Clinical trial NCT04324320: Psychological Distress in Outpatient Oncological Rehabilitation
Official title: Psychological Distress in Outpatient Oncological Rehabilitation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Distress
Oncology
Keywords: outpatient oncological rehabilitation
psychological distress
cross-sectional study
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2020-03-27
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: adult patients with all kinds of malignant tumour diseases and benign CNS tumours who present to the Outpatient Clinic for Oncological Rehabilitation at the Department of Physical Medicine, Rehabilitation and Occupational Medicine at the Medical University of Vienna

Brief summary: The aim of the study is to assess psychological distress and co-morbidity as well as relevant sociodemographic, anthropometric, medical and functional data in patients treated at the Outpatient Clinic for Oncological Rehabilitation at the Department of Physical Medicine, Rehabilitation and Occupational Medicine at the Medical University of Vienna.

Detailed description: Psychological distress in cancer patients is higher than in the average population and is associated with a lower health-related quality of life. In the course of the disease and its treatment, a psychological distress reaction can lead to a psychosocial crisis and a mental disorder that requires treatment. On average, 25% of all cancer patients suffer from depression, anxiety or adjustment disorders at any point in the course of their disease, and an average of 32% of all cancer patients express the need for psychosocial support. With an increasing reduction in inpatient length of stay times, outpatient care gains growing importance in the context of psycho-oncological diagnostics and aftercare. The overlap between physical symptoms due to cancer diagnosis and treatment and physical symptoms that are related to psychological burdens requires sensitive psycho-oncological diagnostics. This should be carried out as early as possible in the course of the disease so that existing psychological distress can be recognized early and thus a progression of the symptoms can be prevented.

The study aims to assess psychological distress and co-morbidity as well as relevant sociodemographic, anthropometric, medical and functional data in patients treated at the Outpatient Clinic for Oncological Rehabilitation at the Department of Physical Medicine, Rehabilitation and Occupational Medicine at the Medical University of Vienna.

Results should serve as a basis for further individual treatment recommendations.

By ascertaining the psychological distress, appropriate support and treatment measures can be recommended to the patients at an early stage, which help to improve the symptoms, enable participation and thus improve the quality of life of the patients. The assessment of the current individual need for psychological care also helps to refer patients to an inpatient oncological rehabilitation setting that provides the care that is needed more appropriately.

Results should also improve the psychological care of oncologic patients in general. Based on the findings, the psychological care offered within the framework of the current outpatient and inpatient oncological rehabilitation setting could be adapted and expanded as necessary. The results of the study should serve to integrate psycho-oncological care into the overall outpatient oncological rehabilitation concept.

A monocentric cross-sectional study is to be carried out on 165 patients with malignant tumour diseases as well as benign central nervous system tumours over a period of approximately 2 years.

Medical assessment of sociodemographic, anthropometric, medical and functional data will be performed. The gained information is also relevant for physical therapy prescription and treatment recommendations given by the physiatrist at the outpatient clinic for oncological rehabilitation.

Psychological distress and the need for psycho-oncological care for outpatients is determined through standardized screening and suitable assessment procedures. Patients will receive an immediate therapy recommendation regarding their psychological complaints by the clinical psychologist and psychotherapist who performs the assessment.

Eligibility criteria: Inclusion Criteria:

* patients with malignant tumour diseases and benign CNS tumours who present to the Outpatient Clinic for Oncological Rehabilitation at the Department of Physical Medicine, Rehabilitation and Occupational Medicine at the Medical University of Vienna
* patients who agree to participate in the study

Exclusion Criteria:

* bad physical condition that does not enable the patient to participate in the study
* language barriers (insufficient understanding of the German language)

Primary outcomes:
measure: anxiety, depression, stress: HADS-D
timeFrame: 5 minutes
Secondary outcomes:
measure: anthropometric data (weight, height, body mass index)
timeFrame: 3 minutes
measure: Psycho-oncologic basis assessment (PO-BADO)
timeFrame: 25-30 minutes
measure: Visual analog scale (VAS)
timeFrame: 2 minutes
measure: functional assessment: hand grip strength
timeFrame: 5 minutes
measure: functional assessment: 6 Minute Walking Test
timeFrame: 8 minutes
measure: functional assessment: Timed Get up and Go Test
timeFrame: 5 minutes
measure: Quality of life: Short- Form -36
timeFrame: 10 minutes
measure: subjective perceived stress: Perceived Stress Scale (PSS-10)
timeFrame: 5 minutes
measure: resilience: resilience scale (RS-13)
timeFrame: 5 minutes
measure: fatigue: brief fatigue inventory (BFI)
timeFrame: 5 minutes
measure: disability related to pain: Pain Disability Index (PDI)
timeFrame: 5 minutes
measure: workability: Work Ability Index - short version (WAI-K)
timeFrame: 5 minutes
measure: psychological assessment according to the diagnostic I.C.D.-10 based checklists
timeFrame: 90 minutes
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Richard Crevenna, Prof MD MBA MMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mehnert A, Koch U. Psychosocial care of cancer patients--international differences in definition, healthcare structures, and therapeutic approaches. Support Care Cancer. 2005 Aug;13(8):579-88. doi: 10.1007/s00520-005-0779-6. Epub 2005 Mar 1.
citation: Mehnert A, Lehmann C, Cao P, Koch U. [Assessment of psychosocial distress and resources in oncology--a literature review about screening measures and current developments]. Psychother Psychosom Med Psychol. 2006 Dec;56(12):462-79. doi: 10.1055/s-2006-951828. German.
citation: Fallowfield L, Ratcliffe D, Jenkins V, Saul J. Psychiatric morbidity and its recognition by doctors in patients with cancer. Br J Cancer. 2001 Apr 20;84(8):1011-5. doi: 10.1054/bjoc.2001.1724.
citation: Herschbach P, Book K, Brandl T, Keller M, Lindena G, Neuwohner K, Marten-Mittag B. Psychological distress in cancer patients assessed with an expert rating scale. Br J Cancer. 2008 Jul 8;99(1):37-43. doi: 10.1038/sj.bjc.6604420. Epub 2008 Jun 24.
citation: Herschbach P, Keller M, Knight L, Brandl T, Huber B, Henrich G, Marten-Mittag B. Psychological problems of cancer patients: a cancer distress screening with a cancer-specific questionnaire. Br J Cancer. 2004 Aug 2;91(3):504-11. doi: 10.1038/sj.bjc.6601986.
citation: Harkonen R, Harju R, Alaranta H. Accuracy of the Jamar dynamometer. J Hand Ther. 1993 Oct-Dec;6(4):259-62. doi: 10.1016/s0894-1130(12)80326-7.
citation: Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.
citation: Casanova C, Celli BR, Barria P, Casas A, Cote C, de Torres JP, Jardim J, Lopez MV, Marin JM, Montes de Oca M, Pinto-Plata V, Aguirre-Jaime A; Six Minute Walk Distance Project (ALAT). The 6-min walk distance in healthy subjects: reference standards from seven countries. Eur Respir J. 2011 Jan;37(1):150-6. doi: 10.1183/09031936.00194909. Epub 2010 Jun 4.
citation: Manttari A, Suni J, Sievanen H, Husu P, Vaha-Ypya H, Valkeinen H, Tokola K, Vasankari T. Six-minute walk test: a tool for predicting maximal aerobic power (VO2 max) in healthy adults. Clin Physiol Funct Imaging. 2018 May 31. doi: 10.1111/cpf.12525. Online ahead of print.
citation: Schmidt K, Vogt L, Thiel C, Jager E, Banzer W. Validity of the six-minute walk test in cancer patients. Int J Sports Med. 2013 Jul;34(7):631-6. doi: 10.1055/s-0032-1323746. Epub 2013 Feb 26.
citation: Klein EM, Brahler E, Dreier M, Reinecke L, Muller KW, Schmutzer G, Wolfling K, Beutel ME. The German version of the Perceived Stress Scale - psychometric characteristics in a representative German community sample. BMC Psychiatry. 2016 May 23;16:159. doi: 10.1186/s12888-016-0875-9.
citation: 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 Manage. 2003 May;25(5):449-58. doi: 10.1016/s0885-3924(03)00073-3.
citation: van den Berg TI, Elders LA, de Zwart BC, Burdorf A. The effects of work-related and individual factors on the Work Ability Index: a systematic review. Occup Environ Med. 2009 Apr;66(4):211-20. doi: 10.1136/oem.2008.039883. Epub 2008 Nov 18.