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

ISRCTN ISRCTN24016185
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

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

Study designRandomised, active controlled, parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeQuality of life
Scientific titleTraining for parents of children with newly diagnosed cancer: a randomised controlled trial
Study objectives1. 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) studiedDistress, paediatric cancer, parenting stress, psycho-social intervention, training for parents
InterventionProblem 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 typeOther
Primary outcome measureWe 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 measuresWe 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 date01/10/2006
Completion date01/01/2013

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants300
Key inclusion criteriaParents of children with newly diagnosed cancer who can speak, read and write the Dutch language.
Key exclusion criteria1. 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 enrolment01/10/2006
Date of final enrolment01/01/2013

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Erasmus Medical Centre Sophia
Rotterdam
3000 CB
Netherlands

Sponsor information

Erasmus Medical Centre (The Netherlands)
Hospital/treatment centre

Sophia Children's Hospital
Dr. Molewaterplein 60
Rotterdam
3015 GJ
Netherlands

Website http://www.erasmusmc.nl/content/englishindex.htm
ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

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