Shortness Of Breath in Lung Cancer
| ISRCTN | ISRCTN49387307 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49387307 |
| Secondary identifying numbers | Version 2 |
- 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
Contact information
Dr Miriam Johnson
Scientific
Scientific
St. Catherine's Hospice
Throxenby Lane
North Yorkshire
Scarborough
YO12 5RE
United Kingdom
Study information
| Study design | Multicentre randomised controlled non-blinded parallel-group study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient 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 | 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 study start date | 01/04/2011 |
| Completion date | 31/03/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
St. Catherine's Hospice
Scarborough
YO12 5RE
United Kingdom
YO12 5RE
United Kingdom
Sponsor information
Hull and East Yorkshire Hospitals NHS Trust (HEYHT) (UK)
Hospital/treatment centre
Hospital/treatment centre
Research and Development Department
Daisy Build 2nd Floor
Castle Hill Hospital
Cottingham
Hull
HU16 5JQ
England
United Kingdom
| Website | http://www.hey.nhs.uk |
|---|---|
"ROR" |
https://ror.org/01b11x021 |
Funders
Funder type
Government
National Institute for Health Research
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | |
| 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.
