Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005873

Trial Description

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Title

German Randomized Controlled Trial of the Psychotherapeutic Intervention for Advanced Cancer Patients: Managing Cancer and Living Meaningfully (CALM)

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Purpose of this randomized controlled trial is to test the efficacy of the individual
psychotherapeutic intervention Managing Cancer and Living Meaningfully (CALM) in a German
sample of patients with advanced cancer. The interventions aim is to reduce depression and
distress and support psychological well-being.

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Brief Summary in Scientific Language

Principal hypothesis: The manualized psychotherapeutic intervention (CALM) will result in a
significantly greater reduction in depression and psychological distress compared to a
non-manualized supportive psycho-oncological intervention. Secondary hypothesis: The
manualized psychotherapeutic intervention (CALM) will further result in a significantly
improve psychological well-being, quality of life and sense of meaning compared to a
non-manualized supportive psycho-oncological intervention.

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Organizational Data

  •   DRKS00005873
  •   2014/09/12
  •   2014/01/29
  •   yes
  •   [---]*
  •   [---]*
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Secondary IDs

  •   NCT02051660  (ClinicalTrials.gov)
  •   DKH-110746  (University of Leipzig)
  •   DKH-109967 
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Health Condition or Problem studied

  •   Depression
  •   Psychological Distress
  •   F32 -  Depressive episode
  •   F43.0 -  Acute stress reaction
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Interventions/Observational Groups

  •   Behavioral: Manualized CALM intervention
  •   Behavioral: Non-manualized supportive intervention.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Active control
  •   Treatment
  •   Parallel
  •   III
  •   [---]*
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Primary Outcome

- Patient Health Questionnaire-9 (PHQ-9); time frame: 6-months; A reliable and valid 9-item measure of depression.

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
  •  
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Recruitment

  •   [---]*
  •   2013/03/31
  •   262
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

- ≥18 years of age

- Fluency in German

- No cognitive impairment indicated in the medical record or by the attending
oncologist

- Confirmed diagnosis of solid tumors with UICC (Union Internationale Contre le Cancer)
stages III/IV/ metastasized cancer (all with expected survival of 12-18 months)

- PHQ-9 depression score >=9 or Distress thermometer score >=5

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Exclusion Criteria

- Major communication difficulties (including language barriers)

- Inability to commit to the required 3-6 psychotherapy sessions

- A score <20 on the Short Orientation-Memory-Concentration (SOMC) test, indicating
cognitive impairment unless deemed suitable at recruiter's discretion

- A score <70 on the Karnofsky-Performance Status Scale, indicating high physical
symptom burden impeding study participation

- Being in psychotherapy

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Addresses

  • start of 1:1-Block address primary-sponsor
    • University of Leipzig
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    •   [---]*
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    • German Cancer Aid
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    •   [---]*
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    • Universitätsklinikum Hamburg-Eppendorf
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    •   [---]*
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    • University Health Network, Toronto
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    •   [---]*
    •   [---]*
    •   [---]*
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    • University Medical Center of Leipzig
    • Anja Mehnert, Prof Dr 
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    •   [---]*
    •   [---]*
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    • Anja Mehnert, PhD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
    •   [---]*
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   2
  •   2014/11/27
* This entry means the parameter is not applicable or has not been set.