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Training for Parents of Children with Newly Diagnosed Cancer: a Randomised Controlled Trial


- candidate number2546
- NTR NumberNTR953
- ISRCTNISRCTN24016185
- Date ISRCTN created30-mei-2007
- date ISRCTN requested22-mei-2007
- Date Registered NTR12-apr-2007
- Secondary IDs 
- Public TitleTraining for Parents of Children with Newly Diagnosed Cancer: a Randomised Controlled Trial
- Scientific TitleTraining for Parents of Children with Newly Diagnosed Cancer: a Randomised Controlled Trial
- ACRONYM
- hypothesis1. 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
- Healt Condition(s) or Problem(s) studiedPediatric cancer, Training for parents, Distress, Parenting stress, Psycho-social intervention
- Inclusion criteriaParents of children with newly diagnosed cancer who can speak, read and write the Dutch language
- Exclusion criteriaParents of children with newly diagnosed AML/Non Hodgkin Lymfoma and Parents who are not able to speak, read and write the Dutch language
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-okt-2006
- planned closingdate1-jan-2013
- Target number of participants300
- InterventionsProblem Solving Skills Training for parents based on Problem Solving Therapy is a training program which incorporates cognitive behavioural principles facilitating coping in stressful situations. Parents of pediatric cancer patients in the training group will be offered 5 face-to-face sessions in which the principles of problem solving will be applied.
- Primary outcomeWe expect a decrease in the parents' general distress and parenting stress in the intervention group. This willl be measured by the Profile of Mood States, which measures among others depression, tension and fatigue; Parenting Stress Index-short form which measures the level of stress in the parent-child dyad. Measure moments: T0 approximately 5 weeks after diagnoses, T1 six months after diagnoses, T2 one year after diagnoses, T3 two year after diagnoses.
- Secondary outcomeWe 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 the Impact of Family Scale, which is a measure of the impact of chronic illness on a family; the Dutch version of the Child Behaviour Checklist, is a proxy measure of behavioural and emotional problems in childeren; the Child Health Questionnaire which is measure of the child's health status. Measure moments: T0 approximately 5 weeks after diagnoses, T1 six months after diagnoses, T2 one year after diagnoses, T3 two year after diagnoses.
- Timepoints
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMScN Corry Hoed-Heerschop, van den
- CONTACT for SCIENTIFIC QUERIESProf. Dr. Rob Pieters
- Sponsor/Initiator Erasmus Medical Center, Sophia Children's Hospital
- Funding
(Source(s) of Monetary or Material Support)
Zorgonderzoek Erasmus Medical Center
- Publications
- Brief summaryThe aim of the study is to evaluate a training, for parents of a child with newly diagnosed cancer, in order to decrease parenting stress and general distress. In addition, the aim is to identify predictors of adjustment, such as family functioning, child behaviour and disease severity. This will enable future health professionals to identify families most in need of additional care, by means of such a training. Parents of children with cancer who are faced with a very distressing situation have indicated unmet needs, regarding their medical care. Due to the shift of care from hospital to home parents are faced with a substantial burden when it comes to the care of their child. Therefore we propose to implement a training, which has proved successful for different patient groups, namely Problem-Solving Therapy. This training is based on cognitive behavioural processes which enables patients to create coping processes in response to stressful events. The appeal of such a training is enhanced by the fact that it is highly scripted, and easily administered (by a trained research nurse), thereby increasing its feasibility. The effectiveness of the training will be tested in a longitudinal stratified randomised controlled study, consisting of a training group (n = 150) and a control group (n = 150). At baseline (t0), before the start of the intervention, all parents included in the study will complete several questionnaires. T0 will take place approximately 3 weeks after diagnosis. The training will subsequently be implemented over approximately 10 weeks, after which questionnaires will be completed (t1). Follow-up at 6 months and one year after diagnosis (t2 and t3) will conclude the study. This intervention, which is based on cognitive behavioural principles is well established and has proved successful for patients with varying chronic diseases. The two outcome variables, general distress and parenting stress, will be measured by questionnaires, the Profile of Mood Scale and the Parenting Stress Index, respectively. Predictor variables will also be measured by questionnaires: the Impact on Family Scale, which measures family functioning, the Child Behaviour Checklist, which measures child behaviour and the Child Health Questionnaire which is measure of the child’s health status.
- Main changes (audit trail)
- RECORD12-apr-2007 - 11-jun-2007


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