Contact information
Type
Scientific
Primary contact
Mrs Moyra Mills
ORCID ID
Contact details
Epidemiology and Public Health
Mulhouse Building
Royal Victoria Hospital
Grosvenor Road
Belfast
BT12 6BJ
United Kingdom
+44 (0)28 90635059
mmills05@qub.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
To determine if patient held Quality of Life (QoL) tools improve the quality of care and patient quality of life.
Ethics approval
Office of Resarch Ethics Committees Northern Ireland (ORECNI) on 30/11/2004 (ref: 04/NIR01/77)
Study design
A multi-centred randomised controlled trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Lung and oesophageal cancer
Intervention
Patients receive a QoL diary which consists of a core questionnaire (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer patients [EORTC QLQ C-30]) with a Lung (LC-13) or Oesophageal (OES-18) cancer module, in the form of an A5 booklet, which they complete weekly. Patients are encouraged to share their diary with health professionals involved in their care.
The duration of treatment was four months, and at the end of this period outcomes were collected for both arms of the treatment, therefore there is no additional follow-up period for this trial.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The primary outcome is QoL, measured through two questionnaires:
1. Functional Assessment of Cancer Therapy - General questionnaire (FACT-G) with lung and oesophageal modules, measured at the end of month two and month four following recruitment
2. Palliative care quality of life index, measured at the end of month two and month four following recruitment
Secondary outcome measures
Secondary outcomes include:
1. Indices of patient satisfaction, measured at the end of month two and month four following recruitment
2. Impact on carers, measured at the end of month two and month four following recruitment
3. Measures of communication, measured at the end of month two and month four following recruitment
4. Multi-disciplinary nature of patient management, measured at the end of month two and month four following recruitment
Overall trial start date
01/01/2005
Overall trial end date
01/01/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Inoperable lung and oesophageal cancer
2. World Health Organisation (WHO) performance status of zero to two
3. No cognitive impairment
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
150
Participant exclusion criteria
1. Surgically resectable patients
2. WHO performance status of 3+
3. Cognitively impaired patients
Recruitment start date
01/01/2005
Recruitment end date
01/01/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Epidemiology and Public Health
Belfast
BT12 6BJ
United Kingdom
Sponsor information
Organisation
Queen's University Belfast (UK)
Sponsor details
University Road
Belfast
BT7 1NN
United Kingdom
+44 (0)28 90272568
rrs@qub.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Research and Development Office of Northern Ireland (UK) (ref: EAT/2551/03)
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
1. 2008 feasibility results in http://www.ncbi.nlm.nih.gov/pubmed/18842455
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19029416
Publication citations
-
Feasibility results
Mills ME, Murray LJ, Johnston BT, Donnelly M, Feasibility of a standardised quality of life questionnaire in a weekly diary format for inoperable lung cancer patients., Eur J Oncol Nurs, 2008, 12, 5, 457-463, doi: 10.1016/j.ejon.2008.06.003.
-
Results
Mills ME, Murray LJ, Johnston BT, Cardwell C, Donnelly M, Does a patient-held quality-of-life diary benefit patients with inoperable lung cancer?, J. Clin. Oncol., 2009, 27, 1, 70-77, doi: 10.1200/JCO.2008.17.5687.