Crisis intervention for parents of children with newly diagnosed cancer: implementation and assessment of efficacy

ISRCTN ISRCTN74785352
DOI https://doi.org/10.1186/ISRCTN74785352
Secondary identifying numbers N/A
Submission date
08/12/2011
Registration date
12/01/2012
Last edited
03/09/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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 child’s illness and treatment. Our aim is to study whether crisis therapy intervention conducted by experienced professionals can help parents cope with their child’s 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, child’s cancer type) on the findings.

Who can participate?
Parents of a child recently diagnosed with cancer at the childhood cancer centre at Astrid Lindgren Children’s 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 child’s 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 child’s 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 child’s diagnosis.

What are the possible benefits and risks of participating?
The study focuses on a sensitive period - the first year following a child’s 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 child’s 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

Contact information

Prof Krister K Boman
Scientific

Karolinska Institutet
Department of Women’s and Children’s Health
Childhood Cancer Research Unit
Astrid Lindgren Children’s Hospital Q6:05
Stockholm
17176
Sweden

Email krister.boman@ki.se

Study information

Study designSingle-centre randomised clinical open-label trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleCrisis 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
Study objectives1. 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(s)The Karolinska Institute Ethics Committee, Stockholm, 21/10/1999, ref: dnr 99-240
Health condition(s) or problem(s) studiedPost-traumatic stress, anxiety, depression
InterventionCIP-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 typeOther
Primary outcome measure1. 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 measuresFor 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 study start date01/10/2000
Completion date31/03/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsApproximately 350
Key inclusion criteria1. Parents of a child with a recent primary cancer diagnosis (i.e. newly diagnosed)
2. The child registered at the study treatment center
Key exclusion criteria1. 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
Date of first enrolment01/10/2000
Date of final enrolment31/03/2005

Locations

Countries of recruitment

  • Sweden

Study participating centre

Karolinska Institutet
Stockholm
17176
Sweden

Sponsor information

Swedish Childhood Cancer Foundation (Sweden)
Government

PO box 5408
Stockholm
11484
Sweden

Website http://www.barncancerfonden.se/
ROR logo "ROR" https://ror.org/05072yv34

Funders

Funder type

Government

Swedish Childhood Cancer Foundation (Sweden), ref: PROJ98/006

No information available

Swedish Cancer and Traffic Injury Fund (Sweden), ref: C 20002

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