Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Mrs June Warden
ORCID ID
Contact details
The University of Manchester
School of Nursing
Midwifery and Social Work
Jean McFarlane Building
University Place
Manchester
M13 9PL
United Kingdom
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june.warden@manchester.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
13253
Study information
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
Acronym
Study hypothesis
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
First MREC, 14 March 2012, ref: 12/NW/0090
Study design
Randomised interventional trial
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
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/12/2012
Overall trial end date
01/09/2013
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
UK Sample Size: 120
Participant 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
Recruitment start date
01/12/2012
Recruitment end date
01/09/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The University of Manchester
Manchester
M13 9PL
United Kingdom
Sponsor information
Organisation
University of Manchester (UK)
Sponsor details
Oxford Road
Manchester
M13 9PL
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Marie Curie Cancer Care (UK) ref: C16394/A14093
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
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