A randomised controlled trial of a patient-held quality of life record in patients with inoperable lung and oesophageal cancer
ISRCTN | ISRCTN58789949 |
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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
Scientific
Epidemiology and Public Health
Mulhouse Building
Royal Victoria Hospital
Grosvenor Road
Belfast
BT12 6BJ
United Kingdom
Phone | +44 (0)28 90635059 |
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mmills05@qub.ac.uk |
Study information
Study design | A multi-centred randomised controlled trial. |
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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 |
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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
BT12 6BJ
United Kingdom
Sponsor information
Queen's University Belfast (UK)
University/education
University/education
University Road
Belfast
BT7 1NN
Northern Ireland
United Kingdom
Phone | +44 (0)28 90272568 |
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rrs@qub.ac.uk | |
Website | http://www.qub.ac.uk |
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 | |
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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? |
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Results article | feasibility results | 01/12/2008 | Yes | No | |
Results article | results | 01/01/2009 | Yes | No |