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

Sponsor
University of Leipzig (Other)
Overall Status
Completed
CT.gov ID
NCT02051660
Collaborator
German Cancer Aid (Other), University of Hamburg-Eppendorf (Other), University Health Network, Toronto (Other)
206
Enrollment
2
Locations
2
Arms
57
Actual Duration (Months)
103
Patients Per Site
1.8
Patients Per Site Per Month

Study Details

Study Description

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
  • Behavioral: Manualized CALM intervention
  • Behavioral: Non-manualized supportive intervention.
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
206 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)
Actual Study Start Date :
Mar 1, 2013
Actual Primary Completion Date :
Jun 1, 2017
Actual Study Completion Date :
Dec 1, 2017

Arms and Interventions

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 Names:
  • Managing Cancer and Living Meaning Cancer (CALM)

    		•
    Active Comparator: Non-manualized supportive intervention

    Behavioral: Non-manualized supportive intervention.
    Supportive psycho-oncological intervention.

    Outcome Measures

    Primary Outcome Measures

    1. Depression module of the Patient Health Questionnaire (PHQ-9) [6-months]

      A reliable and valid 9-item measure of depression.

    2. Beck Depression-Inventory II (BDI-II) [6-months]

      A reliable and valid 21-item self-report instrument for evaluating the severity of depression.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Department of Medical Psychology and Medical Sociology, University Medical Center Leipzig Leipzig Saxony Germany 04103
    2 Department of Medical Psychology, University Medical Center Hamburg-Eppendorf Hamburg Germany 20246

    Sponsors and Collaborators

    • University of Leipzig
    • German Cancer Aid
    • University of Hamburg-Eppendorf
    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Anja Mehnert, Prof. Dr. Anja Mehnert, University of Leipzig
    ClinicalTrials.gov Identifier:
    NCT02051660
    Other Study ID Numbers:
    • DKH-110746
    • DKH-109967
    First Posted:
    Jan 31, 2014
    Last Update Posted:
    May 24, 2019
    Last Verified:
    May 1, 2019
    Additional relevant MeSH terms:
    Depression

    Study Results

    No Results Posted as of May 24, 2019