Trial document





This trial has been registered retrospectively.
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  DRKS00000476

Trial Description

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Title

Experiences of crises in patients with advanced chronic obstructive pulmonary disease (COPD) or lung cancer and their carers - a qualitative interview study

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Trial Acronym

[---]*

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URL of the Trial

http://www.ipac.org www.paaliativ.de

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Brief Summary in Lay Language

Background: 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 ones; 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 crisis 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. To assess experiences with crises, 80 patients and their informal caregivers will be personally interviewed. Interviews will be analysed using a scientific approach.

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Brief Summary in Scientific Language

Background: Critical incidents are common in patients with advanced, life-limiting diseases, particularly in their last year of life. These crises contribute significantly to the burden of patients, but also to the burden of informal caregivers and professional carers. A crisis can be preliminary defined as the (sudden) occurrence and escalation of a problematic situation. In their last year of life, most people want to stay at home until they die on condition of good and qualified health service provisions. But often critical incidents result in repeated hospital admissions and hinder patients in their wish to stay at home. Currently, information necessary for the development of effective strategies for prevention and management of crises is lacking. For instance, it is unknown which crises are most prevalent, how they develop (trajectories) and what patients’ and carers’ needs for support are. In Germany lung cancer is the most common cause of death within the group of malignant diseases. In the group of non-malignant diseases, chronic obstructive pulmonary disease (COPD) is the second leading cause of death, but its prevalence is rising. Patients with lung cancer or advanced COPD, as an example for malignant and non-malignant diseases respectively, and their informal caregivers will be included in this study.
Aim: The aim of this study is to describe and analyse experiences of crises in patients with COPD or lung cancer in order to develop appropriate and effective strategies for prevention and management of crises.
Methods: A qualitative-descriptive design is used. Personal, open (face-to-face) and in depth interviews will be performed, recorded, transcribed verbatim and content-analysed using the NVivo software package. 20 patients with COPD (GOLD stages III & IV) or lung cancer, as well as 20 informal caregivers in each group will be included in the study (overall n = 80). Data collection will take place from February, 2010 till February, 2011.

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Organizational Data

  •   DRKS00000476
  •   2010/08/18
  •   [---]*
  •   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
  •   Other
  •   Other
  •   Open (masking not used)
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  •   Other
  •   Other
  •   Other
  •   N/A
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Primary Outcome

Description of experiences of crises in patients with advanced chronic obstructive pulmonary disease or lung cancer and their caregivers

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Secondary Outcome

Demographic data (age, gender, nationality, marital status, children, caregivers, education, smoking status, technical equipment (e.g. internet use)); disease data (disease, stage, comorbidities, lung function and Hb, disease-specific therapies, other therapies (i.e. pain medication), function by Karnofsky Performance Status, number of hospital admissions in the last 12 months)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2010/02/10
  •   80
  •   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));
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.
Carers are people who are close related to the patient and chosen by the patient.

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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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    • BMBF (in charge: VDI/VDE/IT GmBH)
    • 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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* This entry means the parameter is not applicable or has not been set.