchester Childrens Hospital
Oxford Road
Manchester
M13 9WL
United Kingdom

Email	guy.makin@manchester.ac.uk

Study information

Study design	Interventional prevention randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Does an interactive child-centred workshop reduce treatment-related distress and improve quality of life in children with leukaemia?
Study objectives	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(s)	North West 5 Haydock Park REC, 08/10/2010, ref: 10/H1010/45
Health condition(s) or problem(s) studied	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
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 study start date	02/01/2012
Completion date	01/01/2013

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	7 Years
Upper age limit	12 Years
Sex	Both
Target number of participants	Planned Sample Size: 120; UK Sample Size: 120; Description: Two groups of 60, early and delayed intervention.
Total final enrolment	58
Key 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
Key exclusion criteria	1. Age under 7 or over 12 years 2. Other types of maligant disease
Date of first enrolment	02/01/2012
Date of final enrolment	01/01/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Royal Manchester Childrens Hospital

Manchester
M13 9WL
United Kingdom

Sponsor information

Central Manchester University Hospitals NHS Trust (UK)
Hospital/treatment centre

Genetic Medicine
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
England
United Kingdom

Website	http://www.cmft.nhs.uk/
"ROR"	https://ror.org/00he80998

Funders

Funder type

Government

National Institure for Health Research (NIHR) - Research for Patient Benefit (RfPB) (UK)

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	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Plain English results			04/04/2022	No	Yes

Editorial Notes

04/04/2022: Plain English results and total final enrolment added.
13/02/2018: No publications found in PubMed, verifying study status with principal investigator.