Back to resultsGerman Evaluation of the Effectiveness of the Psychological Intervention Managing Cancer and Living Meaningfully (CALM)
Primary Purpose
Depression, Psychological Distress
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Manualized CALM intervention
Non-manualized supportive intervention.
Sponsored by
About this trial
This is an interventional treatment trial for Depression
Eligibility 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
Sites / Locations
- Department of Medical Psychology and Medical Sociology, University Medical Center Leipzig
- Department of Medical Psychology, University Medical Center Hamburg-Eppendorf
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Manualized CALM Intervention
Non-manualized supportive intervention
Arm Description
Outcomes
Primary Outcome Measures
Depression module of the Patient Health Questionnaire (PHQ-9)
A reliable and valid 9-item measure of depression.
Beck Depression-Inventory II (BDI-II)
A reliable and valid 21-item self-report instrument for evaluating the severity of depression.
Secondary Outcome Measures
Full Information
NCT ID
NCT02051660
First Posted
January 29, 2014
Last Updated
May 23, 2019
Sponsor
University of Leipzig
Collaborators
German Cancer Aid, University of Hamburg-Eppendorf, University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT02051660
Brief Title
German Evaluation of the Effectiveness of the Psychological Intervention Managing Cancer and Living Meaningfully (CALM)
Official Title
German Randomized Controlled Trial of the Psychotherapeutic Intervention for Advanced Cancer Patients: Managing Cancer and Living Meaningfully (CALM)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
March 2013 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Leipzig
Collaborators
German Cancer Aid, University of Hamburg-Eppendorf, University Health Network, Toronto
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Psychological Distress
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
206 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Manualized CALM Intervention
Arm Type
Experimental
Arm Title
Non-manualized supportive intervention
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Manualized CALM intervention
Other Intervention Name(s)
Managing Cancer and Living Meaning Cancer (CALM)
Intervention Description
Managing Cancer and Living Meaning Cancer (CALM) is a short-term individual psychotherapy for patients with advanced disease.
Intervention Type
Behavioral
Intervention Name(s)
Non-manualized supportive intervention.
Intervention Description
Supportive psycho-oncological intervention.
Primary Outcome Measure Information:
Title
Depression module of the Patient Health Questionnaire (PHQ-9)
Description
A reliable and valid 9-item measure of depression.
Time Frame
6-months
Title
Beck Depression-Inventory II (BDI-II)
Description
A reliable and valid 21-item self-report instrument for evaluating the severity of depression.
Time Frame
6-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anja Mehnert, Prof Dr
Organizational Affiliation
University Medical Center of Leipzig
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martin Härter, Prof Dr Dr
Organizational Affiliation
Universitätsklinikum Hamburg-Eppendorf
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medical Psychology and Medical Sociology, University Medical Center Leipzig
City
Leipzig
State/Province
Saxony
ZIP/Postal Code
04103
Country
Germany
Facility Name
Department of Medical Psychology, University Medical Center Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
30887126
Citation
Scheffold K, Philipp R, Vehling S, Koranyi S, Engelmann D, Schulz-Kindermann F, Harter M, Mehnert-Theuerkauf A. Spiritual well-being mediates the association between attachment insecurity and psychological distress in advanced cancer patients. Support Care Cancer. 2019 Nov;27(11):4317-4325. doi: 10.1007/s00520-019-04744-x. Epub 2019 Mar 18.
Results Reference
derived
PubMed Identifier
26286128
Citation
Scheffold K, Philipp R, Engelmann D, Schulz-Kindermann F, Rosenberger C, Oechsle K, Harter M, Wegscheider K, Lordick F, Lo C, Hales S, Rodin G, Mehnert A. Efficacy of a brief manualized intervention Managing Cancer and Living Meaningfully (CALM) adapted to German cancer care settings: study protocol for a randomized controlled trial. BMC Cancer. 2015 Aug 19;15:592. doi: 10.1186/s12885-015-1589-y.
Results Reference
derived
Learn more about this trial
German Evaluation of the Effectiveness of the Psychological Intervention Managing Cancer and Living Meaningfully (CALM)
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