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Effectiveness of a Hand-held Fan for Breathlessness

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ClinicalTrials.gov Identifier: NCT01123902
Recruitment Status : Completed
First Posted : May 14, 2010
Last Update Posted : May 14, 2010
Sponsor:
Information provided by:
King's College London

Study Description
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Brief Summary:

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.

This 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.

The 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.

The 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.


Condition or disease Intervention/treatment Phase
Primary Lung Cancer or Secondary Lung Metastases COPD III/IV Device: hand-held fan Device: wristband Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of a Hand-held Fan for Breathlessness: a Randomised Phase II Trial
Study Start Date : June 2006
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: hand-held fan Device: hand-held fan
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.
Placebo Comparator: wristband Device: wristband
Patients are instructed to wear the wristband continually and pull it regularly at short intervals when breathless or during breathlessness attacks.


Outcome Measures
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Primary Outcome Measures :
  1. change of severity of breathlessness [ Time Frame: between baseline and one month ]

Secondary Outcome Measures :
  1. use and acceptance of the intervention and the control [ Time Frame: over 6 months ]
  2. adherence to the study [ Time Frame: 6 months ]
  3. uptake into the trial (proportion of patients from the longitudinal study participating in the RCT) [ Time Frame: 18 months ]
  4. change of severity of breathlessness [ Time Frame: baseline and two months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients were included if they reported breathlessness that had an impact on their daily life and were suffering from one of the following conditions:
  • Advanced malignant disease (primary lung cancer or secondary lung metastases/ lung involvement due to cancer)
  • COPD stage III (severe) and IV (very severe) according to GOLD criteria.[7]

Exclusion Criteria:

  • Unable to provide informed consent
  • Too ill to be interviewed and not fluent or illiterate in German
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01123902


Locations
United Kingdom
King's College London
London, United Kingdom, SE5 9PJ
Sponsors and Collaborators
King's College London
Investigators
Principal Investigator: Claudia Bausewein, PhD MD MSc King's College London
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Prof Irene Higginson, King's College London
ClinicalTrials.gov Identifier: NCT01123902     History of Changes
Other Study ID Numbers: CREC 05/06-69
First Posted: May 14, 2010    Key Record Dates
Last Update Posted: May 14, 2010
Last Verified: July 2006

Keywords provided by King's College London:
Breathlessness
Dyspnea
Hand-held fan
Palliative Care

Additional relevant MeSH terms:
Dyspnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms