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 designA multi-centred randomised controlled trial.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeQuality 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 objectivesTo 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) studiedLung and oesophageal cancer
InterventionPatients 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 typeOther
Primary outcome measureThe 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 measuresSecondary 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 date01/01/2005
Completion date01/01/2007

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants150
Key inclusion criteria1. Inoperable lung and oesophageal cancer
2. World Health Organisation (WHO) performance status of zero to two
3. No cognitive impairment
Key exclusion criteria1. Surgically resectable patients
2. WHO performance status of 3+
3. Cognitively impaired patients
Date of first enrolment01/01/2005
Date of final enrolment01/01/2007

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 logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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