Effectiveness of a Hand-held Fan for Breathlessness

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of a Hand-held Fan for Breathlessness: a Randomised Phase II Trial

Conditions
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Primary Lung Cancer or Secondary Lung Metastases, COPD III/IV

Intervention / Treatment
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* Device: hand-held fan
* Device: wristband


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hand-held fan<br> | Device: hand-held fan<br>* 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.<br>|
| Placebo Comparator: wristband<br> | Device: wristband<br>* Patients are instructed to wear the wristband continually and pull it regularly at short intervals when breathless or during breathlessness attacks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of severity of breathlessness |  | between baseline and one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| use and acceptance of the intervention and the control |  | over 6 months | 
| adherence to the study |  | 6 months | 
| uptake into the trial (proportion of patients from the longitudinal study participating in the RCT) |  | 18 months | 
| change of severity of breathlessness |  | baseline and two months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breathlessness, Dyspnea, Hand-held fan, Palliative Care