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

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health 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
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
This is available on the Clinicaltrials.gov website
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
Trial Location(s)
Guy's King's and St. Thomas' School of Medicine
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
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 Assigned

04 Jun 2010

Last Updated

23 Aug 2013