Condition category
Cancer
Date applied
30/05/2007
Date assigned
30/05/2007
Last edited
30/05/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.erasmusmc.nl/content/englishindex.htm

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

Publication citations

Additional files

Editorial Notes