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
Protocol serial number	N/A
Sponsor	Queen's University Belfast (UK)
Funder	Research and Development Office of Northern Ireland (UK) (ref: EAT/2551/03)

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

Primary study design	Interventional
Study design	A multi-centred randomised controlled trial.
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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
Key secondary outcome measure(s)	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
Completion date	01/01/2007

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	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

United Kingdom
Northern Ireland

Study participating centre

Epidemiology and Public Health

Belfast
BT12 6BJ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes