Trial document





This trial has been registered retrospectively.
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  DRKS00003167

Trial Description

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Title

Internet-based program for coping with cancer: a randomized controlled trial with leukemia patients

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Trial Acronym

Internet-based program for coping: randomized controlled trial with leukemia patients

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URL of the Trial

http://www.psychologische-selbsthilfe-leukaemie.de/kursprogramm

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Brief Summary in Lay Language

Psychosocial patient care in oncology is no longer limited to the inpatient setting. Outpatient services are in demand. Internet-based help could aid in optimizing service delivery across disciplines. However, research data on the potential of online programs for coping with cancer is lacking. The objective of the study is to develop and conduct an assessment of an internet-based program to support coping with illness in leukemia under real circumstances for use by patients independent of their place of residence and the location of their hospital. The four-week cognitive behavioral therapy oriented program follows the basic principle of “helping patients help themselves”. The program revolves around two central questions: 1. What coping strategies can help when patients find themselves in situations of acute illness-related stress (e.g., waiting room anxiety)? 2. What strategies are effective in improving the momentary sense of well-being when it is compromised by anticipation of illness-related stress situations (e.g., fear of chemotherapy)?
A research trial is carried out to investigate the effectiveness of the program. It is hypothesized that participants in the program will display improvements in coping in comparison to patients in a waiting list group after four weeks, following conclusion of the intervention program or the waiting period respectively. It is taken as an assumption that the program will be positively assessed and regarded as helpful by a majority of the patients.
A secondary objective is to measure whether participation in the program lead to a reduction in psychological distress.

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Brief Summary in Scientific Language

Psychosocial patient care in oncology is no longer limited to the inpatient setting. Outpatient services are in demand. Internet-based interventions could aid in optimizing service delivery across disciplines. However, empirical data on the potential of internet-based interventions for coping with cancer is lacking. The objective of the study is to develop and conduct a field experimental assessment of an internet-based program to support coping with illness in leukemia for use by patients independent of their place of residence and the location of their hospital. The four-week cognitive behavioral therapy oriented program follows the basic principle of “helping patients help themselves”. The program revolves around two central questions: 1. What coping strategies can help when patients find themselves in situations of acute illness-related stress (e.g., waiting room anxiety)? 2. What strategies are effective in improving the momentary sense of well-being when it is compromised by anticipation of illness-related stress situations (e.g., fear of chemotherapy)? A randomized controlled trial is carried out to investigate the effectiveness of the program. It is hypothesized that participants in the program will display improvements in coping style (MAC) in comparison to patients in a waiting list group after four weeks, following conclusion of the intervention program or the waiting period respectively. It is taken as an assumption that the program will be positively assessed and regarded as helpful by a majority of the patients. A secondary objective is to measure whether participation in the program lead to a reduction in psychological distress (BSI).

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Organizational Data

  •   DRKS00003167
  •   2011/07/04
  •   [---]*
  •   yes
  •   Approved
  •   202/2008BO1, Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
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Secondary IDs

  •   U1111-1122-4884 
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Health Condition or Problem studied

  •   C81-C96 -  Malignant neoplasms, stated or presumed to be primary, of lymphoid, haematopoietic and related tissue
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Interventions/Observational Groups

  •   participation in a four-week internet-based cognitive behavioral therapy oriented intervention program for coping with cancer
  •   waiting list group with participation postponed by four weeks
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   No treatment
  •   Supportive care
  •   Parallel
  •   [---]*
  •   [---]*
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Primary Outcome

Mental adjustment to cancer (fighting spirit, helplessness/hopelessness,anxious preoccupation, fatalism, avoidance) assessed using the Mental Adjustment to Cancer-Scale (MAC).

Assessment at time T1: during registration
Assessment at time T2: following completion of the program or waiting period (after 4 weeks)

All assessments are conducted online.

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Secondary Outcome

Psychological distress assessed using the "Brief Symptom Inventory" (BSI).

Assessment at time T1: during registration
Assessment at time T2: following completion of the program or waiting period (after 4 weeks)

All assessments are conducted online.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2009/07/09
  •   198
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

blood cancer diagnosis, internet access availability

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Exclusion Criteria

None

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Institut für Medizinische Psychologie und Verhaltensneurobiologie, Universität Tübingen
    • Mr.  Prof. Dr.  Wolfgang  Larbig 
    • 74072  Tübingen
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Institut für Medizinische Psychologie und Verhaltensneurobiologie, Universität Tübingen
    • Mr.  Dr.  Niklas  David 
    • Gartenstr. 29
    • 72074  Tübingen
    • Germany
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    • Institut für Medizinische Psychologie und Verhaltensneurobiologie, Universität Tübingen
    • Mr.  Dr.  Niklas  David 
    • Gartenstr. 29
    • 72074  Tübingen
    • Germany
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Sources of Monetary or Material Support

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    • José Carreras Leukämie-Stiftung e.V.
    • Elisabethstraße 23
    • 80796   München
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2010/12/31
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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.