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

Study Protocol

Rebecca Philipp¹  Frank Schulz-Kindermann¹  Katharina Scheffold¹  Martin Härter¹  Christina Rosenberger¹  Karl Wegscheider²  Anja Mehnert³  Dorit Engelmann³  Karin Oechsle⁴  Sarah Hales⁵  Gary Rodin⁵  Chris Lo⁵  Florian Lordick⁶ 

[1] Department and Outpatient Clinic of Medical Psychology, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246, Hamburg, Germany;Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246, Hamburg, Germany;Department of Medical Psychology and Medical Sociology, Section of Psychosocial Oncology, University Medical Center Leipzig, Philipp-Rosenthal-Strasse 55, 04103, Leipzig, Germany;Department of Oncology, Hematology and Bone Marrow Transplantation with section of Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany;Department of Supportive Care, 16-724, Princess Margaret Cancer Centre, 610 University Avenue, M5G 2M9, Toronto, ON, Canada;University Medical Center Leipzig, University Cancer Center Leipzig (UCCL), Liebigstrasse 20, 04103, Leipzig, Germany;

关键词: Palliative Care;    High Internal Consistency;    Posttraumatic Growth;    Distress Thermometer;    Death Anxiety;   

DOI  :  10.1186/s12885-015-1589-y

 received in 2015-06-11, accepted in 2015-07-30,  发布年份 2015

来源: Springer

【 摘 要 】

BackgroundAlthough 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/DesignWe 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.DiscussionOur 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.Trial registrationClinicalTrials.gov NCT02051660

【 授权许可】

CC BY   
© Scheffold et al. 2015