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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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27 May 2013 |
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Main ID: |
NTR953 |
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Date of registration:
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12/04/2007 |
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Primary sponsor: |
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Public title:
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Training for Parents of Children with Newly Diagnosed Cancer: a Randomised Controlled Trial
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Scientific title:
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Training for Parents of Children with Newly Diagnosed Cancer: a Randomised Controlled Trial -
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Date of first enrolment:
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1/10/2006 |
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Target sample size:
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300 |
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Recruitment status: |
recruiting |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=953 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: -
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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Corry
Hoed-Heerschop, van den |
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Address:
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Erasmus MC Sophia, room Sb 2607
Postbus 2060
3000 CB
Rotterdam
The Netherlands |
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Telephone:
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+31 10 463 65 87 |
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Email:
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c.vandenhoed@erasmusmc.nl |
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Affiliation:
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Name:
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Rob
Pieters |
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Address:
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Erasmus Medical Center, Sophia Children's Hospital, Department of Oncology/Hematology,
P.O. Box 2060, Dr. Molewaterplein 60
3015 GJ
Rotterdam
The Netherlands |
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Telephone:
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+31 (0)10 4636691 |
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Email:
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rob.pieters@erasmusmc.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Parents of children with newly diagnosed cancer who can speak, read and write the Dutch language
Exclusion criteria: Parents of children with newly diagnosed AML/Non Hodgkin Lymfoma and Parents who are not able to speak, read and write the Dutch language
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Pediatric cancer, Training for parents, Distress, Parenting stress, Psycho-social intervention
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Intervention(s)
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Problem 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.
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Primary Outcome(s)
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We 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.
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Secondary Outcome(s)
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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 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.
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Secondary ID(s)
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ISRCTN24016185
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Source(s) of Monetary Support
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Zorgonderzoek Erasmus Medical Center
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