Condition category
Cancer
Date applied
25/08/2010
Date assigned
25/01/2011
Last edited
09/09/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Miriam Johnson

ORCID ID

Contact details

St. Catherine's Hospice
Throxenby Lane
North Yorkshire
Scarborough
YO12 5RE
United Kingdom

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 below 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

http://www.hey.nhs.uk

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

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26345362

Publication citations

Additional files

Editorial Notes