Training for parents of children with newly diagnosed cancer: a randomised controlled trial

ISRCTN	ISRCTN24016185
DOI	https://doi.org/10.1186/ISRCTN24016185
Protocol serial number	NL929 (NTR953)
Sponsor	Erasmus Medical Centre (The Netherlands)
Funder	Health Services Research (ZorgOnderzoek) Erasmus Medical Centre (The Netherlands)

Submission date: 30/05/2007
Registration date: 30/05/2007
Last edited: 23/09/2021

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

Not provided at time of registration

Contact information

Ms Corry van den Hoed-Heerschop
Scientific

Erasmus Medical Centre Sophia
Room Sb 2607
P.O. Box 2060
Rotterdam
3000 CB
Netherlands

Phone	+31 (0)10 4636587
Email	c.vandenhoed@erasmusmc.nl

Study information

Primary study design	Interventional
Study design	Randomised, active controlled, parallel group trial
Secondary study design	Randomised controlled trial
Scientific title	Training for parents of children with newly diagnosed cancer: a randomised controlled trial
Study objectives	1. A training, for parents of a child with newly diagnosed cancer, will decreasing general distress and parenting stress 2. Identifying predictors of adjustment, such as family functioning, child behaviour and disease severity
Ethics approval(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	Distress, paediatric cancer, parenting stress, psycho-social intervention, training for parents
Intervention	Problem Solving Skills Training for parents based on Problem Solving Therapy is a training program that incorporates cognitive behavioural principles facilitating coping in stressful situations. Parents of paediatric cancer patients in the training group will be offered five face-to-face sessions in which the principles of problem solving will be applied.
Intervention type	Other
Primary outcome measure(s)	We expect a decrease in the parents' general distress and parenting stress in the intervention group. This will be measured by: 1. The Profile of Mood States, which measures among others depression, tension and fatigue 2. Parenting Stress Index-short form, which measures the level of stress in the parent-child dyad Measure moments: T0: approximately five weeks after diagnoses T1: six months after diagnoses T2: one year after diagnoses T3: two year after diagnoses
Key secondary outcome measure(s)	We expect a decrease in the problems of child behaviour and an increase in quality of life in the intervention group. This will be measured by: 1. The Impact of Family Scale, which is a measure of the impact of chronic illness on a family 2. The Dutch version of the Child Behaviour Checklist, this is a proxy measure of behavioural and emotional problems in children 3. The Child Health Questionnaire, which is measure of the child's health status Measure moments: T0: approximately five weeks after diagnoses T1: six months after diagnoses T2: one year after diagnoses T3: two year after diagnoses
Completion date	01/01/2013

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	300
Key inclusion criteria	Parents of children with newly diagnosed cancer who can speak, read and write the Dutch language.
Key exclusion criteria	1. Parents of children with newly diagnosed Acute Myeloid Leukaemia (AML)/Non Hodgkin Lymphoma 1. Parents who are not able to speak, read and write the Dutch language
Date of first enrolment	01/10/2006
Date of final enrolment	01/01/2013

Locations

Countries of recruitment

Netherlands

Study participating centre

Erasmus Medical Centre Sophia

Rotterdam
3000 CB
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Editorial Notes

23/09/2021: Proactive update review. No publications found. Search options exhausted.