Trial document





This trial has been registered retrospectively.
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  DRKS00000312

Trial Description

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Title

Symptom trajectories in patients with advanced chronic obstructive pulmonary disease (COPD) or lung cancer - a prospective longitudinal study

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Trial Acronym

SYMPATIE study

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URL of the Trial

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Brief Summary in Lay Language

Most patients, particularly with an advanced disease and near the end of life, want to stay at home until they die on condition of good health care service provision and availability. But again and again, crises of different origin hinder patients in their wish, especially in the more advanced stages of disease. Currently, it is unknown which crises are common in patients; which are the most important; how patients cope with these critical incidents; which early warning signs possibly exist (indicators for prevention of crises), and how patients and their informal caregivers experience different health care service provisions in times of crises.
Aim. The aim of this study is to describe and analyse experiences of crises and crises management in patients with advanced COPD or lung cancer and their informal caregivers. On basis of this knowledge, appropriate and effective strategies and health care services will be developed for the prevention and management of these crises in order to stabilise and enhance patients’ and carers’ quality of life. In order to assess occurrence of and experiences with crises over a longer period of time, 100 patients will be interviewed several times within a year about their symptoms, other problems, use of medical emergency services (i.e. hospital emergency department), and number and nature of crises using telephone interviews.

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Brief Summary in Scientific Language

Background: Breathlessness is a complex and common symptom in patients with lung cancer or advanced chronic obstructive pulmonary disease (COPD), particularly in the last year of life. Patients with lung cancer experience the highest physical and psychosocial symptom burden compared to all cancer patients. Beside breathlessness, patients in both disease groups suffer from a high number of other symptoms such as fatigue, cough, anxiety, weakness etc. In a number of prevalence studies, the symptom burden was well described. However, little is known about breathlessness trajectories and trajectories of other burdensome symptoms in both patient groups. But this information is crucial for the development of effective strategies to alleviate symptom burden and enhance quality of life. For instance, information about timing of symptoms and at which time symptoms are prevalent to a certain degree can inform service development and indicate when service provision is appropriate. For this reason, breathlessness and other symptoms as well as functional ability, quality of life and palliative care needs will be investigated in patients with COPD or lung cancer over a period of 12 months. Moreover, trajectories of these symptoms will be analysed.
Aim: The aim of the study is to describe trajectories of breathlessness and other symptoms in patients with lung cancer or advanced COPD at the end of life.
Methods: A prospective, multi-center, longitudinal study over a period of 12 months will be undertaken. 50 patients with lung cancer or advanced COPD (COLD stages III & IV), respectively, will be personally interviewed in detail at baseline and then once a month using telephone interviews (follow-up). Validated questionnaires for assessment of the following variables will be used: severity of breathlessness (modified Borg scale) and characteristics of episodes of breathlessness; other symptoms and needs (POS; Palliative Outcome Scale); functional ability (Karnofsky Performance Status); distress (Distress Thermometer); utilization of emergency services (hospital admissions, A&E department visits); prevalence of crises (patient-defined). In addition, demographic and clinical data will be assessed. Data will be analysed using the statistical software package STATA. Data collection will take place from February, 2010 till February, 2011.

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Organizational Data

  •   DRKS00000312
  •   2010/07/15
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  •   yes
  •   Approved
  •   Bo/20/2009, Ethikkommission bei der Ärztekammer Niedersachsen
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Secondary IDs

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Health Condition or Problem studied

  •   J44 -  Other chronic obstructive pulmonary disease
  •   C34 -  Malignant neoplasm of bronchus and lung
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Interventions/Observational Groups

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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Other
  •   Open (masking not used)
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  •   Other
  •   Other
  •   Other
  •   N/A
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Primary Outcome

Dyspnoea: modified Borg-Scale; episodic breathlessness: number of attacks, mean length of attack, severity of attack
Time of measurement: every 4 weeks

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Secondary Outcome

symptoms and needs: Palliative Care Outcome Scale (POS); functional ability: Karnofsky Performance Scale (KPS); quality of life: EuroQoL5 (EQ-5D); health service use: number of hospital admissions, number of admissions to A&E; comorbidities: Charlson Comorbidity Index (CCI)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2010/02/10
  •   100
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Patients with the following criteria will be eligible for this study.
The inclusion criteria will be:
1)diagnosis of advanced disease as defined as follows:
Lung cancer: Primary lung cancer at all stages (small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC)), cancer at any site with secondary tumour of the lung (lung metastasis);
COPD: stage III or IV of the GOLD classification (Global Initiative for Obstructive Lung Disease), which include the airflow limitation measured by spirometry FEV1 < 50%, FEV1/FVC < 0.7 (FEV1: forced expiratory volume in one second; FVC: forced vital capacity) and symptoms such as more severe breathlessness, reduced exercise capacity and repeated exacerbations;
2)age ≥ 18 years.
Disease orientated therapies (chemotherapy, radiotherapy, surgery) can be ongoing.

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Exclusion Criteria

(1) lack of capacity to give informant consent; (2) lack of capacity to be interviewed;(3)cognitive impairment (clinical judgment by the principal investigator)

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Addresses

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    • Institut für Palliative Care (ipac) e.V.
    • Mr.  Dr.  Steffen  Simon 
    • Jägerstraße 64-66
    • 26121  Oldenburg
    • Germany
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    • Institut für Palliative Care (ipac) e.V.
    • Mr.  Dr.  Steffen  Simon 
    • Jägerstraße 64-66
    • 26121  Oldenburg
    • Germany
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    • Institut für Palliative Care (ipac) e.V.
    • Mr.  Dr.  Steffen  Simon 
    • Jägerstraße 64-66
    • 26121  Oldenburg
    • Germany
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Sources of Monetary or Material Support

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    • VDI/VDE/IT GmBH (Vertreter des BMBF)
    • Ms.  Dagmar  Stobernack 
    • Steinplatz 1
    • 10623  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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