Trial document





This trial has been registered retrospectively.
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  DRKS00000654

Trial Description

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Title

Psychoeducation for siblings of pediatric cancer patients – development, evaluation and implementation of an intervention program

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Siblings of pediatric cancer patients often experience psychological and social symptoms. They often lack sufficient knowledge about the disease and its treatment. Family-oriented programs address the siblings' psychosocial problems, nevertheless there is a lack of standardized material which can be used for the psychoeducting the siblings. Studies have shown that an increase in knowledge is associated with a decrease of anxiety and other psychological symptoms in the siblings. Therefore this study aims at developing a standardized intervention program for children. This work is carried out in collaboration with the after-care clinic Tannheim and the rehabilitation clinic Katharinenhöhe. The impact of the intervention on the siblings' psychological distress, their cancer-related knowledge and their satisfaction with their family life is studied.

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Brief Summary in Scientific Language

Siblings of pediatric cancer patients often experience psychological and social problems. This study aims at developing a manual to structure psychosocial interventions for siblings of pediatric cancer patients. The intervention program is implemented and evaluated in the after-care clinic Tannheim and the rehabilitation clinic Katharinenhöhe.
Intervention effects are computed as a comparions between the pre- post and the follow-up measurements, as well as by comparisons to families who participate in the family oriented rehabilitation program without specific psychoeducation for siblings.

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Organizational Data

  •   DRKS00000654
  •   2011/01/19
  •   [---]*
  •   yes
  •   Approved
  •   Antrag Nr. 164/10, Ethik-Kommission der Universität Ulm
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Secondary IDs

  •   U1111-1119-0938 
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Health Condition or Problem studied

  •   psychological distress in healthy siblings of pediatric cancer patients
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Interventions/Observational Groups

  •   Control group: general family-oriented after-care for four weeks, no specific psychoeducational intervention for healthy siblings
  •   Intervention group: participation in the family-oriented after-care program for four weeks, within the framework of the after-care program the psychoeducational intervention takes place. The intervention consists of four appointments, each 45 minutes, one appointment per week.
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Supportive care
  •   Other
  •   N/A
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Primary Outcome

Primary Outcomes of this study are the siblings' psychological distress as well as their cancer-related knowlege. The sibling perception questionnaire (SPQ, Carpenter & Sahler, 1991) is used to measure psychological distress. Specific age appropriate questionnaires and an interview for preschoolers are used to measure cancer-related knowledge. These data are collected at the beginning of the family-oriented rehabilitation (t1), after the familiy-oriented rehabilitation (t2, 4 weeks after t1), and 2 months after the end of the family-oriented rehabilitation program.

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Secondary Outcome

Secondary outcomes of this study are the satisfaction with one's family situation, the siblings' and the parents' quality of life.
To measure the satisfactioin with one's family the Family-APGAR questionnaire is used (Austin & Huberty, 1989; Smilkstein, 1978). The siblings' quality of life is measured by the LQ-KID questionnaire (Goldbeck & Braun, 2003). The parents' quality of life is measure by means of the Ulm quality of Life Inventory for parents (Goldbeck & Storck, 2002). These data are collected at the beginning of the family-oriented rehabilitation (t1), after the familiy-oriented rehabilitation (t2, 4 weeks after t1), and 2 months after the end of the family-oriented rehabilitation program.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2010/11/28
  •   120
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   4   Years
  •   17   Years
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Additional Inclusion Criteria

The intervention is addressed to 4-17 year old siblings of pediatric cancer patients and their parents. The families should participate at a family-oriented rehability program at the after-care clinic Tannheim or the rehabilitation clinic Katharinenhöhe. The participating parents and their children should have sufficient knowledge of the German language and declare their written informed consent (parents) and informed assent (underage children) for participation in the study.

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Exclusion Criteria

Exclusion criteria are: siblings aged under four years, no informed consent to participate in the study, insufficient knowledge of the German language.

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Addresses

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Sources of Monetary or Material Support

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    • Jose Carreras-Leukämie-Stiftung
    • Ms.  Ina  Hönninger 
    • Elisabethstraße 23
    • 80796   München
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/06/30
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.