Feasibility trial of a respiratory symptom intervention
| ISRCTN | ISRCTN13173844 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13173844 |
| Secondary identifying numbers | 13253 |
- Submission date
- 10/10/2012
- Registration date
- 11/10/2012
- Last edited
- 26/08/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Contact information
Mrs June Warden
Scientific
Scientific
The University of Manchester
School of Nursing, Midwifery and Social Work
Jean McFarlane Building
University Place
Manchester
M13 9PL
United Kingdom
| june.warden@manchester.ac.uk |
Study information
| Study design | Randomised interventional trial |
|---|---|
| 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 | Feasibility randomised trial of a novel non-pharmacological intervention for the management of the respiratory distress symptom cluster (breathlessness, cough, fatigue) in patients with advanced lung cancer |
| Study objectives | The overall purpose of this study is to assess a new intervention promoting effective coping and better management of common lung cancer associated symptoms (i.e. breathlessness, cough, fatigue) and obtain the patients' and carers' views about it. More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=13253 |
| Ethics approval(s) | First MREC, 14 March 2012, ref: 12/NW/0090 |
| Health condition(s) or problem(s) studied | Lung Cancer; small cell and non-small cell |
| Intervention | Non-pharmacological, The core components of the non-pharmacological intervention would be teaching of: 1. Diaphragmatic breathing 2. Cough suppression techniques 3. Acupressure (chest points) |
| Intervention type | Other |
| Primary outcome measure | 1. To explore the impact of a novel non-pharmacological supportive intervention on symptom distress 2. To identify the most valid and sensitive primary outcome measures Measured at baseline, 2 weeks and 12 weeks |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/12/2012 |
| Completion date | 01/09/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | UK Sample Size: 120 |
| Key inclusion criteria | 1. Diagnosed with primary or secondary lung cancer 2. Suffering from refractory breathlessness or cough or fatigue ie. not responding to current treatment for the past 2 weeks (presence of a minimum of two of the three symptoms) 3. In the presence of COPD, in stable condition 4. Karnofsky score>50% and Palliative Performance Scale [24] score of >60% 5. Expected prognosis of at least 3 months 6. 18+ years 7. Able to give informed consent 8. Patients are eligible even without the availability of a caregiver |
| Key exclusion criteria | 1. Unstable COPD or acute exacerbation of COPD 2. Rapidly worsening breathlessness requiring urgent medical intervention 3. Unstable cardiovascular, musculoskeletal or neuromuscular disease 4. Palliative radiotherapy to the chest < 4 weeks 5. Chemotherapy < 2 weeks |
| Date of first enrolment | 01/12/2012 |
| Date of final enrolment | 01/09/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
The University of Manchester
Manchester
M13 9PL
United Kingdom
M13 9PL
United Kingdom
Sponsor information
University of Manchester (UK)
University/education
University/education
Oxford Road
Manchester
M13 9PL
England
United Kingdom
| Website | http://www.manchester.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/027m9bs27 |
Funders
Funder type
Charity
Marie Curie Cancer Care (UK) ref: C16394/A14093
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Marie Curie Cancer Care
- 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 |
Editorial Notes
26/08/2016: No publications found, verifying study status with principal investigator
