DistressNCT04324320
Psychological Distress in Outpatient Oncological Rehabilitation
An observational study of Distress and Oncology, run by Medical University of Vienna at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- What is being tested?
- medical assessment and psychological assessment
- How many people
- 165 participants
- Where
- 1 siteAustria
- Study dates
- Sep 2020to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- bad physical condition that does not enable the patient to participate in the study
- language barriers (insufficient understanding of the German language)
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Vienna
Vienna, 1090
Barbara Wagner, MD, +43 1 40400 43300
Margarete Steiner, MSc, +43 1 40400 43300
About this study
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.
Read the 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.
- Being tested
- medical assessment, psychological assessment
- Keywords
- outpatient oncological rehabilitation, psychological distress, cross-sectional study
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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))
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: medical assessment; Diagnostic Test: psychological assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 minutes
Secondary outcomes (13)
anthropometric data (weight, height, body mass index)
weight, height and body mass index are measured
Measured: 3 minutes
Psycho-oncologic basis assessment (PO-BADO)
The PO-BADO is a rating scale to assess the subjectively perceived stress in oncologic patients. The assessment is performed by a physician. Sociodemographic and medical data as well as psychologic distress are evaluated. Further relevant sociodemographic and medical data is assessed by a physician.
Measured: 25-30 minutes
Visual analog scale (VAS)
The visual analog scale is a semiquantitative test to assess subjective pain intensity on a scale between 0-10 (0 being no pain at all, 10 being the worst pain imaginable). The patient is asked to report the most intense pain within the last week that is associated with the cancer diagnosis/treatment as well as musculoskeletal pain.
Measured: 2 minutes
functional assessment: hand grip strength
Hand grip strength measures the maximal isometric handgrip strength using a JAMAR®dynamometer (in kilograms). Assessment is performed in a standardized position, sitting on a chair, elbow is flexed 90 degrees, upper extremity is in neutral position. 3 assessments are performed with the dominant hand, the mean value is registered. The motoric skill strength is assessed.
Measured: 5 minutes
functional assessment: 6 Minute Walking Test
The 6 Minute Walking Test (6MWT) is used to estimate the basic motoric function endurance. It helps to evaluate the patients cardiovascular and pulmonal performance below the anerobic threshold. The patient is asked to quickly walk (not run) for 6 minutes, the distance walked within 6 minutes is measured. Walking aids and taking a break if needed is allowed. This test has been validated and recommended for cancer patients.
Measured: 8 minutes
functional assessment: Timed Get up and Go Test
Timed Get up and Go Test (TGU): this standardized test assesses functional mobility. The patient is asked to sit on a chair with armrests. When told, he has to get up without the help of other persons, walk a distance of 3 meters, turn and sit down again. Walking aids such as a cane are allowed to use if necessary. The time is registered that the person needs for that maneuver (< 10 seconds indicate no limitations in mobility). The test has a good validity and reliability.
Measured: 5 minutes
Quality of life: Short- Form -36
The Short Form -36 is a validated questionnaire to assess the health-related quality of life. There are 8 dimensions of the test that can be summarized into the main domains "physical health" and "mental health". Also, changes compared to the year before are evaluated.
Measured: 10 minutes
subjective perceived stress: Perceived Stress Scale (PSS-10)
The PSS-10 scale measures the subjective perception of stress. 2 scales evaluate the domains "helplessness" and "self-efficacy".
Measured: 5 minutes
resilience: resilience scale (RS-13)
Resilience is seen as a criterion of emotional stability and psychological health. It is a personal resource to deal with stressful events in life. This one-dimensional scale evaluates the resilience of a person.
Measured: 5 minutes
fatigue: brief fatigue inventory (BFI)
The BFI score is a validated tool to assess cancer-related fatigue. The questionnaire consists of 10 items that capture 6 dimensions: activity, mood, mobility, work, social relation and vitality.
Measured: 5 minutes
disability related to pain: Pain Disability Index (PDI)
The PDI is used to assess the subjective impairment of a chronic pain situation in everyday life. The questionnaire is based on a multidimensional concept of impairment due to the pain condition. It differentiates between damage, disability and discrimination. It evaluates 7 areas of life (family/home, recreation, social activities, work, sexuality, self-supply, vital activities.)
