Effectiveness of a Hand-held Fan for Breathlessness

King's College London

Status and phase

Completed

Phase 2

Conditions

COPD III/IV

Primary Lung Cancer or Secondary Lung Metastases

Treatments

Device: wristband

Device: hand-held fan

Study type

Interventional

Funder types

Other

Identifiers

NCT01123902

CREC 05/06-69

Details and patient eligibility

About

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.

Enrollment

109 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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