German Randomized Controlled Trial of the Psychotherapeutic Intervention for Advanced Cancer Patients: Managing Cancer and Living Meaningfully (CALM)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 206
- Locations
- 2
- Primary Endpoint
- Beck Depression-Inventory II (BDI-II)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Manualized CALM Intervention
Intervention: Manualized CALM intervention (Behavioral)
Non-manualized supportive intervention
Intervention: Non-manualized supportive intervention. (Behavioral)
Outcomes
Primary Outcomes
Beck Depression-Inventory II (BDI-II)
Time Frame: 6-months
A reliable and valid 21-item self-report instrument for evaluating the severity of depression.
Depression module of the Patient Health Questionnaire (PHQ-9)
Time Frame: 6-months
A reliable and valid 9-item measure of depression.
Secondary Outcomes
No secondary outcomes reported
Investigators
Anja Mehnert
Prof. Dr. Anja Mehnert
University of Leipzig