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Psychological Distress in Outpatient Oncological Rehabilitation

2020年3月25日 更新者:Richard Crevenna、Medical University of Vienna
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.

研究概览

详细说明

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.

研究类型

观察性的

注册 (预期的)

165

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Vienna、奥地利、1090
        • Medical University of Vienna

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 100年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

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

描述

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)

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:其他
  • 时间观点:横截面

队列和干预

团体/队列
干预/治疗
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 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 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))

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
anxiety, depression, stress: HADS-D
大体时间: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.
5 minutes

次要结果测量

结果测量
措施说明
大体时间
anthropometric data (weight, height, body mass index)
大体时间:3 minutes
weight, height and body mass index are measured
3 minutes
Psycho-oncologic basis assessment (PO-BADO)
大体时间:25-30 minutes
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
Visual analog scale (VAS)
大体时间:2 minutes
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
functional assessment: hand grip strength
大体时间:5 minutes
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
functional assessment: 6 Minute Walking Test
大体时间:8 minutes
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
functional assessment: Timed Get up and Go Test
大体时间:5 minutes
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
Quality of life: Short- Form -36
大体时间:10 minutes
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
subjective perceived stress: Perceived Stress Scale (PSS-10)
大体时间:5 minutes
The PSS-10 scale measures the subjective perception of stress. 2 scales evaluate the domains "helplessness" and "self-efficacy".
5 minutes
resilience: resilience scale (RS-13)
大体时间:5 minutes
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
fatigue: brief fatigue inventory (BFI)
大体时间:5 minutes
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
disability related to pain: Pain Disability Index (PDI)
大体时间:5 minutes
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
workability: Work Ability Index - short version (WAI-K)
大体时间:5 minutes
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
psychological assessment according to the diagnostic I.C.D.-10 based checklists
大体时间:90 minutes
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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Richard Crevenna, Prof MD MBA MMSc、Medical University of Vienna

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (预期的)

2020年9月1日

初级完成 (预期的)

2021年12月1日

研究完成 (预期的)

2022年12月1日

研究注册日期

首次提交

2020年3月25日

首先提交符合 QC 标准的

2020年3月25日

首次发布 (实际的)

2020年3月27日

研究记录更新

最后更新发布 (实际的)

2020年3月27日

上次提交的符合 QC 标准的更新

2020年3月25日

最后验证

2020年3月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 1162/2020

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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