Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Version 2
Study information
Scientific title
A randomised trial of high versus low intensity training in breathing techniques for breathlessness in patients with malignant lung disease: early intervention
Acronym
SOB-LC II
Study hypothesis
Three breathing training sessions at weekly intervals are more effective than a single session in reducing the breathlessness severity of patients with intra-thoracic malignancy and refractory breathlessness.
Please note that this record is related to a previously registered trial entitled "Breathlessness training: comparison of two programmes for Shortness Of Breath in Lung Cancer" (ISRCTN62865905), and can be found at http://www.isrctn.com/ISRCTN62865905.
Ethics approval
Sheffield Research Ethics Committee, 15/12/2010, ref: 10/H1308/66
Study design
Multicentre randomised controlled non-blinded parallel-group study
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Intrathoracic cancer
Intervention
Patients randomised to the single session training arm will be taught the four techniques of management of breathlessness (breathing control, pacing, anxiety management and relaxation) at a single session in a clinical setting appropriate to the needs of the patient by the therapist.
Patients randomised to the three session training arm will be taught the same four techniques of the management of breathlessness at a 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.
Both groups will receive written reinforcement in the form of information booklets plus verbal reinforcement in the format of the patients choice (CD, 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.
The primary analysis point is a 4 weeks, but participants will be followed up until 8 weeks.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measures
Worst severity of breathlessness over past 24 hours measured by NRS
Secondary outcome measures
1. Breathlessness score on NRS (severity: average over last 24 hours)
2. NRS distress from breathlessness
3. NRS satisfaction with care of breathlessness
4. Global impression of changes of breathlessness
5. CRQ-SAS
6. HADS
7. Brief COPE/NRS cope
8. EQ5D
9. CIEQ-Chr
10. Number of other interventions for breathlessness during study period
11. Number of hospital admissions during study period
12. Costs associated with both comparators
13. Correlation with baseline BFI, MTQ, CIEQ-Chr scores
14. Correlation with patient programme preference
The following are measured at all time points: breathlessness severity (average over past 24 hours); distress due to, coping with, and satisfaction with the management of breathlessness; EQ5D. All secondary endpoints are measured at weeks 4 and 8 except for the global impression of change of breathlessness which is only measured at week 4.
Overall trial start date
01/04/2011
Overall trial end date
31/03/2013
Reason abandoned
Eligibility
Participant inclusion criteria
1. Primary or secondary malignant lung disease
2. Aged over 18 years
3. Willingness to engage with breathlessness training
4. Ability to give informed consent
5. Sufficient understanding of the English language to complete the study questionnaires
6. Severity average breathlessness (Numeric Rating Scale [NRS]) greater than 3
7. All identified reversible causes of the breathlessness have been treated if appropriate to do so, in the opinion of the attending clinician
8. Verbal confirmation of consent
9. Estimated prognosis (in the investigator's opinion) of greater than 3 months
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
146
Participant exclusion criteria
1. Inability to give informed consent
2. Intercurrent illness or co-morbidities making completion of the study unlikely
3. Rapidly worsening breathlessness requiring urgent medical intervention
4. Insufficient understanding of the English language to complete the study questionnaires
5. Verbal withdrawal of consent
6. Unable to complete study assessments
Recruitment start date
25/05/2011
Recruitment end date
31/03/2013
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 (HEYHT) (UK)
Sponsor details
Research and Development Department
Daisy Build 2nd Floor
Castle Hill Hospital
Cottingham
Hull
HU16 5JQ
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
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
Results - basic reporting
Publication summary
2014 cost-effectiveness results in: http://www.ncbi.nlm.nih.gov/pubmed/28142878
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26345362