| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN58789949 |
| Date ISRCTN assigned | 25/06/2007 |
| Local reference number(s) | N/A |
| Public title | A randomised controlled trial of a patient-held quality of life record in patients with inoperable lung and oesophageal cancer |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Lung and oesophageal cancer |
| Study hypothesis | To determine if patient held Quality of Life (QoL) tools improve the quality of care and patient quality of life. |
| Design/methodology | A multi-centred randomised controlled trial. |
| Research ethics review | Approval given by Office of Resarch Ethics Committees Northern Ireland (ORECNI) on the 30th November 2004 (ref: 04/NIR01/77). |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Inoperable lung and oesophageal cancer
2. World Health Organisation (WHO) performance status of zero to two
3. No cognitive impairment |
| Participants - exclusion criteria | 1. Surgically resectable patients
2. WHO performance status of 3+
3. Cognitively impaired patients |
| Patient information material |
|
| Anticipated start date | 01/01/2005 |
| Anticipated end date | 01/01/2007 |
| Status of trial | Completed |
| Target number of participants | 150 |
| Interventions | 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. |
| 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 |
| 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 |
| Sources of funding | Research and Development Office of Northern Ireland (UK) (ref: EAT/2551/03) |
| Sponsor name | Queen's University Belfast (UK) |
| Sponsor details | University Road
Belfast
United Kingdom
BT7 1NN |
| Sponsor telephone | +44 (0)28 90272568 |
| Sponsor fax | +44 (0)28 90272570 |
| Sponsor email | rrs@qub.ac.uk |
| Sponsor website | http://www.qub.ac.uk |
| Contact name | Mrs Moyra Mills |
| Contact details | Epidemiology and Public Health
Mulhouse Building
Royal Victoria Hospital
Grosvenor Road
Belfast
United Kingdom
BT12 6BJ |
| Contact telephone | +44 (0)28 90635059 |
| Contact email | mmills05@qub.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN58789949 |
| Date last extracted from ISRCTN register | 17/04/2008 |
