Psychological distress following rapid diagnosis of lung cancer

ISRCTN	ISRCTN92058339
DOI	https://doi.org/10.1186/ISRCTN92058339
Secondary identifying numbers	N0054119936

Submission date: 12/09/2003
Registration date: 12/09/2003
Last edited: 05/12/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr T Donovan
Scientific

Department of Nursing
University of Liverpool
The Whelan Building, Quadrangle
Brownlow Hill
Liverpool
L69 3GB
United Kingdom

Phone	+44 (0)151 794 5901
Email	abc@email.com

Study information

Study design	Observational cross-sectional study
Primary study design	Observational
Secondary study design	Cross sectional study
Study setting(s)	Hospital
Study type	Other
Scientific title	Psychological distress following rapid diagnosis of lung cancer
Study objectives	Does rapid diagnosis of lung cancer increase psychological morbidity and are patient expectations of care and their experience of treatment related to their psychological state?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cancer: Lung
Intervention	A single centre cross-sectional study aims to identify levels of anxiety, depression and distress in patients following diagnosis of lung cancer. 104 Patients will be randomly selected for inclusion from the Rapid Access Lung Shadow Clinic over a period of 6 months. Once informed consent has been obtained interviews will be conducted by specialist nurses in patient's own homes. Four brief psychometric tests will be performed, Becks Depression Inventory, Self-Trait Anxiety Inventory, The Ways of Coping Questionnaire and the Brief Symptom Inventory. A second and third interview repeating the psychometric tests will be conducted within 7 and 30 days of diagnosis respectively.
Intervention type	Other
Primary outcome measure	The identification of levels of anxiety, depression, and distress as indicators of psychological morbidity will inform and allow the planning of strategic initiatives to support future resource allocation, interprofessional working and improved clinical outcomes.
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/03/2003
Completion date	01/12/2003

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	104
Key inclusion criteria	104 patients will be randomly selected for inclusion from the Rapid Access Lung Shadow Clinic over a period of 6 months. On average 12 patients per week are seen at this clinic and it is assumed that two out of every three patients meet the criteria. There is a 95% probability that the mean state anxiety score of this sample will be within +- 3 points of the population mean.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/03/2003
Date of final enrolment	01/12/2003

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Liverpool

Liverpool
L69 3GB
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

The Cardiothoracic Centre Liverpool NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
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