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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Depression, Psychological Distress

Intervention / Treatment
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* Behavioral: Manualized CALM intervention
* Behavioral: Non-manualized supportive intervention.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Manualized CALM Intervention<br> | Behavioral: Manualized CALM intervention<br>* Managing Cancer and Living Meaning Cancer (CALM) is a short-term individual psychotherapy for patients with advanced disease.<br>* Other names: Managing Cancer and Living Meaning Cancer (CALM);|
| Active Comparator: Non-manualized supportive intervention<br> | Behavioral: Non-manualized supportive intervention.<br>* Supportive psycho-oncological intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression module of the Patient Health Questionnaire (PHQ-9) | A reliable and valid 9-item measure of depression. | 6-months | 
| Beck Depression-Inventory II (BDI-II) | A reliable and valid 21-item self-report instrument for evaluating the severity of depression. | 6-months |