Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619000805178
Ethics application status
Approved
Date submitted
27/05/2019
Date registered
3/06/2019
Date last updated
10/12/2019
Date data sharing statement initially provided
3/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Does timely care matter to lung cancer patients? A sub-study of the Continuous Improvement in Care – Cancer (CIC-Cancer) Project.
Scientific title
Does timely care matter to lung cancer patients? A sub-study of the Continuous Improvement in Care – Cancer (CIC-Cancer) Project.
Secondary ID [1] 298343 0
None
Universal Trial Number (UTN)
U1111-1234-1724
Trial acronym
Linked study record
The Continuous Improvement in Care - Cancer (CIC - Cancer) Project.
Principle Investigator: Professor Christobel Saunders, University of Western Australia.

Health condition
Health condition(s) or problem(s) studied:
Lung cancer 312993 0
Condition category
Condition code
Cancer 311498 311498 0 0
Lung - Non small cell
Cancer 311499 311499 0 0
Lung - Small cell

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A cohort of lung cancer patients will be observed from initial abnormal CT scan all the way through until commencing treatment. Various time intervals, including referral - review and referral - treatment will be measured for each patient. At the time of treatment commencement, a patient satisfaction survey will be administered.
Patients will only be followed up until the time of their first treatment.
Intervention code [1] 314586 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320204 0
Patient satisfaction, as measured by the Patient Satisfaction with Cancer Care survey. This is an 18 point survey that was developed and validated in an 891 American cancer patient cohort in 2011 and covers several domains of patient satisfaction, including access to and co-ordination of care and relationships and communication with health professionals.

Reference: Jean-Pierre P, Fiscella K, Freund K et al. Structural and reliability analysis of a patient satisfaction with cancer-related care measure: A multi-site patient navigation research program study. Cancer. 2011; 117(4):854-861.
Timepoint [1] 320204 0
Measured within one week before or after cancer treatment commencement.
Secondary outcome [1] 370859 0
Patient perception of the timeliness of their cancer care.
Patients will be asked: “Do you feel the time from your initial referral to starting treatment has been 1 = Much too quick, 2 = A bit too quick, 3 = Just right, 4 = A bit too slow, 5 = Much too slow.”
Timepoint [1] 370859 0
Measured within one week before or after cancer treatment commencement.

Eligibility
Key inclusion criteria
1) Diagnosis of primary lung cancer
2) Receiving active antineoplastic therapy
3) Reviewed by the Respiratory Service at participating hospitals during the study period
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Patients unable to answer survey questions
2) Patients with mesothelioma.

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Data will be summarised using means (standard deviations) or medians (interquartile ranges) for continuous variables (as appropriate for the distribution) and frequency (percentages) for categorical variables. The relationship between the PSCC and timeliness of care will be considered using appropriate generalised linear models. These relationships will be estimated in isolation and following adjustment for potential confounding factors, including age, medical co-morbidities and performance status.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/06/2019
Actual
11/10/2019
Date of last participant enrolment
Anticipated
15/06/2021
Actual
Date of last data collection
Anticipated
1/07/2021
Actual
Sample size
Target
76
Accrual to date
13
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 13828 0
Royal Perth Hospital - Perth
Recruitment hospital [2] 13829 0
St John of God Midland Public Hospital - Midland
Recruitment postcode(s) [1] 26589 0
6000 - Perth
Recruitment postcode(s) [2] 26590 0
6056 - Midland

Funding & Sponsors
Funding source category [1] 302882 0
Hospital
Name [1] 302882 0
Royal Perth Hospital
Country [1] 302882 0
Australia
Funding source category [2] 302883 0
Hospital
Name [2] 302883 0
St John of God Healthcare Midland Campus
Country [2] 302883 0
Australia
Primary sponsor type
Hospital
Name
Respiratory Department, St John of God Healthcare
Address
St John of God Healthcare Midland Campus
1 Clayton Street
Midland WA 6056
Country
Australia
Secondary sponsor category [1] 302864 0
None
Name [1] 302864 0
Address [1] 302864 0
Country [1] 302864 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303458 0
South Metropolitan Health Service HREC
Ethics committee address [1] 303458 0
Fiona Stanley Hospital
11 Robin Warren Drive
Murdoch WA 6150
Ethics committee country [1] 303458 0
Australia
Date submitted for ethics approval [1] 303458 0
16/05/2019
Approval date [1] 303458 0
21/05/2019
Ethics approval number [1] 303458 0
Ethics committee name [2] 304931 0
St John of God Health Care Human Research Ethics Committee
Ethics committee address [2] 304931 0
St John of God Health Care Midland Campus
1 Clayton Street
Midland WA 6056
Ethics committee country [2] 304931 0
Australia
Date submitted for ethics approval [2] 304931 0
21/07/2019
Approval date [2] 304931 0
02/09/2019
Ethics approval number [2] 304931 0
1578

Summary
Brief summary
Lung cancer is the leading cause of cancer-related mortality and morbidity in Australia, with more than 8000 Australians predicted to die in 2018 alone. Due to the poor outcomes experiences by many lung cancer patients, clinicians attempt to provide rapid review, diagnosis and treatment and adhere to the timeframes suggested in the Cancer Council’s Optimal Care Pathway. Whilst scientific end points, such as survival are important, patient reported outcomes, such as quality of life and satisfaction with care are also vital. This move towards more patient-centric care is being championed in Western Australia by the Continuous Improvement in Care – Cancer (CIC-Cancer) Project.


Are you eligible to take part in this study?

This study aims to establish if providing guideline-driven care, in terms of timeliness, improves patient satisfaction amongst people with lung cancer. You may be eligible to take part if you have primary lung cancer and are undergoing treatment and have consented to have your clinical information collected by the CIC-Cancer database.


What does the study involve?

Patients will be asked to complete an 18 question survey at the time that they start treatment for lung cancer. The survey will assess different areas of patient satisfaction with care, including access to appointments and communication with their doctor. Patients will not be obliged to any other follow up.


How will involvement in this study help patients with lung cancer?

This study will help us to validate the Cancer Council Optimal Care Pathway and ensure that striving to achieve rapid review and treatment really is making patients more satisfied with their care.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93726 0
Dr Phoebe Brownell
Address 93726 0
St John of God Healthcare Midland Campus
1 Clayton Street
Midland WA 6056
Country 93726 0
Australia
Phone 93726 0
+61 411618742
Fax 93726 0
Email 93726 0
[email protected]
Contact person for public queries
Name 93727 0
Dr Phoebe Brownell
Address 93727 0
St John of God Healthcare Midland Campus
1 Clayton Street
Midland WA 6056
Country 93727 0
Australia
Phone 93727 0
+61 411618742
Fax 93727 0
Email 93727 0
[email protected]
Contact person for scientific queries
Name 93728 0
Dr Phoebe Brownell
Address 93728 0
St John of God Healthcare Midland Campus
1 Clayton Street
Midland WA 6056
Country 93728 0
Australia
Phone 93728 0
+61 411618742
Fax 93728 0
Email 93728 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Only responses to the PSCC survey will be shared.
All other patient information is at the discretion of the CIC-Cancer database.
When will data be available (start and end dates)?
Starting at the end of data collection.
Data will be available for 7 years.
Available to whom?
Anyone who wishes to access.
Available for what types of analyses?
Any type of analysis.
How or where can data be obtained?
By approval from the Principle Investigator.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2198Study protocol    377667-(Uploaded-27-05-2019-22-54-39)-Study-related document.docx



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.