DyspneaNCT01138358
Study of Episodic Breathlessness in Patients With Lung Cancer or Other Advanced Disease
An observational study of Dyspnea and Lung Cancer, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspnea, Lung Cancer, Metastatic Cancer
- What is being tested?
- medical chart review, study of socioeconomic and demographic variables and survey administration
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2010to Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Experiences of Episodic Breathlessness (EB) in Patients With Advanced Disease
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.
Read the 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.
- Conditions
- Dyspnea, Lung Cancer, Metastatic Cancer
- Being tested
- medical chart review, study of socioeconomic and demographic variables, survey administration, quality-of-life assessment
- Keywords
- 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
- Medical subject headings
- Dyspnea, Lung Neoplasms, Neoplasm Metastasis, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical chart reviewOther
study of socioeconomic and demographic variablesOther
survey administrationOther
quality-of-life assessmentProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Experiences of episodic breathlessness
Impact of episodic breathlessness on daily living
Individual coping strategies to reduce burden of episodic breathlessness
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2010 (estimated)
- Study startJan 2010
- Primary completionAug 2010
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyspneaStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Investigators
- Steffen Simon, MD, MSC, Principal investigator, King's College Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01138358
- Sponsor's protocol ID
- CDR0000674580
- Other IDs
- UKM-KCH-EB-V4, EU-21039
- Status last verified
- Jun 2010
- First submitted
- 4 Jun 2010
- Last updated
- 26 Aug 2013
- Results posted
- No
Publications
Simon ST, Niemand AM, Benalia H, Voltz R, Higginson IJ, Bausewein C. Acceptability and preferences of six different routes of drug application for acute breathlessness: a comparison study between the United Kingdom and Germany. J Palliat Med. 2012 Dec;15(12):1374-81. doi: 10.1089/jpm.2012.0249. Epub 2012 Oct 24.
PubMed 23094954
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experiences of Episodic Breathlessness (EB) in Patients With Advanced Disease
- ClinicalTrials.gov ID
- NCT01138358
- Acronym / sponsor ID
- CDR0000674580
- Conditions
- Dyspnea, Lung Cancer, Metastatic Cancer
- Keywords
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 7 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| medical chart review | Other | – |
| study of socioeconomic and demographic variables | Other | – |
| survey administration | Other | – |
| quality-of-life assessment | Procedure or surgery | – |
Primary outcome
Experiences of episodic breathlessness
Impact of episodic breathlessness on daily living
Individual coping strategies to reduce burden of episodic breathlessness
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2013.
- Derived from this study: PubMed 23094954Simon ST, Niemand AM, Benalia H, Voltz R, Higginson IJ, Bausewein C. Acceptability and preferences of six different routes of drug application for acute breathlessness: a comparison study between the United Kingdom and Germany. J Palliat Med. 2012 Dec;15(12):1374-81. doi: 10.1089/jpm.2012.0249. Epub 2012 Oct 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steffen Simon, MD, MSC principal investigator
King's College Hospital NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyspnea and Lung Cancer, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experiences of episodic breathlessness. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01138358, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2013.