NCT04324320

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
165

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 27, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

March 27, 2020

Status Verified

March 1, 2020

Enrollment Period

1.2 years

First QC Date

March 25, 2020

Last Update Submit

March 25, 2020

Conditions

DistressOncology

Keywords

outpatient oncological rehabilitationpsychological distresscross-sectional study

Outcome Measures

Primary Outcomes (1)

  • anxiety, depression, stress: HADS-D

    HADS-D is a validated screening tool (questionnaire) to assess anxiety and depression in patients with physical and psychological disorders, especially taking into account a physical primary disease.

    5 minutes

Secondary Outcomes (13)

  • anthropometric data (weight, height, body mass index)

    3 minutes

  • Psycho-oncologic basis assessment (PO-BADO)

    25-30 minutes

  • Visual analog scale (VAS)

    2 minutes

  • functional assessment: hand grip strength

    5 minutes

  • functional assessment: 6 Minute Walking Test

    8 minutes

  • +8 more secondary outcomes

Study Arms (1)

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

Diagnostic Test: medical assessmentDiagnostic Test: psychological assessment

Interventions

medical assessmentDIAGNOSTIC_TEST

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

outpatients (oncological rehabilitation)
psychological assessmentDIAGNOSTIC_TEST

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))

outpatients (oncological rehabilitation)

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (13)

  • 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.

    PMID: 15739056BACKGROUND

  • 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.

    PMID: 17160791BACKGROUND

  • 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.

    PMID: 11308246BACKGROUND

  • 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.

    PMID: 18577997BACKGROUND

  • 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.

    PMID: 15238979BACKGROUND

  • 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.

    PMID: 8124439BACKGROUND

  • 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.

    PMID: 1991946BACKGROUND

  • 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.

    PMID: 20525717BACKGROUND

  • 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.

    PMID: 29851229BACKGROUND

  • 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.

    PMID: 23444095BACKGROUND

  • 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.

    PMID: 27216151BACKGROUND

  • 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.

    PMID: 12727043BACKGROUND

  • 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.

    PMID: 19017690BACKGROUND

MeSH Terms

Conditions

Neoplasms

Interventions

Physical Examination

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Richard Crevenna, Prof MD MBA MMSc

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbara Wagner, MD

CONTACT

+43-1-40400-43300barbara.wagner@meduniwien.ac.at

Margarete Steiner, MSc

CONTACT

+43-1-40400-43300margarete.steiner@meduniwien.ac.at

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Univ. Prof. Dr., MBA, MMSc, Head of the Department of Physical Medicine, Rehabilitation and Occupational Medicine

Study Record Dates

First Submitted

March 25, 2020

First Posted

March 27, 2020

Study Start

September 1, 2020

Primary Completion

December 1, 2021

Study Completion

December 1, 2022

Last Updated

March 27, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)