A randomised controlled trial of a patient-held quality of life record in patients with inoperable lung and oesophageal cancer

ISRCTN	ISRCTN58789949
DOI	https://doi.org/10.1186/ISRCTN58789949
Secondary identifying numbers	N/A

Submission date: 01/06/2007
Registration date: 25/06/2007
Last edited: 17/08/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs Moyra Mills
Scientific

Epidemiology and Public Health
Mulhouse Building
Royal Victoria Hospital
Grosvenor Road
Belfast
BT12 6BJ
United Kingdom

Phone	+44 (0)28 90635059
Email	mmills05@qub.ac.uk

Study information

Study design	A multi-centred randomised controlled trial.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectives	To determine if patient held Quality of Life (QoL) tools improve the quality of care and patient quality of life.
Ethics approval(s)	Office of Resarch Ethics Committees Northern Ireland (ORECNI) on 30/11/2004 (ref: 04/NIR01/77)
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/01/2005
Completion date	01/01/2007

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	150
Key inclusion criteria	1. Inoperable lung and oesophageal cancer 2. World Health Organisation (WHO) performance status of zero to two 3. No cognitive impairment
Key exclusion criteria	1. Surgically resectable patients 2. WHO performance status of 3+ 3. Cognitively impaired patients
Date of first enrolment	01/01/2005
Date of final enrolment	01/01/2007

Locations

Countries of recruitment

Northern Ireland
United Kingdom

Study participating centre

Epidemiology and Public Health

Belfast
BT12 6BJ
United Kingdom

Sponsor information

Queen's University Belfast (UK)
University/education

University Road
Belfast
BT7 1NN
Northern Ireland
United Kingdom

Phone	+44 (0)28 90272568
Email	rrs@qub.ac.uk
Website	http://www.qub.ac.uk
"ROR"	https://ror.org/00hswnk62

Funders

Funder type

Government

Research and Development Office of Northern Ireland (UK) (ref: EAT/2551/03)

No information available

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	feasibility results	01/12/2008		Yes	No
Results article	results	01/01/2009		Yes	No