Condition category
Cancer
Date applied
01/06/2007
Date assigned
25/06/2007
Last edited
17/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.qub.ac.uk

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

  1. 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.

  2. 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.

Additional files

Editorial Notes