Study of Episodic Breathlessness in Patients With Lung Cancer or Other Advanced Disease
Recruitment status was Recruiting
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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 |
- 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 |
| Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
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 |
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| United Kingdom | |
| King's College Hospital | Recruiting |
| London, England, United Kingdom, SE5 9RJ | |
| Contact: Contact Person 44-20-7848-5507 steffen@steffensimon.de | |
| 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: | June 4, 2010 |
| 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 Neoplasms Neoplasms, Second Primary Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Neoplastic Processes Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013