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.
BACKGROUND
Although psycho-oncological interventions have been shown to significantly reduce symptoms of anxiety and depression and enhance quality of life, a substantial number of patients with advanced cancer do not receive psycho-oncological interventions tailored to their individual situation. Given the lack of reliable data on the efficacy of psycho-oncological interventions in palliative care settings, we aim to examine the efficacy of a brief, manualized individual psychotherapy for patients with advanced cancer: Managing Cancer and Living Meaningfully (CALM). CALM aims to reduce depression and death anxiety, to strengthen communication with health care providers, and to enhance hope and meaning in life. We adapted the intervention for German cancer care settings.


METHODS
We use a single-blinded randomized-controlled trial design with two treatment conditions: intervention group (IG, CALM) and control group (CG). Patients in the CG receive a usual non-manualized supportive psycho-oncological intervention (SPI). Patients are randomized between the IG and CG and assessed at baseline (t0), after three (t1) and after 6 months (t2). We include patients with a malignant solid tumor who have tumor stages of III or IV (UICC classification). Patients who are included in the study are at least 18 years old, speak German fluently, score greater than or equal to nine on the PHQ-9 or/and greater than or equal to five on the Distress Thermometer. It is further necessary that there is no evidence of severe cognitive impairments. We measure depression, anxiety, distress, quality of life, demoralization, symptom distress, fatigue as well as spiritual well-being, posttraumatic growth and close relationship experiences using validated questionnaires. We hypothesize that patients in the IG will show a significantly lower level of depression 6 months after baseline compared to patients in the CG. We further hypothesize a significant reduction in anxiety and fatigue as well as significant improvements in psychological and spiritual well-being, meaning and post-traumatic growth in the IG compared to CG 6 months after baseline.


CONCLUSIONS
Our study will contribute important statistical evidence on whether CALM can reduce depression and existential distress in a German sample of advanced and highly distressed cancer patients.


BACKGROUND
ClinicalTrials.gov NCT02051660.
Department and Outpatient Clinic of Medical Psychology, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, Hamburg, 20246, Germany. k.scheffold@uke.de.
Katharina
K
Scheffold
Department and Outpatient Clinic of Medical Psychology, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, Hamburg, 20246, Germany. r.philipp@uke.de.
Rebecca
R
Philipp
Department of Medical Psychology and Medical Sociology, Section of Psychosocial Oncology, University Medical Center Leipzig, Philipp-Rosenthal-Strasse 55, Leipzig, 04103, Germany. dorit.engelmann@medizin.uni-leipzig.de.
Dorit
D
Engelmann
Department and Outpatient Clinic of Medical Psychology, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, Hamburg, 20246, Germany. schulzk@uke.uni-hamburg.de.
Frank
F
Schulz-Kindermann
Department and Outpatient Clinic of Medical Psychology, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, Hamburg, 20246, Germany. c.rosenberger@uke.uni-hamburg.de.
Christina
C
Rosenberger
Department of Oncology, Hematology and Bone Marrow Transplantation with section of Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. k.oechsle@uke.de.
Karin
K
Oechsle
Department and Outpatient Clinic of Medical Psychology, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, Hamburg, 20246, Germany. m.haerter@uke.de.
Martin
M
Härter
Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, Hamburg, 20246, Germany. k.wegscheider@uke.de.
Karl
K
Wegscheider
University Medical Center Leipzig, University Cancer Center Leipzig (UCCL), Liebigstrasse 20, Leipzig, 04103, Germany. florian.lordick@medizin.uni-leipzig.de.
Florian
F
Lordick
Department of Supportive Care, 16-724, Princess Margaret Cancer Centre, 610 University Avenue, Toronto, ON, M5G 2M9, Canada. chrislo@uhnresearch.ca.
Chris
C
Lo
Department of Supportive Care, 16-724, Princess Margaret Cancer Centre, 610 University Avenue, Toronto, ON, M5G 2M9, Canada. sarah.hales@uhn.ca.
Sarah
S
Hales
Department of Supportive Care, 16-724, Princess Margaret Cancer Centre, 610 University Avenue, Toronto, ON, M5G 2M9, Canada. gary.rodin@uhn.ca.
Gary
G
Rodin
Department of Medical Psychology and Medical Sociology, Section of Psychosocial Oncology, University Medical Center Leipzig, Philipp-Rosenthal-Strasse 55, Leipzig, 04103, Germany. anja.mehnert@medizin.uni-leipzig.de.
Anja
A
Mehnert
D001007:Anxiety / Q000628:therapy*; D001293:Attitude to Death; D003863:Depression / Q000628:therapy*; D005858:Germany; D006801:Humans; D009369:Neoplasms / Q000473:pathology / Q000523:psychology*; D010166:Palliative Care; D011614:Psychotherapy, Brief / Q000379:methods*; D011788:Quality of Life; D016037:Single-Blind Method; D016896:Treatment Outcome