Measured: 5 minutes
workability: Work Ability Index - short version (WAI-K)
The WAI evaluates the amount to which employed people are able to do their work in light of health, mental resources and work requirements. It helps to estimate the individual performance regarding the current working situation. It consists of 10 items and 7 dimensions. The summary score is a measure for the subjective estimate of the own capacity to meet work requirements.
Measured: 5 minutes
psychological assessment according to the diagnostic I.C.D.-10 based checklists
The psychological assessment is based on the results of the screening tools to identify psychosocial stress/ disorders. It aims to further evaluate the present problems and clarify whether symptoms are subsyndromal or fulfil the criteria of a mental disorder according to the I.C.D.-10 classification. External assessment tools used are the international diagnostic checklist for I.C.D.-10 (IDCL) and the I.C.D.-10 symptom checklist for mental disorders (SCL).
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study startSep 2020 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for DistressStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Crevenna, Medical University of Vienna
- Investigators
- Richard Crevenna, Prof MD MBA MMSc, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04324320
- Sponsor's protocol ID
- 1162/2020
- Status last verified
- Mar 2020
- First submitted
- 25 Mar 2020
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15739056Mehnert 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.
PubMed 17160791Fallowfield 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.
PubMed 11308246Herschbach 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.
PubMed 18577997Herschbach 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.
PubMed 15238979Harkonen 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.
PubMed 8124439Podsiadlo 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.
PubMed 1991946Casanova 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.
PubMed 20525717Manttari 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.
PubMed 29851229Schmidt 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.
PubMed 23444095Klein 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.
PubMed 27216151Radbruch 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.
PubMed 12727043van 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.
PubMed 19017690
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Distress in Outpatient Oncological Rehabilitation
- ClinicalTrials.gov ID
- NCT04324320
- Acronym / sponsor ID
- 1162/2020
- Keywords
- outpatient oncological rehabilitation, psychological distress, cross-sectional study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Sep 2020 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 27 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| outpatients (oncological rehabilitation) | – | Diagnostic Test: medical assessment, Diagnostic Test: psychological assessmentthe 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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- bad physical condition that does not enable the patient to participate in the study
- language barriers (insufficient understanding of the German language)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| medical assessmentmedical 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 | Diagnostic test | outpatients (oncological rehabilitation) |
| psychological assessmentpsychological 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)) | Diagnostic test | outpatients (oncological rehabilitation) |
Primary outcome
anxiety, depression, stress: HADS-D
Time frame: 5 minutes
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.
13 secondary outcomes
anthropometric data (weight, height, body mass index)
Time frame: 3 minutes
Psycho-oncologic basis assessment (PO-BADO)
Time frame: 25-30 minutes
Visual analog scale (VAS)
Time frame: 2 minutes
functional assessment: hand grip strength
Time frame: 5 minutes
functional assessment: 6 Minute Walking Test
Time frame: 8 minutes
functional assessment: Timed Get up and Go Test
Time frame: 5 minutes
Quality of life: Short- Form -36
Time frame: 10 minutes
subjective perceived stress: Perceived Stress Scale (PSS-10)
Time frame: 5 minutes
resilience: resilience scale (RS-13)
Time frame: 5 minutes
fatigue: brief fatigue inventory (BFI)
Time frame: 5 minutes
disability related to pain: Pain Disability Index (PDI)
Time frame: 5 minutes
workability: Work Ability Index - short version (WAI-K)
Time frame: 5 minutes
psychological assessment according to the diagnostic I.C.D.-10 based checklists
Time frame: 90 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2020.
- Background: PubMed 15739056Mehnert 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.
- Background: PubMed 17160791Mehnert 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.
- Background: PubMed 11308246Fallowfield 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.
- Background: PubMed 18577997Herschbach 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.
- Background: PubMed 15238979Herschbach 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.
- Background: PubMed 8124439Harkonen 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.
- Background: PubMed 1991946Podsiadlo 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.
- Background: PubMed 20525717Casanova 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.
- Background: PubMed 29851229Manttari 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.
- Background: PubMed 23444095Schmidt 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.
- Background: PubMed 27216151Klein 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.
- Background: PubMed 12727043Radbruch 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Crevenna, Prof MD MBA MMSc principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Distress and Oncology, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barbara Wagner, MD (+43-1-40400-43300, barbara.wagner@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anxiety, depression, stress: HADS-D (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04324320, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2020.