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Completed

NCT Number: NCT02051660

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

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Psychological Distress

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Medical Psychology and Medical Sociology, University Medical Center Leipzig, Leipzig, Saxony, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Manualized CALM intervention

Behavioral

Managing Cancer and Living Meaning Cancer (CALM) is a short-term individual psychotherapy for patients with advanced disease.

Other names: Managing Cancer and Living Meaning Cancer (CALM)

Non-manualized supportive intervention.

Behavioral

Supportive psycho-oncological intervention.

Primary outcomes

  1. Depression module of the Patient Health Questionnaire (PHQ-9)

    Time frame: 6-months

    A reliable and valid 9-item measure of depression.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Collaborators

  • German Cancer Aid
  • University Health Network, Toronto
  • University of Hamburg-Eppendorf

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jan 31, 2014
Registry last updated
May 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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