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 Children’s Hospital
Oxford Road
Manchester
M13 9WL
United Kingdom

Email guy.makin@manchester.ac.uk

Study information

Study designInterventional prevention randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typePrevention
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleDoes an interactive child-centred workshop reduce treatment-related distress and improve quality of life in children with leukaemia?
Study objectivesThis is a prospective study in which children (n=120) aged between 7 and 12 years who have been treated for leukaemia at Royal Manchester Children’s 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) studiedNational Cancer Research Network: Paediatric Oncology, Disease: Leukaemia (acute), Leukaemia (acute myeloid), Leukaemia (acute lymphoblastic), Paediatrics
InterventionThe 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 typeOther
Primary outcome measure1. 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 measures1. 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 date02/01/2012
Completion date01/01/2013

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit7 Years
Upper age limit12 Years
SexBoth
Target number of participantsPlanned Sample Size: 120; UK Sample Size: 120; Description: Two groups of 60, early and delayed intervention.
Total final enrolment58
Key inclusion criteria1. 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 criteria1. Age under 7 or over 12 years
2. Other types of maligant disease
Date of first enrolment02/01/2012
Date of final enrolment01/01/2013

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Royal Manchester Children’s 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 logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot 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.