NCT01138358

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 7, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

August 26, 2013

Status Verified

June 1, 2010

Enrollment Period

7 months

First QC Date

June 4, 2010

Last Update Submit

August 23, 2013

Conditions

DyspneaLung CancerMetastatic Cancer

Keywords

dyspnealung metastasesrecurrent non-small cell lung cancerrecurrent small cell lung cancerextensive stage small cell lung cancerstage IIIA non-small cell lung cancerstage IIIB non-small cell lung cancerstage IV non-small cell lung cancer

Outcome Measures

Primary Outcomes (3)

  • Experiences of episodic breathlessness

  • Impact of episodic breathlessness on daily living

  • Individual coping strategies to reduce burden of episodic breathlessness

Interventions

medical chart reviewOTHER
study of socioeconomic and demographic variablesOTHER
survey administrationOTHER
quality-of-life assessmentPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

King's College Hospital

London, England, SE5 9RJ, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 23094954DERIVED

MeSH Terms

Conditions

DyspneaLung NeoplasmsNeoplasm MetastasisCarcinoma, Non-Small-Cell LungSmall Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesNeoplastic ProcessesPathologic ProcessesCarcinoma, BronchogenicBronchial Neoplasms

Study Officials

  • Steffen Simon, MD, MSC

    King's College Hospital NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 4, 2010

First Posted

June 7, 2010

Study Start

January 1, 2010

Primary Completion

August 1, 2010

Study Completion

October 1, 2012

Last Updated

August 26, 2013

Record last verified: 2010-06

Locations

GB(1)