Study of Episodic Breathlessness in Patients With Lung Cancer or Other Adva... | Completed
Study of Episodic Breathlessness in... | Completed
Study of Episodic Breathlessness in Patients With Lung Cancer or Other Advanced Disease

Trial Source

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Medical Conditions
  • Dyspnea
  • Lung Cancer
  • Metastatic Cancer
Unfortunately contact details are not available for this trial.
Primary Contact Details
Completed
Recruitment Status
NCT01138358
Primary Trial ID Number

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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.
Research Details
  • 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.
Phase
N/A
Study Design
N/A
Study Type
Observational
Intervention
Other : medical chart review, Other : study of socioeconomic and demographic variables, Other : survey administration, Procedure : quality-of-life assessment

Study Arm Groups : , , ,

Intervention Type
See Interventions above
Primary Outcome Measures
    Experiences of episodic breathlessness; null; Impact of episodic breathlessness on daily living; null; Individual coping strategies to reduce burden of episodic breathlessness; null
Secondary Outcome Measures
    Sorry, this information is not available
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
50
Participant Inclusion 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
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Academic Dept of Rheumatology, Kings College London
London
SE5 9RJ
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
Experiences of Episodic Breathlessness (EB) in Patients With Advanced Disease
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
CDR0000674580
Sponsor(s)
King's College Hospital NHS Trust
Key Dates

Recruitment Start Date

Jan 2010

Recruitment End Date

Aug 2010

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

04 Jun 2010

Date updated in source

23 Aug 2013