Effectiveness of a Hand-held Fan for Breathlessness

Phase 2

Completed

• Conditions: Primary Lung Cancer or Secondary Lung Metastases; COPD III/IV
• Interventions: Device: hand-held fan; Device: wristband

• Registration Number: NCT01123902
• Lead Sponsor: King's College London

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Status Verified: 2006-07
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Study First Submitted: 2010-05-11
• Study First Submitted QC: 2010-05-13
• Last Update Submitted: 2010-05-13
• Study First Posted: 2010-05-14
• Last Update Posted: 2010-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hand-held fan	hand-held fan	-
wristband	wristband	-

Primary Outcome Measures

Name	Time	Method
change of severity of breathlessness	between baseline and one month

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

King's College London; 🇬🇧 London, United Kingdom