Contact information
Type
Scientific
Primary contact
Mr T Donovan
ORCID ID
Contact details
Department of Nursing
University of Liverpool
The Whelan Building
Quadrangle
Brownlow Hill
Liverpool
L69 3GB
United Kingdom
+44 (0)151 794 5901
abc@email.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0054119936
Study information
Scientific title
Psychological distress following rapid diagnosis of lung cancer
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Observational cross-sectional study
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
01/03/2003
Overall trial end date
01/12/2003
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
104
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/03/2003
Recruitment end date
01/12/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Liverpool
Liverpool
L69 3GB
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
The Cardiothoracic Centre Liverpool NHS Trust (UK)
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
Basic results (scientific)
Publication list