German Evaluation of the Effectiveness of the Psychological Intervention Managing Cancer and Living Meaningfully (CALM)
NCT ID: NCT02051660
Last Updated: 2019-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
206 participants
INTERVENTIONAL
2013-03-31
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Manualized CALM Intervention
Manualized CALM intervention
Managing Cancer and Living Meaning Cancer (CALM) is a short-term individual psychotherapy for patients with advanced disease.
Non-manualized supportive intervention
Non-manualized supportive intervention.
Supportive psycho-oncological intervention.
Interventions
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Manualized CALM intervention
Managing Cancer and Living Meaning Cancer (CALM) is a short-term individual psychotherapy for patients with advanced disease.
Non-manualized supportive intervention.
Supportive psycho-oncological intervention.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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German Cancer Aid
OTHER
University of Hamburg-Eppendorf
OTHER
University Health Network, Toronto
OTHER
University of Leipzig
OTHER
Responsible Party
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Anja Mehnert
Prof. Dr. Anja Mehnert
Principal Investigators
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Anja Mehnert, Prof Dr
Role: PRINCIPAL_INVESTIGATOR
University Medical Center of Leipzig
Martin Härter, Prof Dr Dr
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Hamburg-Eppendorf
Locations
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Department of Medical Psychology and Medical Sociology, University Medical Center Leipzig
Leipzig, Saxony, Germany
Department of Medical Psychology, University Medical Center Hamburg-Eppendorf
Hamburg, , Germany
Countries
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References
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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.
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.
Other Identifiers
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DKH-109967
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
DKH-110746
Identifier Type: -
Identifier Source: org_study_id
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