Condition category
Cancer
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
05/12/2014
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

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes