Psychological Distress in Outpatient Oncological Rehabilitation
NCT ID: NCT04324320
Last Updated: 2020-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
165 participants
OBSERVATIONAL
2020-09-30
2022-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Disease Course in Oncological Patients During Inpatient Rehabilitation and After Three Months Follow-up
NCT04842214
Indication-based Identification and Psychosocial Treatment of Orthopedic Cancer Patients
NCT01631175
Optimized Rehabilitation Following Primary Breast Cancer Surgery
NCT03434717
Existential Distress in Patients with Advanced Cancer and Their Caregivers
NCT04600206
Early Rehabilitation of Cancer Patients
NCT01588262
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
outpatients (oncological rehabilitation)
the population studied in this cross-sectional study includes patients with malignant tumour diseases and benign CNS tumours who present to the Outpatient Clinic for Oncological Rehabilitation at the Department of Physical Medicine and Rehabilitation of the Medical University of Vienna
medical assessment
medical assessment includes the collection of
* sociodemographic data
* anthropometric data (weight, height, body mass index)
* medical data
* psycho-oncologic basis assessment (PO-BADO questionnaire)
* pain assessment (VAS: visual analogue scale)
* 3 functional tests:
* handgrip strength
* 6 Minute Walking Test
* Timed Get up and Go Test
psychological assessment
psychological assessment includes several standardized screening and assessment questionnaires and tools:
* quality of life: SF-36
* anxiety, depression, stress: Hospital Anxiety and Depression Scale (HADS-D)
* subjective stress perception: Perceived Stress Scale (PSS-10)
* resilience: resilience scale (RS-13)
* fatigue: Brief Fatigue Inventory (BFI)
* disability related to pain: Pain Disability Index (PDI)
* workability: Work Ability Index - short version (WAI-K)
* psychological assessment based on the checklist of the International Diagnoses (IDCL) for ICD-10 and the ICD-10 checklist of symptoms for psychological disorders (SCL))
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
medical assessment
medical assessment includes the collection of
* sociodemographic data
* anthropometric data (weight, height, body mass index)
* medical data
* psycho-oncologic basis assessment (PO-BADO questionnaire)
* pain assessment (VAS: visual analogue scale)
* 3 functional tests:
* handgrip strength
* 6 Minute Walking Test
* Timed Get up and Go Test
psychological assessment
psychological assessment includes several standardized screening and assessment questionnaires and tools:
* quality of life: SF-36
* anxiety, depression, stress: Hospital Anxiety and Depression Scale (HADS-D)
* subjective stress perception: Perceived Stress Scale (PSS-10)
* resilience: resilience scale (RS-13)
* fatigue: Brief Fatigue Inventory (BFI)
* disability related to pain: Pain Disability Index (PDI)
* workability: Work Ability Index - short version (WAI-K)
* psychological assessment based on the checklist of the International Diagnoses (IDCL) for ICD-10 and the ICD-10 checklist of symptoms for psychological disorders (SCL))
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* patients who agree to participate in the study
Exclusion Criteria
* language barriers (insufficient understanding of the German language)
18 Years
100 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medical University of Vienna
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Richard Crevenna
Univ. Prof. Dr., MBA, MMSc, Head of the Department of Physical Medicine, Rehabilitation and Occupational Medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Richard Crevenna, Prof MD MBA MMSc
Role: PRINCIPAL_INVESTIGATOR
Medical University of Vienna
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medical University of Vienna
Vienna, , Austria
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Barbara Wagner, MD
Role: primary
Margarete Steiner, MSc
Role: backup
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1162/2020
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.