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

May 23, 2019 updated by: Anja Mehnert, University of Leipzig

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

206

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20246
        • Department of Medical Psychology, University Medical Center Hamburg-Eppendorf
    • Saxony
      • Leipzig, Saxony, Germany, 04103
        • Department of Medical Psychology and Medical Sociology, University Medical Center Leipzig

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression module of the Patient Health Questionnaire (PHQ-9)
Time Frame: 6-months
A reliable and valid 9-item measure of depression.
6-months
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.
6-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leipzig

Collaborators

University Health Network, Toronto
University of Hamburg-Eppendorf
German Cancer Aid

Investigators

  • Principal Investigator: Anja Mehnert, Prof Dr, University Medical Center of Leipzig
  • Principal Investigator: Martin Härter, Prof Dr Dr, Universitätsklinikum Hamburg-Eppendorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2013

Primary Completion (ACTUAL)

June 1, 2017

Study Completion (ACTUAL)

December 1, 2017

Study Registration Dates

First Submitted

January 29, 2014

First Submitted That Met QC Criteria

January 29, 2014

First Posted (ESTIMATE)

January 31, 2014

Study Record Updates

Last Update Posted (ACTUAL)

May 24, 2019

Last Update Submitted That Met QC Criteria

May 23, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DKH-110746
  • DKH-109967 (OTHER_GRANT: German Cancer Aid)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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