Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:21 AM
Study NCT ID:
NCT01123902
Status:
COMPLETED
Last Update Posted:
2010-05-14
First Post:
2010-05-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of a Hand-held Fan for Breathlessness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004417', 'term': 'Dyspnea'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-07', 'completionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-05-13', 'studyFirstSubmitDate': '2010-05-11', 'studyFirstSubmitQcDate': '2010-05-13', 'lastUpdatePostDateStruct': {'date': '2010-05-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change of severity of breathlessness', 'timeFrame': 'between baseline and one month'}], 'secondaryOutcomes': [{'measure': 'use and acceptance of the intervention and the control', 'timeFrame': 'over 6 months'}, {'measure': 'adherence to the study', 'timeFrame': '6 months'}, {'measure': 'uptake into the trial (proportion of patients from the longitudinal study participating in the RCT)', 'timeFrame': '18 months'}, {'measure': 'change of severity of breathlessness', 'timeFrame': 'baseline and two months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Breathlessness', 'Dyspnea', 'Hand-held fan', 'Palliative Care'], 'conditions': ['Primary Lung Cancer or Secondary Lung Metastases', 'COPD III/IV']}, 'referencesModule': {'references': [{'pmid': '20958972', 'type': 'DERIVED', 'citation': 'Bausewein C, Booth S, Gysels M, Kuhnbach R, Higginson IJ. Effectiveness of a hand-held fan for breathlessness: a randomised phase II trial. BMC Palliat Care. 2010 Oct 19;9:22. doi: 10.1186/1472-684X-9-22.'}]}, 'descriptionModule': {'briefSummary': 'Breathlessness is a common and distressing symptom in advanced disease. A hand-held fan is a simple device which has shown, when directed to the patients face, to be effective in relieving breathlessness.\n\nThis phase II trial aims to determine the potential effectiveness of a hand-held fan to relieve breathlessness over time and to evaluate the recruitment into the study and the acceptance of the intervention and the control.\n\nThe intervention to be tested is a HHF directed to the area of the face innervated by the second and third trigeminal nerve branches. A wristband was chosen as control under the assumption that distraction could serve as a placebo.\n\nThe main outcomes for this study are uptake into the trial (proportion of patients from the longitudinal study participating in the RCT), adherence to the study, and use and acceptance of the intervention and the control. The main outcome for assessing the effect of the hand-held fan is change of severity of breathlessness between baseline and one month and two months, respectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients were included if they reported breathlessness that had an impact on their daily life and were suffering from one of the following conditions:\n* Advanced malignant disease (primary lung cancer or secondary lung metastases/ lung involvement due to cancer)\n* COPD stage III (severe) and IV (very severe) according to GOLD criteria.\\[7\\]\n\nExclusion Criteria:\n\n* Unable to provide informed consent\n* Too ill to be interviewed and not fluent or illiterate in German'}, 'identificationModule': {'nctId': 'NCT01123902', 'briefTitle': 'Effectiveness of a Hand-held Fan for Breathlessness', 'organization': {'class': 'OTHER', 'fullName': "King's College London"}, 'officialTitle': 'Effectiveness of a Hand-held Fan for Breathlessness: a Randomised Phase II Trial', 'orgStudyIdInfo': {'id': 'CREC 05/06-69'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'hand-held fan', 'interventionNames': ['Device: hand-held fan']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'wristband', 'interventionNames': ['Device: wristband']}], 'interventions': [{'name': 'hand-held fan', 'type': 'DEVICE', 'description': 'Patients are instructed to direct the hand-held fan towards the face around the central part of the face, the sides of the nose and above the upper lip. The hand-held fan has three soft rotor blades and an unfoldable rotor unit.', 'armGroupLabels': ['hand-held fan']}, {'name': 'wristband', 'type': 'DEVICE', 'description': 'Patients are instructed to wear the wristband continually and pull it regularly at short intervals when breathless or during breathlessness attacks.', 'armGroupLabels': ['wristband']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE5 9PJ', 'city': 'London', 'country': 'United Kingdom', 'facility': "King's College London", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Claudia Bausewein, PhD MD MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "King's College London"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "King's College London", 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Prof Irene Higginson', 'oldOrganization': "King's College London"}}}}