Effectiveness of a hand-held fan for breathlessness: a randomised phase II trial

Claudia Bausewein, Sara Booth, Marjolein Gysels, Robert Kühnbach, Irene J Higginson, Claudia Bausewein, Sara Booth, Marjolein Gysels, Robert Kühnbach, Irene J Higginson

Abstract

Background: Breathlessness is common and distressing in advanced disease. This phase II study aimed to determine the use and acceptance of a hand-held fan (HHF) to relieve breathlessness, to test the effectiveness of the HHF and to evaluate the recruitment into the study.

Methods: RCT embedded within a longitudinal study testing a HHF over time compared to a wristband. Patients were included in the longitudinal study when suffering from breathlessness due to advanced cancer or COPD III/IV and could opt in the RCT. Primary outcome was use of the HHF and the wristband after two months. Secondary outcomes were recruitment into the trial and change of breathlessness severity after two months, measured on the modified Borg scale. Baseline data were collected in a personal interview and follow-up data by monthly postal questionnaires.

Results: 109 patients were recruited in the longitudinal study of which 70 patients (64%) participated in the RCT. Non-participants had statistically significant less breathlessness (Borg mean 2.6 (SD 1.48) versus 3.7 (SD 1.83); p = 0.003) and a better functional status (Karnofsky status mean 61.9 (SD 11.2) versus 66.7 (SD 11.0); p = 0.03). Attrition due to drop out or death was high in both groups. After two months, about half of the patients used the HHF but only 20% the wristband without a statistical difference (Fisher's exact test p = 0.2). 9/16 patients judged the HHF as helpful after two months and 4/5 patients the wristband. There was no difference in mean breathlessness change scores between the HHF (Borg change score: mean 0.6 (SD 2.10)) and the wristband (mean 0.8 (SD 2.67)) after two months (p = 0.90).

Conclusions: Symptom burden and low functional status did not restrain patients from participation in the study. Finding a control for a visible intervention is challenging and needs careful consideration to what is acceptable to patients. The preliminary evidence of effectiveness of the HHF could not be proved. Patients often stopped using the HHF but a small group seemed to benefit which was not necessarily related to a relief in breathlessness. Therefore, more work is necessary on selecting and identifying those who might benefit from the HHF.

Trial registration: ClinicalTrials.gov Identifier: NCT01123902.

Figures

Figure 1
Figure 1
CONSORT diagram showing the flow of patients through the study.
Figure 2
Figure 2
Use of HHF (n = 38) and wristband (n = 32) over time. (note: numbers in bars are absolute numbers)

References

    1. Gysels M, Higginson IJ. Access to services for patients with chronic obstructive pulmonary disease: the invisibility of breathlessness. J Pain Symptom Manage. 2008;36(5):451–60. doi: 10.1016/j.jpainsymman.2007.11.008.
    1. Booth S, Moosavi SH, Higginson IJ. The etiology and management of intractable breathlessness in patients with advanced cancer: a systematic review of pharmacological therapy. Nat Clin Pract Oncol. 2008;5(2):90–100. doi: 10.1038/ncponc1034.
    1. Bausewein C, Booth S, Gysels M, Higginson I. Non-pharmacological interventions for breathlessness in advanced stages of malignant and non-malignant diseases. Cochrane Database Syst Rev. 2008. p. CD005623.
    1. Schwartzstein RM, Lahive K, Pope A, Weinberger SE, Weiss JW. Cold facial stimulation reduces breathlessness induced in normal subjects. American Review of Respiratory Disease. 1987;136(1):58–61.
    1. Baltzan M. Fan to palliate exercise-induced dyspnea with severe COPD [abstract] American Journal of Respiratory and Critical Care Medicine. 2000;161(3 Suppl):A59.
    1. Galbraith S, Fagan P, Perkins P, Lynch A, Booth S. Does the use of a handheld fan improve intractable breathlessness? Journal of Pain & Symptom Management 2009. 2009. in press .
    1. Bausewein C, Booth S, Gysels M, Kuhnbach R, Haberland B, Higginson IJ. Individual breathlessness trajectories do not match summary trajectories in advanced cancer and chronic obstructive pulmonary disease: results from a longitudinal study. Palliat Med. 2010. in press .
    1. GOLD, Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management and prevention of chronic obstructive lung disease; updated report. 2007.
    1. Pocock S. Clincial trials A practical approach. Chichester: John Wiley & Sons; 1983.
    1. Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377–81.
    1. Burdon JGW, Juniper EF, Killian KJ, Hargreave FE, Campbell EJM. The perception of breathlessness in asthma. American Review of Respiratory Disease. 1982;126:825–8.
    1. Dorman S, Jolley C, Abernethy A, Currow D, Johnson M, Farquhar M. et al.Researching breathlessness in palliative care: consensus statement of the National Cancer Research Institute Palliative Care Breathlessness Subgroup. Palliat Med. 2009;23(3):213–27. doi: 10.1177/0269216309102520.
    1. Booth S, Kelly MJ, Cox NP, Adams L, Guz A. Does oxygen help dyspnea in patients with cancer? Am J Respir Crit Care Med. 1996;153(5):1515–8.
    1. Cohen J. Statistical power analysis for the behavioral sciences. Second. Hillsdale: Lawrence Earlbaum Associates; 1988.
    1. White C, Hardy J. Gatekeeping from palliative care research. Progress in Palliative Care. 2008;16(4):167–71. doi: 10.1179/096992608X346189.
    1. King M, Nazareth I, Lampe F, Bower P, Chandler M, Morou M. et al.Impact of participant and physician intervention preferences on randomized trials: a systematic review. JAMA. 2005;293(9):1089–99. doi: 10.1001/jama.293.9.1089.
    1. Preference Collaborative Review Group. Patients' preferences within randomised trials: systematic review and patient level meta-analysis. BMJ. 2008;337:a1864. doi: 10.1136/bmj.a1864.
    1. Mann H, Djulbegovic B. Choosing a control intervention for a randomised clinical trial. BMC Med Res Methodol. 2003;3:7. doi: 10.1186/1471-2288-3-7.
    1. American Thoracic Society. Dyspnea: Mechanisms, Assessment and Management: A Consensus Statement. Am J Resp Crit Care Med. 1999;159:321–40.

Source: PubMed

스폰서 및 공동 작업자

건강 상태

약물 개입

3
구독하다