Condition category
Cancer
Date applied
10/10/2012
Date assigned
11/10/2012
Last edited
26/08/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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
-
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

http://www.manchester.ac.uk/

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

Publication citations

Additional files

Editorial Notes

26/08/2016: No publications found, verifying study status with principal investigator