Breathlessness training: comparison of two programmes for Shortness Of Breath in Lung Cancer
| ISRCTN | ISRCTN62865905 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62865905 |
| Secondary identifying numbers | Version 2 |
- Submission date
- 13/02/2009
- Registration date
- 05/03/2009
- Last edited
- 17/03/2020
- 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
Not provided at time of registration
Contact information
Dr Miriam Johnson
Scientific
Scientific
St. Catherine's Hospice
Throxenby Lane
Scarborough
YO12 5RE
United Kingdom
Study information
| Study design | Single centre randomised controlled non-blinded parallel group feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Non-pharmacological management of breathlessness: a randomised controlled trial of different intensity training |
| Study acronym | SOB-LC |
| Study objectives | Training in breathlessness techniques in a programme of three sessions is more beneficial than training in a single session. |
| Ethics approval(s) | Hull and East Riding Local Ethics Research Ethics Committee gave approval in January 2008 (ref: 07/Q1104/2) |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/09/2007 |
| Completion date | 30/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2007 |
| Date of final enrolment | 30/09/2008 |
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 (UK)
Hospital/treatment centre
Hospital/treatment centre
Research and Development Department
2nd Floor, Daisy Building
Castle Hill Hospital
Hull and East Yorkshire Hospitals NHS Trust
Hull
HU16 5JQ
England
United Kingdom
| Phone | +44 (0)1482 461903 |
|---|---|
| james.illingworth@hey.nhs.uk | |
| Website | http://www.hey.nhs.uk/ |
"ROR" |
https://ror.org/01b11x021 |
Funders
Funder type
Government
National Cancer Research Institute (NCRI) Supportive and Palliative Care (SuPaC) Research Collaboration (UK) (ref: SuPaC CBG 15; awarded October 2006)
No information available
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2010 | Yes | No |
Editorial Notes
17/03/2020: Internal review.
