Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
BMC Cancer
Published in: BMC Cancer 1/2015

Open Access 01-12-2015 | Study protocol

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

Authors: Katharina Scheffold, Rebecca Philipp, Dorit Engelmann, Frank Schulz-Kindermann, Christina Rosenberger, Karin Oechsle, Martin Härter, Karl Wegscheider, Florian Lordick, Chris Lo, Sarah Hales, Gary Rodin, Anja Mehnert

Published in: BMC Cancer | Issue 1/2015

Login to get access

Abstract

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/Design

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.

Discussion

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.

Trial registration

ClinicalTrials.gov NCT02051660
Literature
1.
Lozano R, Naghavi M, Foreman K, Lim S, Shibuya K, Aboyans V, et al. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012;380:2095–128.CrossRefPubMed
2.
Delgado-Guay M, Parsons HA, Li Z, Palmer JL, Bruera E. Symptom distress in advanced cancer patients with anxiety and depression in the palliative care setting. Support Care Cancer. 2009;17:573–9.CrossRefPubMed
3.
Oechsle K, Goerth K, Bokemeyer C, Mehnert A. Symptom burden in palliative care patients: perspectives of patients, their family caregivers, and their attending physicians. Support Care Cancer. 2013;21:1955–62.CrossRefPubMed
4.
5.
Götze H, Brähler E, Gansera L, Polze N, Köhler N. Psychological distress and quality of life of palliative cancer patients and their caring relatives during home care. Support Care Cancer. 2014;22:2775–82.CrossRefPubMed
6.
Pringle J, Johnston B, Buchanan D. Dignity and patient-centred care for people with palliative care needs in the acute hospital setting: A systematic review. Palliat Med. 2015;29:675-94.
7.
Ziegler L, Hill K, Neilly L, Bennett MI, Higginson IJ, Murray SA, et al. Identifying psychological distress at key stages of the cancer illness trajectory: a systematic review of validated self-report measures. J Pain Symptom Manage. 2011;41:619–36.CrossRefPubMed
8.
Mehnert A, Brähler E, Faller H, Härter M, Keller M, Schulz H, et al. Four-week prevalence of mental disorders in patients with cancer across major tumor entities. J Clin Oncol. 2014;32:3540–6.
9.
10.
Mitchell AJ, Chan M, Bhatti H, Halton M, Grassi L, Johansen C, et al. Prevalence of depression, anxiety, and adjustment disorder in oncological, haematological, and palliative-care settings: a meta-analysis of 94 interview-based studies. Lancet Oncol. 2011;12:160–74.CrossRefPubMed
11.
Hui D, de La Cruz M, Thorney S, Parsons HA, Delgado-Guay M, Bruera E. The frequency and correlates of spiritual distress among patients with advanced cancer admitted to an acute palliative care unit. Am J Hosp Palliat Me. 2011;28:264–70.
12.
Vehling S, Oechsle K, Koch U, Mehnert A. Receiving palliative treatment moderates the effect of age and gender on demoralization in patients with cancer. PLoS One. 2013;8:e59417.CrossRefPubMedPubMedCentral
13.
Lichtenthal WG, Nilsson M, Zhang B, Trice ED, Kissane DW, Breitbart W, et al. Do rates of mental disorders and existential distress among advanced stage cancer patients increase as death approaches? Psycho-Oncol. 2009;18:50–61.CrossRef
14.
Leung D, Esplen MJ. Alleviating existential distress of cancer patients: can relational ethics guide clinicians? Eur J Cancer Care. 2010;19:30–8.CrossRef
15.
Robinson S, Kissane DW, Brooker J, Burney S. A review of the construct of demoralization: History, definitions, and future directions for palliative care. Am J Hosp Palliat Me. 2014; doi:1049909114553461.
16.
Scheffold K, Mehnert A, Müller V, Koch U, Härter M, Vehling S. Sources of meaning in cancer patients - influences on global meaning, anxiety and depression in a longitudinal study. Eur J Cancer Care. 2014;23:472–80.CrossRef
17.
Faller H, Schuler M, Richard M, Heckl U, Weis J, Kuffner R. Effects of Psycho-Oncologic Interventions on Emotional Distress and Quality of Life in Adult Patients With Cancer: Systematic Review and Meta-Analysis. J Clin Oncol. 2013;31:782–93.CrossRefPubMed
18.
Lemay K, Wilson KG. Treatment of existential distress in life threatening illness: A review of manualized interventions. Clin Psychol Rev. 2008;28:472–93.CrossRefPubMed
19.
van der Spek N, van Uden-Kraan CF, Vos J, Breitbart W, Tollenaar RAEM, van Asperen CJ, et al. Meaning-centered group psychotherapy in cancer survivors: a feasibility study. Psycho-Oncol. 2014;23:827–31.
20.
