Condition category
Cancer
Date applied
20/10/2011
Date assigned
20/10/2011
Last edited
26/11/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Guy Makin

ORCID ID

Contact details

Royal Manchester Children’s 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 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

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 measures

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

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 Children’s 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

http://www.cmft.nhs.uk/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes