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ISRCTN
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ISRCTN74785352
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ClinicalTrials.gov identifier
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Public title
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Crisis intervention for parents of children with newly diagnosed cancer: implementation and assessment of efficacy
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Scientific title
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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
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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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
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Lay summary
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Lay summary under review
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Ethics approval
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The Karolinska Institute Ethics Committee, Stockholm 21 Octobers 1999, ref: dnr 99-240
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Study design
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Single-centre randomised clinical open-label trial
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Countries of recruitment
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Sweden
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Disease/condition/study domain
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Post-traumatic stress, anxiety, depression
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Participants - inclusion criteria
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1. Parents of a child with a recent primary cancer diagnosis (i.e. newly diagnosed)
2. The child registered at the study treatment center
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Participants - exclusion criteria
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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
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Anticipated start date
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01/10/2000
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Anticipated end date
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31/03/2005
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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Approximately 350
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Interventions
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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
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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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
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Sources of funding
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1. Swedish Childhood Cancer Foundation (Sweden) ref: PROJ98/006
2. Swedish Cancer and Traffic Injury Fund (Sweden) ref: C 20002
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Trial website
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Publications
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Contact name
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Prof
Krister K
Boman
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Address
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Karolinska Institutet
Department of Women’s and Children’s Health
Childhood Cancer Research Unit
Astrid Lindgren Children’s Hospital Q6:05
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City/town
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Stockholm
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Zip/Postcode
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17176
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Country
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Sweden
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Email
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krister.boman@ki.se
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Sponsor
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Swedish Childhood Cancer Foundation (Sweden)
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Address
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PO box 5408
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City/town
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Stockholm
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Zip/Postcode
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11484
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Country
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Sweden
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Sponsor website:
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http://www.barncancerfonden.se/
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Date applied
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08/12/2011
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Last edited
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12/01/2012
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Date ISRCTN assigned
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12/01/2012
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