Training for parents of children with newly diagnosed cancer: a randomised controlled trial
ISRCTN | ISRCTN24016185 |
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DOI | https://doi.org/10.1186/ISRCTN24016185 |
Secondary identifying numbers | NL929 (NTR953) |
- 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
Scientific
Erasmus Medical Centre Sophia
Room Sb 2607
P.O. Box 2060
Rotterdam
3000 CB
Netherlands
Phone | +31 (0)10 4636587 |
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c.vandenhoed@erasmusmc.nl |
Study information
Study design | Randomised, active controlled, parallel group trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Quality of life |
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 | 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 study start date | 01/10/2006 |
Completion date | 01/01/2013 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Not Specified |
Target number of participants | 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
3000 CB
Netherlands
Sponsor information
Erasmus Medical Centre (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Sophia Children's Hospital
Dr. Molewaterplein 60
Rotterdam
3015 GJ
Netherlands
Website | http://www.erasmusmc.nl/content/englishindex.htm |
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https://ror.org/018906e22 |
Funders
Funder type
Hospital/treatment centre
Health Services Research (ZorgOnderzoek) Erasmus Medical Centre (The Netherlands)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Editorial Notes
23/09/2021: Proactive update review. No publications found. Search options exhausted.