Contact information
Type
Scientific
Primary contact
Ms Corry van den Hoed-Heerschop
ORCID ID
Contact details
Erasmus Medical Centre Sophia
Room Sb 2607
P.O. Box 2060
Rotterdam
3000 CB
Netherlands
+31 (0)10 4636587
c.vandenhoed@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
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
Ethics approval received from the local medical ethics committee
Study design
Randomised, active controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Quality of life
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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
Secondary outcome measures
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
Overall trial start date
01/10/2006
Overall trial end date
01/01/2013
Reason abandoned
Eligibility
Participant inclusion criteria
Parents of children with newly diagnosed cancer who can speak, read and write the Dutch language.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
300
Participant 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
Recruitment start date
01/10/2006
Recruitment end date
01/01/2013
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus Medical Centre Sophia
Rotterdam
3000 CB
Netherlands
Sponsor information
Organisation
Erasmus Medical Centre (The Netherlands)
Sponsor details
Sophia Children's Hospital
Dr. Molewaterplein 60
Rotterdam
3015 GJ
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Health Services Research (ZorgOnderzoek) Erasmus Medical Centre (The Netherlands)
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