Clinical trial NCT02051660: 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
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Psychological Distress
Lead sponsor: University of Leipzig
Sponsor class: OTHER
Collaborators: name: German Cancer Aid
name: University of Hamburg-Eppendorf
name: University Health Network, Toronto
First posted: 2014-01-31
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Depression module of the Patient Health Questionnaire (PHQ-9)
timeFrame: 6-months
measure: Beck Depression-Inventory II (BDI-II)
timeFrame: 6-months
Secondary outcomes:
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Department of Medical Psychology and Medical Sociology, University Medical Center Leipzig
state: Saxony
city: Hamburg
country: Germany
facility: Department of Medical Psychology, University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: University Medical Center of Leipzig
name: Anja Mehnert, Prof Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Martin Härter, Prof Dr Dr
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.