Lo C, Hales S, Jung J, Chiu A, Panday T, Rydall A, et al. Managing Cancer And Living Meaningfully (CALM): Phase 2 trial of a brief individual psychotherapy for patients with advanced cancer. Palliat Med. 2014;28:234–42.
21.
Breitbart W, Rosenfeld B, Pessin H, Applebaum A, Kulikowski J, Lichtenthal WG. Meaning-centered group psychotherapy: an effective intervention for improving psychological well-being in patients with advanced cancer. J Clin Oncol. 2015;33:749–54.CrossRefPubMedPubMedCentral
22.
Creamer M, Burgess P, Pattison P. Reaction to trauma: A cognitive processing model. J Abnorm Psychol. 1992;101:452–9.CrossRefPubMed
23.
Chochinov HM, Hack T, Hassard T, Kristjanson LJ, McClement S, Harlos M. Dignity and psychotherapeutic considerations in end-of-life care. J Palliat Care. 2004;20:134–42.PubMed
24.
Kissane D. Beyond the psychotherapy and survival debate: the challenge of social disparity, depression and treatment adherence in psychosocial cancer care. Psycho-Oncol. 2009;18:1–5.CrossRef
25.
Rodin G, Lo C, Mikulincer M, Donner A, Gagliese L, Zimmermann C. Pathways to distress: The multiple determinants of depression, hopelessness, and the desire for hastened death in metastatic cancer patients. Soc Sci Med. 2009;68:562–9.CrossRefPubMed
26.
Nissim R, Freeman E, Lo C, Zimmermann C, Gagliese L, Rydall A, et al. Managing Cancer and Living Meaningfully (CALM): A qualitative study of a brief individual psychotherapy for individuals with advanced cancer. Palliat Med. 2012;26:713–21.
27.
Spitzer RL, Kroenke K, Williams JB. Valiation and utility of a self-report version of PRIME-MD: The PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA. 1999;282:1737–44.CrossRefPubMed
28.
Löwe B, Spitzer RL, Zipfel S, Herzog W. PRIME MD Patient Health Questionnaire (PHQ) - German version. Manual and materials. 2nd edition. Karlsruhe: Pfitzer; 2002
29.
Löwe B, Kroenke K, Herzog W, Gräfe K. Measuring depression outcome with a brief self-report instrument: sensitivity to change of the Patient Health Questionnaire (PHQ-9). J Affect Disord. 2004;81:61–6.CrossRefPubMed
30.
Mehnert A, Müller D, Lehmann C, Koch U. Die deutsche Version des NCCN Distress-Thermometers. Z Psychiatr Psych Ps. 2006;54:213–23.
31.
Katzman R, Brown T, Fuld P, Peck A, Schechter R, Schimmel H. Validation of a Short-Memory-Concentration-Test of cognitive impairment. Am J Psychiat. 1983;140:734–9.CrossRefPubMed
32.
Wade D, Vergis S. The Short Orientation-Memory-Concentration Test: a study of its reliability and validity. Clin Rehabil. 1999;13:164–70.
33.
Wittchen HU, Wunderlich U, Gruschwitz S, Zaudig M. SKID-I. Strukturiertes Klinisches Interview für DSM-IV. Achse I: Psychische Störungen. Interviewheft. Göttingen: Hogrefe; 1997.
34.
Evans C, Mccarthy M. Prognostic uncertainty in terminal care: Can the Karnofsky Index help? Lancet. 1985;325:1204–6.
35.
Kaasa S, Loge J. Quality of life in palliative care: principles and practice. Palliat Med. 2003;17:11–20.CrossRefPubMed
36.
Lo C, Hales S, Rydall A, Panday T, Chiu A, Malfitano C, Jung J, Li M, Nissim R, Zimmermann C, Rodin G. Managing Cancer And Living Meaningfully: study protocol for a randomized controlled trial. Trials. 2015; doi: 10.1186/s13063-015-0811-1.
37.
Hales S, Lo C, Rodin G. Managing Cancer and Living Meaningfully (CALM): Treatment Manual: An individual psychotherapy for patients with advanced cancer. Toronto: Psychosocial Oncology and Palliative Care. Princess Margaret Hospital, University Health Network; 2010.
38.
Löwe B, Graefe K, Zipfel S, Witte S, Loerch B, Herzog W. Diagnosing ICD-10 depressive episodes: Superior criterion validity of the Patient Health Questionnaire. Psychother Psychosom. 2004;73:386–90.
39.
Rief W, Nanke A, Klaiberg A, Braehler E. Base rates for panic and depression according to the Brief Patient Health Questionnaire: a population-based study. J Affect Disord. 2004;82:271–6.CrossRefPubMed
40.
Hautzinger M, Keller F, Kühner C. BDI-II. Beck Depressions Inventar Revision – Manual. Frankfurt: Harcourt Test Services; 2006.
41.
Kühner C, Bürger C, Keller F, Hautzinger M. Reliabilität und Validität des revidierten Beck-Depressionsinventars (BDI-II). Nervenarzt. 2007;78:651–6.CrossRefPubMed
42.
Spitzer RL, Kroenke K, Williams JBW, Löwe B. A brief measure for assessing Generalized Anxiety Disorder. Arch Intern Med. 2006;166:1092–7.CrossRefPubMed
43.
Löwe B, Decker O, Müller S, Brähler E, Schellberg D, Herzog W, et al. Validation and standardization of the Generalized Anxiety Disorder Screener (GAD-7) in the general population. Med Care. 2008;46:266–74.
44.
Kissane D, Wein S, Love A, Lee X, Kee P, Clarke DM. The Demoralization Scale: a report of its developement and preliminary validation. J Palliat Care. 2004;20:269–76.PubMed
45.
Mehnert A, Vehling S, Höcker A, Lehmann C, Koch U. Demoralization and Depression in Patients With Advanced Cancer: Validation of the German Version of the Demoralization Scale. J Pain Symptom Manag. 2011;42:768–76.CrossRef
46.
Kissane DW, Clarke DM, Street AF. Demoralization Syndrome - a relevant psychiatric diagnosis for palliative care. J Palliat Care. 2001;17:12–21.PubMed
47.
Mendoza TR, Wang XS, Cleeland C, Morrissey M, Johnson BA, Wendt JK, et al. The rapid assessment of fatigue severity in cancer patients. Cancer. 1999;85:1186–96.
48.
Radbruch L, Sabatowski R, Elsner F, Everts J, Mendoza T, Cleeland C. Validation of the German Version of the Brief Fatigue Inventory. J Pain Symptom Manag. 2003;25:449–58.CrossRef
49.
Portenoy R, Thaler H, Kornblith A, McCarthy Lepore J, Friedlander-Klar H, Kiyasu E, et al. The Memorial Symptom Assessment Scale: an instrument for the evaluation of symptom prevalence, characteristics and distress. Eur J Cancer. 1994;30:1326–36.
50.
Chang VT, Hwang SS, Feuerman M, Kasimis BS, Thaler HT. The Memorial Symptom Assessment Scale Short Form (MSAS-SF): Validity and reliability. Cancer. 2000;89:1162–71.CrossRefPubMed
51.
Peterman AH, Fitchett G, Brady MJ, Hernandez L, Cella DF. Measuring spiritual well-being in people with cancer: The functional assessment of chronic illness therapy-spiritual well-being scale (FACIT-Sp). Ann Behav Med. 2002;24:49–58.CrossRefPubMed
52.
Lo C, Hales S, Zimmermann C, Gagliese L, Rydall A, Rodin G. Measuring death-related anxiety in advanced cancer: preliminary psychometrics of the Death and Dying Distress Scale. J Pediatr Hematol Oncol. 2011;33:S140–5.CrossRefPubMed
53.
Krause S, Rydall A, Hales S, Rodin G, Lo C. Initial validation of the Death and Dying Distress Scale for the assessment of death anxiety in patients with advanced cancer. J Pain Symptom Manage. 2015;49:126–34.CrossRefPubMed
54.
Tedeschi RG, Calhoun LG. The Posttraumatic Growth Inventory: measuring the positive legacy of trauma. J Trauma Stress. 1996;9:455–71.CrossRefPubMed
55.
Maercker A, Langner R. Persönliche Reifung (personal growth) durch Belastungen und Traumata: Validierung zweier deutschsprachiger Fragebogenversionen. Diagnostica. 2001;47:153–62.CrossRef
56.
Brennan KA, Clark CL, Shaver PR. Self-report measurement of adult attachment. An integrative overview. In: Simpson JA, Rholes WS, editors. Attachment theory and close relationships. New York, NY: Guilford; 1998. p. 46–76.
57.
Lo C, Walsh A, Mikulincer M, Gagliese L, Zimmermann C, Rodin G. Measuring attachment security in patients with advanced cancer: psychometric properties of a modified and brief Experiences in Close Relationships scale. Psycho-Oncol. 2009;18:490–9.CrossRef
58.
Lo C, Burman D, Swami N, Gagliese L, Rodin G, Zimmermann C. Validation of the QUAL-EC for assessing quality of life in patients with advanced cancer. Eur J Cancer. 2011;47:554–60.CrossRefPubMed
59.
Olso DH, Larson PJ, Olson-Sigg A. Couple Checkup: Tuning up relationships. J Couple Rel Therap. 2009;8:129–42.CrossRef
60.
61.
Borm GF, Fransen J, Lemmens WA. A simple sample size formula for analysis of covariance in randomized clinical trials. J Clin Epidemol. 2007;60:1234–8.CrossRef
62.
Cohen J. Statistical Power Analysis for the Behavioral Sciences. 2nd ed. Hillsdale: Lawrence Erlbaum Associates; 1988.
63.
Meinert CL. Clinical Trials: Design, Conduct and Analysis. Oxford: Oxford University Press; 1986.CrossRef
64.
Lachin JM. Introduction to sample size determination and power analysis for clinical trials. Control Clin Trials. 1981;2:93–113.CrossRefPubMed
65.
Ell K, Xie B, Quon B, Quinn DI, Dwight-Johnson M, Lee P. Randomized Controlled Trial of Collaborative Care Management of Depression Among Low-Income Patients With Cancer. J Clin Oncol. 2008;26:4488–96.CrossRefPubMedPubMedCentral
66.
Strong V, Waters R, Hibberd C, Murray G, Wall L, Walker J, et al. Management of depression for people with cancer (SMaRT oncology 1): a randomised trial. Lancet. 2008;372:40–8.
67.
Metadata
Title
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
Authors
Katharina Scheffold
Rebecca Philipp
Dorit Engelmann
Frank Schulz-Kindermann
Christina Rosenberger
Karin Oechsle
Martin Härter
Karl Wegscheider
Florian Lordick
Chris Lo
Sarah Hales
Gary Rodin
Anja Mehnert
Publication date
01-12-2015
Publisher
BioMed Central
Published in
BMC Cancer / Issue 1/2015
Electronic ISSN: 1471-2407
DOI
https://doi.org/10.1186/s12885-015-1589-y

