Study of Episodic Breathlessness in Patients With Lung Cancer or Other Advanced Disease

Lung Cancer Clinical Trial

Official title:

Experiences of Episodic Breathlessness (EB) in Patients With Advanced Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01138358
• Other study ID #: CDR0000674580
• Secondary ID: UKM-KCH-EB-V4EU-
• Status: Completed
• Phase: N/A
• First received: June 4, 2010
• Last updated: August 23, 2013
• Start date: January 2010
• Est. completion date: October 2012

Study information

• Verified date: June 2010
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2012
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Dyspnea
• Lung Cancer
• Lung Neoplasms
• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Other:
• medical chart review

• study of socioeconomic and demographic variables

• survey administration

Procedure:
• quality-of-life assessment

Locations

Country	Name	City	State
United Kingdom	King's College Hospital	London	England

Sponsors (1)

Lead Sponsor	Collaborator
King's College Hospital NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Experiences of episodic breathlessness			No
Primary	Impact of episodic breathlessness on daily living			No
Primary	Individual coping strategies to reduce burden of episodic breathlessness			No