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German Evaluation of the Effectiveness of the Psychological Intervention Managing Cancer and Living Meaningfully (CALM)

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ClinicalTrials.gov Identifier: NCT02051660
Recruitment Status : Recruiting
First Posted : January 31, 2014
Last Update Posted : October 26, 2016
Sponsor:
Collaborators:
German Cancer Aid
University of Hamburg
University Health Network, Toronto
Information provided by (Responsible Party):
Anja Mehnert, University of Leipzig

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Depression Psychological Distress Behavioral: Manualized CALM intervention Behavioral: Non-manualized supportive intervention. Phase 3

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 262 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: German Randomized Controlled Trial of the Psychotherapeutic Intervention for Advanced Cancer Patients: Managing Cancer and Living Meaningfully (CALM)
Study Start Date : March 2013
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Manualized CALM Intervention Behavioral: Manualized CALM intervention
Managing Cancer and Living Meaning Cancer (CALM) is a short-term individual psychotherapy for patients with advanced disease.
Other Name: Managing Cancer and Living Meaning Cancer (CALM)
Active Comparator: Non-manualized supportive intervention Behavioral: Non-manualized supportive intervention.
Supportive psycho-oncological intervention.



Primary Outcome Measures :
  1. Depression module of the Patient Health Questionnaire (PHQ-9) [ Time Frame: 6-months ]
    A reliable and valid 9-item measure of depression.

  2. Beck Depression-Inventory II (BDI-II) [ Time Frame: 6-months ]
    A reliable and valid 21-item self-report instrument for evaluating the severity of depression.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02051660


Contacts
Contact: Anja Mehnert, PhD ++49 (0)341-97-15414 anja.mehnert@medizin.uni-leipzig.de
Contact: Martin Härter, PhD, MD ++49 (0)40-7410-52978 m.haerter@uke.de

Locations
Germany
Department of Medical Psychology and Medical Sociology, University Medical Center Leipzig Recruiting
Leipzig, Saxony, Germany, 04103
Contact: Dorit Engelmann, Dipl-Psych    ++49 (0)341 - 9715458    dorit.engelmann@medizin.uni-leipzig.de   
Principal Investigator: Anja Mehnert, PhD         
Department of Medical Psychology, University Medical Center Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Katharina Scheffold, Msc    ++49 (0)40 7410-56203    k.scheffold@uke.de   
Principal Investigator: Martin Härter, PhD, MD         
Sponsors and Collaborators
University of Leipzig
German Cancer Aid
University of Hamburg
University Health Network, Toronto
Investigators
Principal Investigator: Anja Mehnert, Prof Dr University Medical Center of Leipzig
Principal Investigator: Martin Härter, Prof Dr Dr Universitätsklinikum Hamburg-Eppendorf

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anja Mehnert, Prof. Dr. Anja Mehnert, University of Leipzig
ClinicalTrials.gov Identifier: NCT02051660     History of Changes
Other Study ID Numbers: DKH-110746
DKH-109967 ( Other Grant/Funding Number: German Cancer Aid )
First Posted: January 31, 2014    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016