Reducing treatment related distress in children with leukaemia
ISRCTN | ISRCTN36769062 |
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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
Contact information
Dr Guy Makin
Scientific
Scientific
Royal Manchester Childrens Hospital
Oxford Road
Manchester
M13 9WL
United Kingdom
guy.makin@manchester.ac.uk |
Study information
Study design | Interventional prevention randomised controlled trial |
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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 |
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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
M13 9WL
United Kingdom
Sponsor information
Central Manchester University Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Genetic Medicine
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
England
United Kingdom
Website | http://www.cmft.nhs.uk/ |
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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 | |
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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? |
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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.