Psychological Distress in Outpatient Oncological Rehabilitation

Oncology Clinical Trial

Official title:

Psychological Distress in Outpatient Oncological Rehabilitation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04324320
• Other study ID #: 1162/2020
• Status: Not yet recruiting
• Start date: September 2020
• Est. completion date: December 2022

Study information

• Verified date: March 2020
• Source: Medical University of Vienna
• Contact: Barbara Wagner, MD
• Phone: +43-1-40400-43300
• Email: barbara.wagner[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Observational

Clinical 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 Medical University of Vienna.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 165
• Est. completion date: December 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Distress
• Neoplasms
• Oncology

Intervention

Diagnostic Test:
• 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))

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

References & Publications (13)

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. — View 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. — View Citation

Härkönen R, Harju R, Alaranta H. Accuracy of the Jamar dynamometer. J Hand Ther. 1993 Oct-Dec;6(4):259-62. — View Citation

Herschbach P, Book K, Brandl T, Keller M, Lindena G, Neuwöhner 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. — View 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. — View Citation

Klein EM, Brähler E, Dreier M, Reinecke L, Müller KW, Schmutzer G, Wölfling 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. — View Citation

Mänttäri A, Suni J, Sievänen H, Husu P, Vähä-Ypyä H, Valkeinen H, Tokola K, Vasankari T. Six-minute walk test: a tool for predicting maximal aerobic power (VO(2 ) max) in healthy adults. Clin Physiol Funct Imaging. 2018 May 31. doi: 10.1111/cpf.12525. [Epub ahead of print] — View 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. Epub 2005 Mar 1. — View 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. Review. German. — View 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. — View 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. — View Citation

Schmidt K, Vogt L, Thiel C, Jäger 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. — View 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. Review. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	anthropometric data (weight, height, body mass index)	weight, height and body mass index are measured	3 minutes
Secondary	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.	25-30 minutes
Secondary	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.	2 minutes
Secondary	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.	5 minutes
Secondary	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.	8 minutes
Secondary	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.	5 minutes
Secondary	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.	10 minutes
Secondary	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".	5 minutes
Secondary	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.	5 minutes
Secondary	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.	5 minutes
Secondary	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.)	5 minutes
Secondary	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.	5 minutes
Secondary	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).	90 minutes