Adjuvant psychological therapy for families of children with cancer: a controlled trial.

ISRCTN ISRCTN80132836
DOI https://doi.org/10.1186/ISRCTN80132836
Protocol serial number N0258016631
Sponsor Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Funder The Royal Marsden NHS Foundation Trust (UK) NHS R&D Support Funding
Submission date
29/09/2006
Registration date
29/09/2006
Last edited
16/10/2012
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Maggie Watson
Scientific

Psychological Medicine
The Royal Marsden NHS Foundation Trust
Downs Road
Sutton
SM2 5PT
United Kingdom

Phone +44 (0)20 8661 3006
Email maggie.watson@rmh.nhs.uk

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study objectivesTo evaluate paediatric adjuvant psychological therapy in this paediatric population.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedCancer: All
InterventionRandomised test intervention vs no intervention controls (phase III).

Added 05/10/10: trial stopped in 2006 due to poor recruitment
Intervention typeOther
Primary outcome measure(s)

Quality of life

Key secondary outcome measure(s)

Not provided at time of registration

Completion date01/04/2006
Reason abandoned (if study stopped)Participant recruitment issue

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit4 Years
Upper age limit16 Years
SexNot Specified
Target sample size at registration102
Key inclusion criteria102 RMH patients. All new admissions to the paediatric unit aged between 4-16 years
Key exclusion criteria1. Non-English speaking
2. Extremely poor medical prognosis
Date of first enrolment01/03/1995
Date of final enrolment01/04/2006

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Psychological Medicine
Sutton
SM2 5PT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan