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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01138358
First received: June 4, 2010
Last updated: August 23, 2013
Last verified: June 2010
  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 [ Designated as safety issue: No ]
  • Impact of episodic breathlessness on daily living [ Designated as safety issue: No ]
  • Individual coping strategies to reduce burden of episodic breathlessness [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided by National Cancer Institute (NCI)

Additional 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
Study First Received: June 4, 2010
Last Updated: August 23, 2013
Health Authority: Unspecified

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

ClinicalTrials.gov processed this record on October 22, 2014