Other articles of this Issue 1/2015

BMC Cancer 1/2015 Go to the issue

Research article

Prognostic value of inhibitors of apoptosis proteins (IAPs) and caspases in prostate cancer: caspase-3 forms and XIAP predict biochemical progression after radical prostatectomy

Research article

DKK1 is a potential novel mediator of cisplatin-refractoriness in non-small cell lung cancer cell lines

Research article

Tumour shrinkage at 6 weeks predicts favorable clinical outcomes in a phase III study of gemcitabine and oxaliplatin with or without erlotinib for advanced biliary tract cancer

Research article

RUNX1-Evi-1 fusion gene inhibited differentiation and apoptosis in myelopoiesis: an in vivo study

Research article

High expression of AGR2 in lung cancer is predictive of poor survival

Research article

Phase II study of axitinib with doublet chemotherapy in patients with advanced squamous non–small-cell lung cancer
Webinar | 19-02-2024 | 17:30 (CET)

Keynote webinar | Spotlight on antibody–drug conjugates in cancer

Watch now

Antibody–drug conjugates (ADCs) are novel agents that have shown promise across multiple tumor types. Explore the current landscape of ADCs in breast and lung cancer with our experts, and gain insights into the mechanism of action, key clinical trials data, existing challenges, and future directions.

Dr. Véronique Diéras
Prof. Fabrice Barlesi
Developed by: Springer Medicine
Image Credits