Back to resultsEffectiveness of a Hand-held Fan for Breathlessness
Primary Purpose
Primary Lung Cancer or Secondary Lung Metastases, COPD III/IV
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
hand-held fan
wristband
Sponsored by
About this trial
This is an interventional treatment trial for Primary Lung Cancer or Secondary Lung Metastases focused on measuring Breathlessness, Dyspnea, Hand-held fan, Palliative Care
Eligibility Criteria
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
Sites / Locations
- King's College London
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
hand-held fan
wristband
Arm Description
Outcomes
Primary Outcome Measures
change of severity of breathlessness
Secondary Outcome Measures
use and acceptance of the intervention and the control
adherence to the study
uptake into the trial (proportion of patients from the longitudinal study participating in the RCT)
change of severity of breathlessness
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01123902
Brief Title
Effectiveness of a Hand-held Fan for Breathlessness
Official Title
Effectiveness of a Hand-held Fan for Breathlessness: a Randomised Phase II Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
King's College London
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Lung Cancer or Secondary Lung Metastases, COPD III/IV
Keywords
Breathlessness, Dyspnea, Hand-held fan, Palliative Care
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
109 (Actual)
8. Arms, Groups, and Interventions
Arm Title
hand-held fan
Arm Type
Experimental
Arm Title
wristband
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
hand-held fan
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
wristband
Intervention Description
Patients are instructed to wear the wristband continually and pull it regularly at short intervals when breathless or during breathlessness attacks.
Primary Outcome Measure Information:
Title
change of severity of breathlessness
Time Frame
between baseline and one month
Secondary Outcome Measure Information:
Title
use and acceptance of the intervention and the control
Time Frame
over 6 months
Title
adherence to the study
Time Frame
6 months
Title
uptake into the trial (proportion of patients from the longitudinal study participating in the RCT)
Time Frame
18 months
Title
change of severity of breathlessness
Time Frame
baseline and two months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia Bausewein, PhD MD MSc
Organizational Affiliation
King's College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
King's College London
City
London
ZIP/Postal Code
SE5 9PJ
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
20958972
Citation
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.
Results Reference
derived
Learn more about this trial
Effectiveness of a Hand-held Fan for Breathlessness
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