Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:55 PM
Study NCT ID:
NCT01138358
Status:
COMPLETED
Last Update Posted:
2013-08-26
First Post:
2010-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Episodic Breathlessness in Patients With Lung Cancer or Other Advanced Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004417', 'term': 'Dyspnea'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-23', 'studyFirstSubmitDate': '2010-06-04', 'studyFirstSubmitQcDate': '2010-06-04', 'lastUpdatePostDateStruct': {'date': '2013-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Experiences of episodic breathlessness'}, {'measure': 'Impact of episodic breathlessness on daily living'}, {'measure': 'Individual coping strategies to reduce burden of episodic breathlessness'}]}, 'conditionsModule': {'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'], 'conditions': ['Dyspnea', 'Lung Cancer', 'Metastatic Cancer']}, 'referencesModule': {'references': [{'pmid': '23094954', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Gathering information about experiences of episodic breathlessness in patients with advanced disease may help doctors learn more about the disease.\n\nPURPOSE: This clinical trial is studying experiences of episodic breathlessness in patients with lung cancer or other advanced disease.', 'detailedDescription': 'OBJECTIVES:\n\n* 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\\]).\n* To explore the impact of episodic breathlessness on daily living.\n* To explore the individual coping strategies to reduce burden of episodic breathlessness.\n\nOUTLINE: This is a multicenter study.\n\nPatients 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of advanced disease as defined by the following criteria:\n\n * Lung cancer\n\n * Primary lung cancer at all stages (small cell lung cancer \\[SCLC\\] and non-small cell lung cancer \\[NSCLC\\])\n * Cancer at any site with secondary tumor of the lung (lung metastasis)\n * Chronic obstructive pulmonary disease (COPD)\n\n * 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\n * Chronic heart failure (CHF)\n\n * 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\n * Motor neuron disease (MND)\n\n * All patients suffering from breathlessness\n* Suffering from episodic breathlessness as defined above at any level of severity\n\nPATIENT CHARACTERISTICS:\n\n* Able to give informed consent\n* Able to be interviewed\n* No cognitive impairment (clinically judged by the principal investigator)\n* No limited comprehension of the English language\n\nPRIOR CONCURRENT THERAPY:\n\n* Concurrent disease-oriented therapies (e.g., chemotherapy, radiotherapy, or surgery) allowed'}, 'identificationModule': {'nctId': 'NCT01138358', 'briefTitle': 'Study of Episodic Breathlessness in Patients With Lung Cancer or Other Advanced Disease', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Experiences of Episodic Breathlessness (EB) in Patients With Advanced Disease', 'orgStudyIdInfo': {'id': 'CDR0000674580'}, 'secondaryIdInfos': [{'id': 'UKM-KCH-EB-V4'}, {'id': 'EU-21039'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'medical chart review', 'type': 'OTHER'}, {'name': 'study of socioeconomic and demographic variables', 'type': 'OTHER'}, {'name': 'survey administration', 'type': 'OTHER'}, {'name': 'quality-of-life assessment', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE5 9RJ', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': "King's College Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Steffen Simon, MD, MSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "King's College Hospital NHS Trust"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "King's College Hospital NHS Trust", 'class': 'OTHER'}}}}