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

Volumn 15, Issue 1, 2015, Pages

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

^a UNIVERSITY MEDICAL CENTER HAMBURG EPPENDORF   (Germany)

^b UNIVERSITY HOSPITAL LEIPZIG   (Germany)

^c PRINCESS MARGARET HOSPITAL   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; ANXIETY ASSESSMENT; ARTICLE; BECK DEPRESSION INVENTORY; BRIEF FATIGUE INVENTORY; CLINICAL EFFECTIVENESS; CLINICAL EVALUATION; COGNITIVE DEFECT; CONTROLLED STUDY; COUPLE COMMUNICATION SCALE; DEATH AND DYING DISTRESS SCALE; DEMORALIZATION; DEMORALIZATION SCALE; DISEASE SEVERITY; DISTRESS SYNDROME; DISTRESS THERMOMETER; DSM-IV; EXPERIENCES IN CLOSE RELATIONSHIPS SCALE; FATIGUE; FUNCTIONAL ASSESSMENT OF CHRONIC ILLNESS THERAPY SPIRITUAL WELL BEING SCALE; GENERALIZED ANXIETY DISORDER; GENERALIZED ANXIETY DISORDER QUESTIONNAIRE; GERMAN (CITIZEN); HUMAN; LEARNING AND MEMORY TEST; MAJOR DEPRESSION; MANAGING CANCER AND LIVING MEANINGFULLY; MANIPULATIVE MEDICINE; MEMORIAL SYMPTOM ASSESSMENT SCALE; PATIENT HEALTH QUESTIONNAIRE 9; POSTTRAUMATIC GROWTH INVENTORY; PSYCHOLOGIC TEST; PSYCHOTHERAPY; QUALITY OF LIFE; QUALITY OF LIFE ASSESSMENT; QUALITY OF LIFE AT THE END OF LIFE CANCER; RANDOMIZED CONTROLLED TRIAL; RATING SCALE; SHORT ORIENTATION MEMORY CONCENTRATION TEST; SINGLE BLIND PROCEDURE; SOLID TUMOR; SPIRITUALISM; TREATMENT DURATION; TREATMENT OUTCOME; ANXIETY; ATTITUDE TO DEATH; DEPRESSION; GERMANY; NEOPLASM; PALLIATIVE THERAPY; PATHOLOGY; PROCEDURES; PSYCHOLOGY; SHORT TERM PSYCHOTHERAPY;

ANXIETY; ATTITUDE TO DEATH; DEPRESSION; GERMANY; HUMANS; NEOPLASMS; PALLIATIVE CARE; PSYCHOTHERAPY, BRIEF; QUALITY OF LIFE; SINGLE-BLIND METHOD; TREATMENT OUTCOME;

EID: 84939523105     PISSN: None     EISSN: 14712407     Source Type: Journal    
DOI: 10.1186/s12885-015-1589-y     Document Type: Article

References (67)

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.
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.
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.
4. Neel C, Lo C, Rydall A, Hales S, Rodin G. Determinants of death anxiety in patients with advanced cancer. BMJ Support Palliat Care 2013. doi: 10.1136/bmjspcare-2012-000420 .
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.
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.
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. Miovic M, Block S. Psychiatric disorders in advanced cancer. Cancer. 2007;110:1665-76.
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.
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.
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.
14. Leung D, Esplen MJ. Alleviating existential distress of cancer patients: can relational ethics guide clinicians? Eur J Cancer Care. 2010;19:30-8.
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.
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.
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.
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.
22. Creamer M, Burgess P, Pattison P. Reaction to trauma: A cognitive processing model. J Abnorm Psychol. 1992;101:452-9.
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.
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.
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.
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.
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.
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.
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.
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.
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.
42. Spitzer RL, Kroenke K, Williams JBW, Löwe B. A brief measure for assessing Generalized Anxiety Disorder. Arch Intern Med. 2006;166:1092-7.
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.
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.
46. Kissane DW, Clarke DM, Street AF. Demoralization Syndrome - a relevant psychiatric diagnosis for palliative care. J Palliat Care. 2001;17:12-21.
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.
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.
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.
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.
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.
54. Tedeschi RG, Calhoun LG. The Posttraumatic Growth Inventory: measuring the positive legacy of trauma. J Trauma Stress. 1996;9:455-71.
55. Maercker A, Langner R. Persönliche Reifung (personal growth) durch Belastungen und Traumata: Validierung zweier deutschsprachiger Fragebogenversionen. Diagnostica. 2001;47:153-62.
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.
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.
59. Olso DH, Larson PJ, Olson-Sigg A. Couple Checkup: Tuning up relationships. J Couple Rel Therap. 2009;8:129-42.
60. PREPARE/ENRICH: building strong marriages [ https://www.prepare-enrich.com ]
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.
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.
64. Lachin JM. Introduction to sample size determination and power analysis for clinical trials. Control Clin Trials. 1981;2:93-113.
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.
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. Strengthening of palliative care as a component of integrated treatment within the continuum of care [ http://apps.who.int/gb/ebwha/pdf_files/EB134/B134_R7-en.pdf ]