Effectiveness of a Hand-held Fan for Breathlessness

NCT01123902 | Completed Phase 2

• 1 other identifier: CREC 05/06-69
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Lung Cancer or Secondary Lung Metastases; COPD III/IV

Keywords

Breathlessness; Dyspnea; Hand-held fan; Palliative Care

Outcome Measures

Primary Outcomes (1)

• change of severity of breathlessness

  between baseline and one month

Secondary Outcomes (4)

• 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

Study Arms (2)

hand-held fan

EXPERIMENTAL

Device: hand-held fan

wristband

PLACEBO COMPARATOR

Device: wristband

Interventions

hand-held fan DEVICE

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.

hand-held fan

wristband DEVICE

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

wristband

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.\[7\]

You may not qualify if:

• Unable to provide informed consent
• Too ill to be interviewed and not fluent or illiterate in German

Sponsors & Collaborators

• King's College London: lead

Study Sites (1)

King's College London

London, SE5 9PJ, United Kingdom

Location

Related Publications (1)

• Bausewein C, Booth S, Gysels M, Kuhnbach R, Higginson IJ. Effectiveness of a hand-held fan for breathlessness: a randomised phase II trial. BMC Palliat Care. 2010 Oct 19;9:22. doi: 10.1186/1472-684X-9-22.

  PMID: 20958972 DERIVED

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Claudia Bausewein, PhD MD MSc

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 11, 2010
• First Posted: May 14, 2010
• Study Start: June 1, 2006
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: May 14, 2010

Record last verified: 2006-07

Locations

GB (1)