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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by University of Leipzig
Sponsor:
Collaborators:
German Cancer Aid
University of Hamburg
University Health Network, Toronto
Information provided by (Responsible Party):
Anja Mehnert, University of Leipzig
ClinicalTrials.gov Identifier:
NCT02051660
First received: January 29, 2014
Last updated: October 25, 2016
Last verified: October 2016
  Purpose
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 Intervention Phase
Depression
Psychological Distress
Behavioral: Manualized CALM intervention
Behavioral: Non-manualized supportive intervention.
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: German Randomized Controlled Trial of the Psychotherapeutic Intervention for Advanced Cancer Patients: Managing Cancer and Living Meaningfully (CALM)

Resource links provided by NLM:


Further study details as provided by University of Leipzig:

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

  • 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.


Estimated Enrollment: 262
Study Start Date: March 2013
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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 )
Study First Received: January 29, 2014
Last Updated: October 25, 2016

ClinicalTrials.gov processed this record on March 24, 2017