Clinical trial NCT00792974: End-of-Life Fear in Patients With End-Stage Lung Disease (COPD)
Official title: End-of-Life Fear in Patients With End-Stage Lung Disease: Fears of Death and Dying, Wishes and Needs of Patients With Severe COPD
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Obstructive Pulmonary Disease
End-of-Life Fear
Fear About Death and Dying
Depression
Keywords: Cognitive behavioral education
COPD (Chronic Obstructive Pulmonary Disease), GOLD II-IV
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2008-11-18
Enrollment: 199
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects are recruited from the Pulmonary Rehabilitation Units of the Berchtesgadener Klinikum Schönau, Germany, through direct recruitment and use auf administrative databases. All patients who are alert and can provide consent are invited to participate, if they have a chronic obstructive pulmonary disease with stage II, III or IV by GOLD-criteria. An open three group comparison is made of one-hundred patients with severe COPD (stage III and IV), thirty-three patients with moderate COPD (stage II), thirty-three patients with hip prosthesis and thirty-three mental healthy persons in match-able age.

Brief summary: The aim of the study is to develop an interview to ask patients with COPD about their fear of death and dying, their needs and wishes at the end-of-life. Afterwards, the patients receive a brief psychological intervention to develop coping strategies for chronic illness. Beside this a general purpose of this intervention is to improve patients' quality of life.

Detailed description: Background:

COPD-related mortality differs markedly from that of other chronic diseases. While the mortality rates for heart disease and stroke have fallen significantly, death rates caused by COPD have more than doubled. Therefore there is a major need to address questions of palliative end-of-life care. Patients with end-stage pulmonary lung diseases suffer from dyspnea, severe pain, fatigue and - the "deadlock" in end-of-life communication. Many people with severe COPD are socially isolated, have low quality of life and psychosocial challenges such as sadness, panic or hopelessness. In fact, 70 up to 90% suffer from a clinically relevant depression and/or anxiety disorder. Despite this, the majority of COPD patients with co-morbid disorders don't receive any treatment for their psychological symptoms. Furthermore, there is substantial evidence that only a minority of people with end-stage COPD have the opportunity to discuss their fears and wishes for end-of-life care. The few existing studies on this issue demonstrated that the majority of people with severe COPD wants to discuss topics such as prognosis, fear of death and dying or preferences and needs at the end-of-life. Understanding the nature and implications of treatment options is an important component of advanced care planning for people with end-stage lung disease.

Therefore the aim of this study is to bring up the end-of-life communication to patients with end-stage COPD. We hypothesize that end-stage COPD patients have greater fear of death and dying as patients with mild to moderate COPD or with hip prothesis (control group). The lowest anxiety rate with regard to death should be found in the healthy control group. Furthermore, a brief psychological intervention should decrease the co-morbid psychological symptoms and patients' fears. Higher quality of life should be achieved.

Objectives:

Subjects are recruited from the Pulmonary Rehabilitation Units of the Berchtesgadener Klinikum Schönau, Germany, through direct recruitment and use of administrative databases. All patients providing informed consent are invited to participate, if they have a chronic obstructive pulmonary disease with stage II, III or IV by GOLD-criteria. An open three group comparison is made of one-hundred patients with severe COPD (stage III and IV), thirty-three patients with moderate COPD (stage II), thirty-three patients with hip prosthesis and thirty-three mental healthy persons matched for age and sex. As we want to start a first feasibility intervention study, this is a clinical controlled design without randomization.

Methods:

Initially a systematic literature review was performed to determine what methods are being used in COPD studies and how the patients' views can be best assessed. Then a qualitative multi-method design will be used involving semi-structured interviews, standardized questionnaires and lung function parameters.

