Plain English Summary
Background and study aims
When a child is diagnosed with cancer, this entails a crisis for the parents, a traumatic situation that can cause both immediate and long-term psychological stress. Therapy programmes offered to parents during the year following the cancer diagnosis may help them to manage the psychological stresses associated with the childs illness and treatment. Our aim is to study whether crisis therapy intervention conducted by experienced professionals can help parents cope with their childs illness, reducing levels of traumatic stress caused by the diagnosis and treatment. We shall also study the possible influence of various socio-demographic factors (parents age, sex, education, childs cancer type) on the findings.
Who can participate?
Parents of a child recently diagnosed with cancer at the childhood cancer centre at Astrid Lindgren Childrens Hospital in Stockholm.
What does the study involve?
Parents are randomly allocated to an intervention group or a control group. At the beginning of the study period, all parents are asked to fill in a questionnaire in order to gauge the levels of distress they may be experiencing in relation to their childs recently diagnosed illness. They will be asked to fill in same questionnaire once the intervention programme is over, to see whether distress levels have changed since the first occasion when distress was assessed. Parents in the intervention group are offered face to face, 90 minute sessions with the intervention staff. Participation begins shortly after the childs diagnosis and the programme will be concluded within 12 months. Parents in the control group will not take part in the study intervention, only in the assessments of distress. For both groups, assessments of distress take place at similar points in time from the childs diagnosis.
What are the possible benefits and risks of participating?
The study focuses on a sensitive period - the first year following a childs cancer so addressing parents thoughts and feelings associated with the experience may be accompanied by discomfort and emotional pain. At the same time, evidence shows that therapy can be helpful when facing emotional pain and stress, providing parents with support and strength in coping with their childs illness.
Where is the study run from?
Karolinska Institutet (Sweden).
When is study starting and how long is it expected to run for?
The study ran from October 2000 to March 2005.
Who is funding the study?
The study is funded by The Swedish Childhood Cancer Foundation and The Cancer and Traffic Injury Foundation, Sweden.
Who is the main contact?
Assoc. Professor Krister K Boman
krister.boman@ki.se
Trial website
Contact information
Type
Scientific
Primary contact
Prof Krister K Boman
ORCID ID
Contact details
Karolinska Institutet
Department of Womens and Childrens Health
Childhood Cancer Research Unit
Astrid Lindgren Childrens Hospital Q6:05
Stockholm
17176
Sweden
krister.boman@ki.se
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Crisis intervention for parents of children with newly diagnosed cancer: development, implementation and assessment of efficacy of a model for treatment of distress and traumatic stress symptoms in a randomised controlled trial where post-intervention distress symptom levels of cases are compared with those of controls receiving standard treatment as usual
Acronym
Study hypothesis
1. Is participation in the crisis intervention for parents of children with newly diagnosed cancer associated with less severe psychological symptoms measured post-intervention compared to outcomes of controls receiving only treatment as usual (TAU)?
2. Is the decrease in distress/stress greater among parents offered CIP-CC (Crisis Intervention Program for parents with Children with newly diagnosed Cancer) compared to TAU.
3. How do CIP-CC participants experience and evaluate the CIP-CC?
We hypothesised that participants in the intervention would display less severe symptoms post-intervention than parents receiving TAU
Ethics approval
The Karolinska Institute Ethics Committee, Stockholm, 21/10/1999, ref: dnr 99-240
Study design
Single-centre randomised clinical open-label trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Post-traumatic stress, anxiety, depression
Intervention
CIP-CC program: manual-guided, structured and time-limited psychological crisis intervention. Duration: 12 months
Control: treatment as usual, consisting of standard routine psychosocial attention of the treatment unit.
Total duration of follow-up: approximately 13 months
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Illness-specific distress and generic symptoms of anxiety and depression assesed using the standardised 'Parental Psychosocial Distress in Cancer' (PPD-C) - a 125 item self-report instrument
2. Traumatic and post-traumatic stress assessed using the standardised 'Impact of Events Scale - revised' (IES-R) - a 22-item self-report instrument
Assessed at baseline and follow-up.
Secondary outcome measures
For intervention participants:
1. The Client Satisfaction Questionnaire (CSQ-8) to assess participants unitary general satisfaction
2. Evaluation of efficacy and feasibility of the CIP-CC program
Overall trial start date
01/10/2000
Overall trial end date
31/03/2005
Reason abandoned
Eligibility
Participant inclusion criteria
1. Parents of a child with a recent primary cancer diagnosis (i.e. newly diagnosed)
2. The child registered at the study treatment center
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Approximately 350
Participant exclusion criteria
1. Child registered for treatment of a relapse
2. Child suffering from a known 100% fatal malignancy
3. Child in a palliative treatment stage
4. Parent does not speak Swedish
Recruitment start date
01/10/2000
Recruitment end date
31/03/2005
Locations
Countries of recruitment
Sweden
Trial participating centre
Karolinska Institutet
Stockholm
17176
Sweden
Sponsor information
Organisation
Swedish Childhood Cancer Foundation (Sweden)
Sponsor details
PO box 5408
Stockholm
11484
Sweden
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Swedish Childhood Cancer Foundation (Sweden), ref: PROJ98/006
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Swedish Cancer and Traffic Injury Fund (Sweden), ref: C 20002
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