Condition category
Cancer
Date applied
13/02/2009
Date assigned
05/03/2009
Last edited
18/01/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Miriam Johnson

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 2

Study information

Scientific title

Non-pharmacological management of breathlessness: a randomised controlled trial of different intensity training

Acronym

SOB-LC

Study hypothesis

Training in breathlessness techniques in a programme of three sessions is more beneficial than training in a single session.

Ethics approval

Hull and East Riding Local Ethics Research Ethics Committee gave approval in January 2008 (ref: 07/Q1104/2)

Study design

Single centre randomised controlled non-blinded parallel group feasibility study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

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 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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/09/2007

Overall trial end date

30/09/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant 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

Recruitment start date

01/09/2007

Recruitment end date

30/09/2008

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 (UK)

Sponsor details

Research and Development Department
2nd Floor
Daisy Building
Castle Hill Hospital
Hull and East Yorkshire Hospitals NHS Trust
Hull
HU16 5JQ
United Kingdom
+44 (0)1482 461903
james.illingworth@hey.nhs.uk

Sponsor type

Government

Website

http://www.hey.nhs.uk/

Funders

Funder type

Government

Funder name

National Cancer Research Institute (NCRI) Supportive and Palliative Care (SuPaC) Research Collaboration (UK) (ref: SuPaC CBG 15; awarded October 2006)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20392515

Publication citations

  1. Results

    Barton R, English A, Nabb S, Rigby AS, Johnson MJ, A randomised trial of high vs low intensity training in breathing techniques for breathless patients with malignant lung disease: a feasibility study., Lung Cancer, 2010, 70, 3, 313-319, doi: 10.1016/j.lungcan.2010.03.007.

Additional files

Editorial Notes