Trial document




drksid header

  DRKS00000731

Trial Description

start of 1:1-Block title

Title

Occupational integration, everyday life management and well-being after childhood cancer

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

While most survivors of childhood cancer are psychologically and socially well adjusted, a significant subgroup of survivors experiences relevant levels of psychological distress. The goal of our questionnaire study is to describe the psychological well-being of young adult childhood cancer survivors and to examine the relation between ways of coping and psychological well-being. Participants are recruited from the patient data base of the Division of Pediatric Hematology and Oncology, University Medical Center Freiburg, Germany. Former patients who are at least 5 years off therapy are contacted by mail and are asked to complete questionnaires assessing health information, psychological well-being and different ways of coping. The results will provide information for professionals offering psychosocial services at the newly established follow-up clinic for adult childhood cancer survivors at the University Medical Center Freiburg.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

While most survivors of childhood cancer are psychologically and socially well adjusted, a significant subgroup of survivors experiences relevant levels of psychological distress. The goal of this postal questionnaire study is to describe the prevalence of symptoms of psychological distress in young adult childhood cancer survivors and the association of cognitive coping with this psychological distress. Participants are recruited from the patient data base of the Devision of Pediatric Hematology and Oncology, University Medical Center Freiburg, Germany. Adult childhood cancer survivors who are at least 5 years off therapy complete questionnaires assessing demographics, health information, psychosocial adjustment and post-traumatic stress symptoms as well as illness cognitions and different ways of coping. The study aims at contributing to a better understanding of the correlates of difficulties in long-term psychosocial adjustment after childhood cancer.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00000731
  •   2011/02/24
  •   2008/02/06
  •   yes
  •   Approved
  •   030/08, Ethik-Kommission der Albert-Ludwig-Universität Freiburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   UKF001443  (Register Klinischer Studien des Universitätsklinikums Freiburg)
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   childhood cancer
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Screening study: no intervention; focus of analyses are relations among variables; see "endpoints" for assessed variables
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Screening
  •   Single (group)
  •   N/A
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Primary outcomes are psychological well-being and coping. Main goals of the study are the assessment of psychological well-being (screening/description of study group) and the analysis of relations between different ways of coping and psychological well-being.

Both endpoints are assessed at the same time. They are operationalized by the following questionnaires/items:

Psychological Well-being:
-Brief Symptom Inventory 18 (Derogatis 2000)
-Posttraumatic Stress Diagnostic Scale, 8 Item Version (Ehring et al. 2007)


Coping:
-Cognitive Control Strategy Scale (Stam et al., 2006)
-White Bear Suppression Scale (Wegner & Zanakos, 1994)
-Illness Perception Scale-Revised (Moss-Morris et al., 2002)
-Subjective Risk Perception
-Perceived positive consequences/benefits

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Secondary outcome variables are sociodempgraphic information/social adaptation, medical late effects, general distress, social support, and body image.

Secondary outcome variabels are assessed at the same time point as primary outcomes. The following questionnaires are used:
-Questionnaire on sociodemographic and health information
-Distress Thermometer (Holland & Reznik, 2005)
-Questionnaire on Social Support, 14 Item Shortform (Fydrich, Sommer & Brähler, 2007)
-Body Image Questionnaire (Wenninger et al., 2003)

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • [---]*
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2008/09/11
  •   400
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

cancer diagnosis in childhood, at time of study at least 18 years old, at least 5 years off therapy, signed informed consent

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

not able to read and write German

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Freiburg, Zentrum für Kinder- und Jugendmedizin, Klinik IV: Pädiatrische Hämatologie und Onkologie
    • Ms.  Prof. Dr.  Charlotte  Niemeyer 
    • Mathildenstr. 1
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universitätsklinikum Freiburg Zentrum für Kinder- und Jugendmedizin - Pädiatrische Hämatologie und Onkologie
    • Ms.  Dr. rer. nat.  Kerstin  Wenninger 
    • Mathildenstr. 1
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitätsklinikum Freiburg Zentrum für Kinder- und Jugendmedizin - Pädiatrische Hämatologie und Onkologie
    • Ms.  Dr. rer. nat.  Kerstin  Wenninger 
    • Mathildenstr. 1
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Universitätsklinikum Freiburg Zentrum für Kinder- und Jugendmedizin - Pädiatrische Hämatologie und Onkologie
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting suspended on temporary hold
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.