NCT02051660

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
206

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable depression

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 31, 2014

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 24, 2019

Status Verified

May 1, 2019

Enrollment Period

4.3 years

First QC Date

January 29, 2014

Last Update Submit

May 23, 2019

Conditions

DepressionPsychological Distress

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Manualized CALM Intervention

EXPERIMENTAL
Behavioral: Manualized CALM intervention

Non-manualized supportive intervention

ACTIVE COMPARATOR
Behavioral: Non-manualized supportive intervention.

Interventions

Manualized CALM interventionBEHAVIORAL

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

Also known as: Managing Cancer and Living Meaning Cancer (CALM)
Manualized CALM Intervention
Non-manualized supportive intervention.BEHAVIORAL

Supportive psycho-oncological intervention.

Non-manualized supportive intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Leipzig, Saxony, 04103, Germany

Location

Department of Medical Psychology, University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Related Publications (2)

  • 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.

    PMID: 30887126DERIVED

  • 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.

    PMID: 26286128DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Anja Mehnert, Prof Dr

    University Medical Center of Leipzig

    PRINCIPAL INVESTIGATOR

  • Martin Härter, Prof Dr Dr

    Universitätsklinikum Hamburg-Eppendorf

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Anja Mehnert

Study Record Dates

First Submitted

January 29, 2014

First Posted

January 31, 2014

Study Start

March 1, 2013

Primary Completion

June 1, 2017

Study Completion

December 1, 2017

Last Updated

May 24, 2019

Record last verified: 2019-05

Locations

DE(2)