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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01138358
First Posted: June 7, 2010
Last Update Posted: August 26, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
  Purpose

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.


Condition Intervention
Dyspnea Lung Cancer Metastatic Cancer Other: medical chart review Other: study of socioeconomic and demographic variables Other: survey administration Procedure: quality-of-life assessment

Study Type: Observational
Official Title: Experiences of Episodic Breathlessness (EB) in Patients With Advanced Disease

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Experiences of episodic breathlessness
  • Impact of episodic breathlessness on daily living
  • Individual coping strategies to reduce burden of episodic breathlessness

Estimated Enrollment: 50
Study Start Date: January 2010
Study Completion Date: October 2012
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01138358


Locations
United Kingdom
King's College Hospital
London, England, United Kingdom, SE5 9RJ
Sponsors and Collaborators
King's College Hospital NHS Trust
Investigators
Principal Investigator: Steffen Simon, MD, MSC King's College Hospital NHS Trust
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT01138358     History of Changes
Other Study ID Numbers: CDR0000674580
UKM-KCH-EB-V4
EU-21039
First Submitted: June 4, 2010
First Posted: June 7, 2010
Last Update Posted: August 26, 2013
Last Verified: June 2010

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Lung Neoplasms
Neoplasm Metastasis
Dyspnea
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms