Shortness Of Breath in Lung Cancer

ISRCTN	ISRCTN49387307
DOI	https://doi.org/10.1186/ISRCTN49387307
Protocol serial number	Version 2
Sponsor	Hull and East Yorkshire Hospitals NHS Trust (HEYHT) (UK)
Funder	National Institute for Health Research

Submission date: 25/08/2010
Registration date: 25/01/2011
Last edited: 25/10/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-comparing-2-training-programmes-manage-breathlessness-people-with-cancer-affecting-lungs-sob-lc2

Contact information

Dr Miriam Johnson
Scientific

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

Study information

Primary study design	Interventional
Study design	Multicentre randomised controlled non-blinded parallel-group study
Secondary study design	Randomised parallel trial
Study type	Participant information sheet
Scientific title	A randomised trial of high versus low intensity training in breathing techniques for breathlessness in patients with malignant lung disease: early intervention
Study acronym	SOB-LC II
Study objectives	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(s)	Sheffield Research Ethics Committee, 15/12/2010, ref: 10/H1308/66
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Worst severity of breathlessness over past 24 hours measured by NRS
Key secondary outcome measure(s)	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.
Completion date	31/03/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	146
Total final enrolment	156
Key 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
Key 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
Date of first enrolment	25/05/2011
Date of final enrolment	31/03/2013

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

St. Catherine's Hospice

Scarborough
YO12 5RE
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	cost-effectiveness results	01/11/2014		Yes	No
Results article	results	07/09/2015		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results			25/10/2022	No	Yes

Editorial Notes

25/10/2022: Cancer Research UK plain English results link and total final enrolment added.
06/02/2017: Publication reference added.