Clinical trial · Interventional
German Evaluation of the Effectiveness of the Psychological Intervention Managing Cancer and Living Meaningfully (CALM)
German Randomized Controlled Trial of the Psychotherapeutic Intervention for Advanced Cancer Patients: Managing Cancer and Living Meaningfully (CALM)
NCT02051660CI-TRIAL-00038787completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Depression | — | UNRESOLVED | — |
| Psychological Distress | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Manualized CALM intervention | Behavioral | — | UNRESOLVED |
| Non-manualized supportive intervention. | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Manualized CALM Intervention
- interventionNames
- Behavioral: Manualized CALM intervention
- type
- ACTIVE_COMPARATOR
- label
- Non-manualized supportive intervention
- interventionNames
- Behavioral: Non-manualized supportive intervention.
Primary outcomes (2)
- measure
- Depression module of the Patient Health Questionnaire (PHQ-9)
- timeFrame
- 6-months
- description
- A reliable and valid 9-item measure of depression.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDScheffold 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. PMID 30887126
- DERIVEDScheffold 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. PMID 26286128