Effectiveness of a Hand-held Fan for Breathlessness

King's College London109 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

109

Conditions

Primary Lung Cancer or Secondary Lung Metastases COPD III/IV

Interventions

hand-held fanDEVICE

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.

wristbandDEVICE

Patients are instructed to wear the wristband continually and pull it regularly at short intervals when breathless or during breathlessness attacks.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

change of severity of breathlessness

Time frame: between baseline and one month

Secondary Outcomes

use and acceptance of the intervention and the control

Time frame: over 6 months

adherence to the study

Time frame: 6 months

uptake into the trial (proportion of patients from the longitudinal study participating in the RCT)

Time frame: 18 months