The face-to-face interview includes ten categories with more than 70 questions on

1. social demography
2. actual health status
3. knowledge and wishes of further information about the disease
4. thoughts and attitudes about the illness
5. fears about the illness, treatment and prognosis
6. general experiences of death and dying
7. own experiences with death and dying
8. fear of death
9. fear of dying
10. end-of-life decisions such as wishes and needs

Patients will be interviewed by a single interviewer. Each question will be read by using everyday language. Interviews will be audiotaped to control for integrity. Each interview will last approximately 60 minutes. The interview will be validated by the COPD-Anxiety-Questionnaire (CAF). To assess the patients cognitions about death, a self-report questionnaire, FIMEST, will be also used.

Standardized questionnaires will be used to detect depression or panic disorders by the Hospital Anxiety and Depression Scale. Functional health status will be measured by the Patients Health Questionnaire (PHQ) and the COPD-Disability- Index (CDI). The condition specific questionnaire, the Short Form-36 Health Survey (SF-36) and Euroqol (EQ) will be compared for their discriminative and evaluative properties. Spirometric tests and a walking test will be also performed.

After the interview those patients who have increased death anxiety take part in a brief psychological intervention to discuss their end-of-life issues, worries and fears. For this psychological intervention, a manualized 2-3-session approach will be used.

Eligibility criteria: Inclusion Criteria:

* 50 years or older
* COPD diagnosis III and IV by GOLD-criteria with or without an indication for long-term oxygen therapy (LTOT), non invasive ventilation (NIV) and/or lung transplantation (LTx)
* COPD diagnosis II by GOLD-criteria
* Patients with hip prosthesis
* Mental healthy people, who have no severe illness (such as heart disease or cancer) one year before

Exclusion Criteria:

* Participation in other studies likely to influence the patient in terms of confounding effects
* Acute and severe exacerbations with hard symptoms over 4 days
* Patients need a increasing medication of steroids and/or antibiotics
* Non-compliance

Primary outcomes:
measure: Self-reported semi-structured interview about the fear of death and dying, needs and wishes at the end-of-life in patients with severe COPD
timeFrame: Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment
Secondary outcomes:
measure: St. George's Respiratory Questionnaire (SGRQ)
timeFrame: Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment
measure: Short Form Health Survey (Fragebogen zum allgemeinen Gesundheitszustand, SF-36)
timeFrame: Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment
measure: Euroqol (EQ)
timeFrame: Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment
measure: Patient Health Questionnaire (PHQ)
timeFrame: Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment
measure: Borg Scale
timeFrame: Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment
measure: Diffusion capacity (DLCO)
timeFrame: Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment
measure: Blood gas analysis (BGA)
timeFrame: Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment
measure: Bodyplethysmographs
timeFrame: Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment
measure: Bio-Impedance-Analysis (BIA)
timeFrame: Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment
measure: 6-Minute Walk Distance (6 MWD)
timeFrame: Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment
measure: Body Mass Index (BMI)
timeFrame: Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment
measure: Blood tests
timeFrame: Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment
measure: Multidimensional assessment of attitudes toward death and dying (Fragebogeninventar zur mehrdimensionalen Erfassung des Erlebens gegenüber Sterben und Tod, FIMEST)
timeFrame: Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment
measure: COPD- Anxiety -Questionnaire (COPD-Angst-Fragebogen, CAF)
timeFrame: Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment
measure: COPD- Disability- Index (CDI)
timeFrame: Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment
measure: Differences in COPD admission rates, functional impairment, quality of life and end-of-life fear after treatment
timeFrame: Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment
Other outcomes:
Locations:
city: Marburg
country: Germany
facility: Department of Clinical Psychology and Psychotherapy, Philipps University Marburg
city: Schönau am Königssee
country: Germany
facility: Klinikum Berchtesgadener Land, Schön Kliniken
Study officials:
affiliation: Department of Clinical Psychology and Psychotherapy, Philipps University Marburg, Germany
name: Winfried Rief, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinikum Berchtesgadener Land, Schön Kliniken, Schönau a. K., Germany
name: Klaus Kenn, Dr.
role: STUDY_DIRECTOR
affiliation: Department of Clinical Psychology and Psychotherapy, Philipps University Marburg, Germany
name: Sabine R Pinzer, Dipl.-Psych.
role: STUDY_CHAIR
References: