Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000393752
Ethics application status
Approved
Date submitted
27/03/2013
Date registered
10/04/2013
Date last updated
14/05/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Chest Australia: reducing time to consult with symptoms of lung cancer.
Scientific title
In patients who are at high risk of lung cancer, what is the effect of a complex intervention (comprising a primary-care nurse consultation, self-help manual, and self-monitoring reminders) compared to usual care on consultation rates and time to consultation for chest symptoms associated with lung cancer?
Secondary ID [1] 282199 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chest disease 288717 0
Lung Cancer 288718 0
Condition category
Condition code
Cancer 289065 289065 0 0
Lung - Small cell
Respiratory 289066 289066 0 0
Other respiratory disorders / diseases
Respiratory 289067 289067 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The CHEST intervention is theoretically based and comprises a 40 minute consultation in which a nurse guides the patient through a self-help manual entitled “Chest symptoms that Call for Action”. This aims to increase the salience of chest symptoms, reinforce the benefits of and sanction early presentation, and a discussion of the barriers to presentation. A personalised action plan is developed which is reinforced through regular monthly prompts.(via email, text message or phone). In addition, each patient is given a spirometry test to measure lung function.
Everyone will have a questionaire posted to them to complete at three different time points in the study: at the beginning, at one month, and at 12 months. Also if the patient consults with their GP with chest symptoms during the 12 month study period they will be asked to complete a shorter "Delays" questionnaire about their symptoms. This is a self-completed questionnaire that obtains data on presenting symptoms and their duration prior to consultation. We will monitor every month during the trial the consultations of trial participants through electronic searches of the GP records.
Intervention code [1] 286811 0
Prevention
Intervention code [2] 286847 0
Early detection / Screening
Comparator / control treatment
Standard Treatment. If the patient is allocated to the "Usual Care" arm, they will still have a nurse consultation and a spirometry test, but will not be shown the handbook or have monthly prompts. They will still have the questionaires posted to them at baseline, 1 month and 12 months and if they do consult with respiratory symptoms in this time they also will be sent the "Delays" questionaire.
Control group
Active

Outcomes
Primary outcome [1] 289176 0
The primary outcome of this trial will be consultation rates (with the GP) for respiratory symptoms identified through audit of the general practice medical record.
Timepoint [1] 289176 0
12 months after randomisation.
Secondary outcome [1] 301966 0
Self-efficacy for consulting without delay. This is a 10-item scale summed to score 10-100, within the self completed questionaire given at baseline, one month and 12 months.
Timepoint [1] 301966 0
Measured at baseline, one month and 12 months.
Secondary outcome [2] 301967 0
Symptom Appraisal and help-seeking intervals. This will be measured using the DELAYS instrument (lung cancer version), a self-completed questionaire that obtains data on presenting symptoms and their duration prior to consultation. We will monitor every month during the trial the consultations of trial participants through electronic searches of the GP records. If a consultation has occurred about a respiratory symptom in that timeframe, the participant will be sent a DELAYS questionaire to complete about symptoms relating to that consultation.
Timepoint [2] 301967 0
Monitored for 12 months. If a consultation does occur a "Symptoms questionaire" is sent to the patient.

Eligibility
Key inclusion criteria
Aged 55 and over with at least 20 pack years, including ex-smokers if their cessation date was less than 15 years ago. Read and write English and give informed consent.
Minimum age
55 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Severe psychiatric or cognitive disorder or previous diagnosis of lung cancer.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
258
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 286961 0
University
Name [1] 286961 0
Unversity of Western Australia.
Country [1] 286961 0
Australia
Primary sponsor type
University
Name
University of Western Australia.
Address
Faculty of Medicine, Dentistry and Health Science.
The University of Western Australia,
N Block, QEII Medical Centre,
M706, 35 Stirling Highway, Crawley, WA 6009.
Country
Australia
Secondary sponsor category [1] 285746 0
None
Name [1] 285746 0
Address [1] 285746 0
Country [1] 285746 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289011 0
Human Research Ethics Committee.
Ethics committee address [1] 289011 0
Faculty of Medicine, Dentistry and Health Science.
The University of Western Australia,
N Block, QEII Medical Centre,
M706, 35 Stirling Highway, Crawley, WA 6009.
Ethics committee country [1] 289011 0
Australia
Date submitted for ethics approval [1] 289011 0
27/02/2013
Approval date [1] 289011 0
14/03/2013
Ethics approval number [1] 289011 0
RA/4/16018

Summary
Brief summary
This study is evaluating the effect of an intervention aimed at promoting earlier symptom appraisal and help-seeking for people at higher risk of lung cancer. Who is it for? You may be eligible to join this study if you are aged between 55-90 years and have smoked at least one packet of cigarettes daily for a period of 20 years (i.e. 20 pack years). This includes ex-smokers if your cessation date was less than 15 years ago. Trial details: Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in one group will receive standard care, whilst participants in the other group will be offered the CHEST intervention. This is theoretically based and comprises a 40 minute primary nurse consultation to discuss and implement a self-help manual, followed by monthly self-monitoring reminders by either, email, text message or phone call. Participants will be monitored for 12 months to evaluate the effect of the intervention on consultation rates and time to consultation for chest symptoms.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38802 0
Prof Jon Emery
Address 38802 0
Faculty of Medicine, Dentistry and Health Sciences,
The University of Western Australia,
N Block, QEII Medical Centre,
M706, 35 Stirling Highway,
Crawley WA 6009.
Country 38802 0
Australia
Phone 38802 0
61 8 9346 7508
Fax 38802 0
Email 38802 0
jon.emery@uwa.edu.au
Contact person for public queries
Name 38803 0
Ms Sonya Murray
Address 38803 0
Faculty of Medicine, Dentistry and Health Sciences,
The University of Western Australia,
N Block, QEII Medical Centre,
M706, 35 Stirling Highway,
Crawley WA 6009.
Country 38803 0
Australia
Phone 38803 0
61 8 9346 7237
Fax 38803 0
Email 38803 0
Sonya.Murray@uwa.edu.au
Contact person for scientific queries
Name 38804 0
Prof Jon Emery
Address 38804 0
Faculty of Medicine, Dentistry and Health Sciences,
The University of Western Australia,
N Block, QEII Medical Centre,
M706, 35 Stirling Highway,
Crawley WA 6009.
Country 38804 0
Australia
Phone 38804 0
61 8 9346 7237
Fax 38804 0
Email 38804 0
Sonya.Murray@uwa.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseProtocol for the CHEST Australia trial: A phase II randomised controlled trial of an intervention to reduce time-to-consult with symptoms of lung cancer.2015https://dx.doi.org/10.1136/bmjopen-2015-008046
N.B. These documents automatically identified may not have been verified by the study sponsor.