Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Version 2
Study information
Scientific title
Non-pharmacological management of breathlessness: a randomised controlled trial of different intensity training
Acronym
SOB-LC
Study hypothesis
Training in breathlessness techniques in a programme of three sessions is more beneficial than training in a single session.
Ethics approval
Hull and East Riding Local Ethics Research Ethics Committee gave approval in January 2008 (ref: 07/Q1104/2)
Study design
Single centre randomised controlled non-blinded parallel group feasibility study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Breathlessness in patients with intrathoracic malignancy
Intervention
Low intensity training programme:
Patients randomised to the low intensity arm will be taught four techniques of management of breathlessness at a single hour long session in a clinical setting appropriate to the needs of the patient by the therapist. They will be taught diaphragmatic breathing and pacing which require face-to-face demonstration. In addition, a brief introduction will be given to techniques to promote relaxation and manage anxiety. Written reinforcement in the form of information booklets plus verbal reinforcement in the format of the patients choice (tape, video or DVD) will be given to remind the patient of the techniques they have been taught.
One week later, the therapist will ring the patient to see if they have remembered to practise the techniques and if they have managed to watch/listen to the reinforcement information.
High intensity training programme:
Patients randomised to the high intensity arm will be taught the same four techniques of the management of breathlessness at a hour long single session in a clinical setting appropriate to the needs of the patient by the therapist. This will be followed by practice and reinforcement face-to-face with the therapist on two further occasions at weekly intervals.
Written reinforcement in the form of information booklets plus verbal reinforcement in the format of the patients choice (tape, video or DVD) will be given to remind the patient of the techniques they have been taught. One week after the final visit, the therapist will ring the patient to see if they have remembered to practise the techniques and if they have managed to watch/listen to the reinforcement information.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Recruitment, retention and variability of breathlessness severity (Numerical Rating Scale [NRS] worst breathlessness over last 24 hours)
Secondary outcome measures
1. NRS average breathlessness over last 24 hours
2. NRS breathlessness "now"
3. NRS distress due to breathlessness
4. NRS coping with breathlessness
5. NRS satisfaction of care
6. Brief COPE
7. Hospital Anxiety and Depression scale (HAD)
8. Euroqol EQ-5D (EQ-5D)
9. Visual Analogue Scale (VAS)
Overall trial start date
01/09/2007
Overall trial end date
30/09/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Intractable breathlessness resulting from primary or secondary malignant lung disease in the palliative setting where the underlying cause has been maximally treated
2. All identified reversible causes of the breathlessness have been treated if appropriate to do so, in the opinion of the attending clinician
3. Karnofsky Performance Status (KPS) greater than 40%
4. Aged greater than 18 years, either sex
5. Willingness to attend for breathlessness training
6. Ability to give informed consent
7. Expected prognosis of at least 3 months in the opinion of the attending clinician
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant exclusion criteria
1. Inability to give informed consent
2. Intercurrent illness or co-morbidities making completion of the physiotherapy breathlessness course (PBC) course unlikely
3. Rapidly worsening breathlessness requiring urgent medical intervention
4. Palliative radiotherapy to chest in previous 4 weeks
5. Radical radiotherapy in previous 6 months
6. Chemotherapy or change in anti-cancer hormone treatment in previous 2 weeks
Recruitment start date
01/09/2007
Recruitment end date
30/09/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St. Catherine's Hospice
Scarborough
YO12 5RE
United Kingdom
Sponsor information
Organisation
Hull and East Yorkshire Hospitals NHS Trust (UK)
Sponsor details
Research and Development Department
2nd Floor
Daisy Building
Castle Hill Hospital
Hull and East Yorkshire Hospitals NHS Trust
Hull
HU16 5JQ
United Kingdom
+44 (0)1482 461903
james.illingworth@hey.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
National Cancer Research Institute (NCRI) Supportive and Palliative Care (SuPaC) Research Collaboration (UK) (ref: SuPaC CBG 15; awarded October 2006)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20392515
Publication citations
-
Results
Barton R, English A, Nabb S, Rigby AS, Johnson MJ, A randomised trial of high vs low intensity training in breathing techniques for breathless patients with malignant lung disease: a feasibility study., Lung Cancer, 2010, 70, 3, 313-319, doi: 10.1016/j.lungcan.2010.03.007.