Clinical trial NCT01138358: Study of Episodic Breathlessness in Patients With Lung Cancer or Other Advanced Disease
Official title: Experiences of Episodic Breathlessness (EB) in Patients With Advanced Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dyspnea
Lung Cancer
Metastatic Cancer
Keywords: dyspnea
lung metastases
recurrent non-small cell lung cancer
recurrent small cell lung cancer
extensive stage small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2010-06-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: RATIONALE: Gathering information about experiences of episodic breathlessness in patients with advanced disease may help doctors learn more about the disease.

PURPOSE: This clinical trial is studying experiences of episodic breathlessness in patients with lung cancer or other advanced disease.

Detailed description: OBJECTIVES:

* To explore the experiences of episodic breathlessness in patients with advanced disease (i.e., primary and secondary lung cancer, chronic obstructive pulmonary disease \[COPD\], chronic heart failure \[CHF\], and motor neuron disease \[MND\]).
* To explore the impact of episodic breathlessness on daily living.
* To explore the individual coping strategies to reduce burden of episodic breathlessness.

OUTLINE: This is a multicenter study.

Patients undergo 1 to 2 interviews to collect data on experiences of breathlessness (in general, at rest, and on exertion including symptom description, interpretation, and meaning); experiences of episodic breathlessness (EB) (at rest and on exertion including symptom description, interpretation, meaning, and definition); trajectory/course of EB (onset/relief, time, and severity) and different types/trajectories of EB; impact of EB (burden, emotional reaction \[panic and fear\], care burden, and dependencies); triggers of EB (causes, situation, and settings) and predictability of EB; management of EB (coping strategies, non-pharmacological and pharmacological management \[including different applications\], worsen/relief, role of care in coping, and emotional/behavior strategies; views on and experiences with services/professionals in management of EB and response to professional advice; and attitudes towards the future, course of the disease, and awareness of prognosis. At the end of the interview, the patient will be asked to draw a figure that illustrates the trajectory of the episode. After the interview, a debriefing will be carried out to give the patient the chance to express worries, potential harm, or any comments about the interview. In addition to the interviews, further information will be collected including demographics, diagnosis and co-morbidities, current pharmacological and non-pharmacological treatments (medical history), functional status (Karnofsky), and breathlessness characteristics (e.g., intensity, frequency, and duration). The interviews will be tape-recorded, transcribed verbatim, and analyzed concurrently using Framework Approach.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of advanced disease as defined by the following criteria:

  * 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 tumor of the lung (lung metastasis)
  * Chronic obstructive pulmonary disease (COPD)

    * Stage III or IV of the Global Initiative for Obstructive Lung Disease (GOLD) classification, which includes the airflow limitation measured by spirometry FEV1 \< 50%, FEV1/FVC \< 0.7, and symptoms such as more severe breathlessness, reduced exercise capacity, and repeated exacerbations
  * Chronic heart failure (CHF)

    * NYHA class II-IV heart disease, which includes symptoms such as dyspnea or palpitation and an increasing limitation of exercise capacity or discomfort at rest
  * Motor neuron disease (MND)

    * All patients suffering from breathlessness
* Suffering from episodic breathlessness as defined above at any level of severity

PATIENT CHARACTERISTICS:

* Able to give informed consent
* Able to be interviewed
* No cognitive impairment (clinically judged by the principal investigator)
* No limited comprehension of the English language

PRIOR CONCURRENT THERAPY:

* Concurrent disease-oriented therapies (e.g., chemotherapy, radiotherapy, or surgery) allowed

Primary outcomes:
measure: Experiences of episodic breathlessness
measure: Impact of episodic breathlessness on daily living
measure: Individual coping strategies to reduce burden of episodic breathlessness
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College Hospital
state: England
Study officials:
affiliation: King's College Hospital NHS Trust
name: Steffen Simon, MD, MSC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Simon ST, Niemand AM, Benalia H, Voltz R, Higginson IJ, Bausewein C. Acceptability and preferences of six different routes of drug application for acute breathlessness: a comparison study between the United Kingdom and Germany. J Palliat Med. 2012 Dec;15(12):1374-81. doi: 10.1089/jpm.2012.0249. Epub 2012 Oct 24.