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Trial registered on ANZCTR


Registration number
ACTRN12617000957392
Ethics application status
Approved
Date submitted
22/06/2017
Date registered
4/07/2017
Date last updated
4/07/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
LEAD - Lung cancer diagnostic and treatment pathways: a comparison between Culturally and Linguistically Diverse (CALD) and Anglo-Australian patients
Scientific title
LEAD - Lung cancer diagnostic and treatment pathways: a comparison between Culturally and Linguistically Diverse (CALD) and Anglo-Australian patients
Secondary ID [1] 292256 0
1100024
This is the ID number allocated by the funding organisation (i.e. Cancer Council Australia)
Universal Trial Number (UTN)
Trial acronym
LEAD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
lung cancer 303770 0
Condition category
Condition code
Public Health 303138 303138 0 0
Health service research
Cancer 303139 303139 0 0
Lung - Non small cell
Cancer 303140 303140 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
The LEAD project has a mixed-method, observational cohort design. The quantitative arm comprises a patient survey, a review of general practice records, and a case-note analysis of hospital records to collect data relevant to the four time intervals. The qualitative arm comprises interviews with lung cancer patients, general practitioners (GPs) and hospital specialists. Data will be collected once only at the time of data collection and the period of observation in each participant will be from the patient noticing symptoms to the commencement of first treatment
Intervention code [1] 298422 0
Not applicable
Comparator / control treatment
The study will compare the differences between CALD and Anglo-Australian patients in the four time intervals along the lung cancer diagnostic and pre-treatment pathway.
Control group
Active

Outcomes
Primary outcome [1] 302514 0
The first primary outcome variable is the length of the appraisal interval along the cancer diagnostic and pre-treatment pathway. The definition and measurement of this interval are guided by the Models of Pathway to Treatment (Walter et al., 2012). This time interval will be estimated using the Kaplan-Meier method and will be compared between the two patient groups using a log-rank test. Data will be collected through the patient survey.
Timepoint [1] 302514 0
Once only at the time of data collection.
Primary outcome [2] 302563 0
The second primary outcome variable is the length of the help-seeking interval along the cancer diagnostic and pre-treatment pathway. The definition and measurement of this interval are guided by the Models of Pathway to Treatment (Walter et al., 2012). This time interval will be estimated using the Kaplan-Meier method and will be compared between the two patient groups using a log-rank test. Data will be collected through the patient survey and the GP review.
Timepoint [2] 302563 0
Once only at the time of data collection.
Primary outcome [3] 302564 0
The third outcome variable is the length of the diagnostic and the pre-treatment intervals along the cancer diagnostic and pre-treatment pathway. The definition and measurement of these intervals are guided by the Models of Pathway to Treatment (Walter et al., 2012). These time intervals will be estimated using the Kaplan-Meier method and will be compared between the two patient groups using a log-rank test. Data will be collected through the GP review and the case-note analysis of hospital medical records.
Timepoint [3] 302564 0
Once only at the time of data collection.
Secondary outcome [1] 336278 0
The first group of secondary outcome is patients' cancer and demographic variables. These include type and staging of cancer, patients' attitudes and beliefs, English proficiency, education levels, etc. Data will be collected through the patient survey, the case-note analysis, and the patient interview.
Timepoint [1] 336278 0
Once only at the time of data collection.
Secondary outcome [2] 336374 0
The second group of secondary outcome is heath care provider related variables. These include GP demographics and billing practices, types of specialists seen, etc. Data will be collected through the GP review, the case-note analysis and interviews with GPs and specialists.
Timepoint [2] 336374 0
Once only at the time of data collection.
Secondary outcome [3] 336375 0
The third group of secondary outcome is health system related variables . These include involvement of a multidisciplinary team, types and places of investigations undertaken, etc.Data will be collected through the case-note analysis and interviews with GPs and specialists.
Timepoint [3] 336375 0
Once only at the time of data collection.

Eligibility
Key inclusion criteria
The patients need to meet two inclusion criterion: (1) be diagnosed with primary lung cancer at the study sites within the past month or during the recruitment phase, and (2) be CALD or Anglo-Australian patients. CALD patients are those who speak one of the following five languages at home or listing these languages as their preferred language: Greek, Italian, Vietnamese, Arabic and Chinese (including Cantonese and Mandarin). Anglo-Australian patients are those (1) being born in Australia or other major English-speaking countries (Canada, New Zealand, the United Kingdom, and the US), and (2) listing English as their preferred language.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are pregnant or aged under 18 years will be excluded.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
Quantitative arm: Data from the patient survey, the GP review and the case-note analysis will be entered into separate databases. For patients who return the survey and provide consent for access to their hospital and general practice medical records, a unique participant ID will be created, which will be used to link data from the three databases. For those who do not provide consent, no data linkage will be performed. The four time intervals will be estimated using the Kaplan-Meier method and will be compared between the two patient groups using a log-rank test. The Cox proportional hazards model will be performed to examine any associations between the time intervals and patient, healthcare provider, and health systems factors. Chi-square tests will be used to compare categorical variables between the two groups. Exploratory analyses may be performed by adjusting for patients’ characteristics using logistic regression. These analyses will be conducted using SPSS 24.
Quantitative arm: All interviews will be audio-taped, and transcription, translation, coding, and analysis will occur concurrently with data collection. Thematic analysis will be conducted using a constant comparative method to identify similarities and differences in the content (Ryan & Bernard, 2003). Data will be analysed inductively and deductively. The interviews will then be incorporated into NVivo ver.10 for more structured coding and analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
15/05/2017
Date of last participant enrolment
Anticipated
31/12/2018
Actual
Date of last data collection
Anticipated
29/03/2019
Actual
Sample size
Target
1064
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 8415 0
The Alfred - Prahran
Recruitment hospital [2] 8416 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [3] 8417 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [4] 8418 0
Sunshine Hospital - St Albans
Recruitment hospital [5] 8419 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [6] 8420 0
Box Hill Hospital - Box Hill
Recruitment hospital [7] 8421 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [8] 8422 0
The Northern Hospital - Epping
Recruitment hospital [9] 8423 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [10] 8424 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 16487 0
3004 - Prahran
Recruitment postcode(s) [2] 16488 0
3168 - Clayton
Recruitment postcode(s) [3] 16489 0
3050 - Parkville
Recruitment postcode(s) [4] 16490 0
3021 - St Albans
Recruitment postcode(s) [5] 16491 0
3000 - Melbourne
Recruitment postcode(s) [6] 16492 0
3128 - Box Hill
Recruitment postcode(s) [7] 16493 0
3084 - Heidelberg
Recruitment postcode(s) [8] 16494 0
3076 - Epping
Recruitment postcode(s) [9] 16495 0
2050 - Camperdown
Recruitment postcode(s) [10] 16496 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 296804 0
Government body
Name [1] 296804 0
Cancer Council Australia
Country [1] 296804 0
Australia
Funding source category [2] 296834 0
Government body
Name [2] 296834 0
Cancer Australia
Country [2] 296834 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Monash University, Victoria 3800, Australia
Country
Australia
Secondary sponsor category [1] 295790 0
None
Name [1] 295790 0
Address [1] 295790 0
Country [1] 295790 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298037 0
Monash Health HREC
Ethics committee address [1] 298037 0
Ethics committee country [1] 298037 0
Australia
Date submitted for ethics approval [1] 298037 0
21/09/2016
Approval date [1] 298037 0
26/10/2016
Ethics approval number [1] 298037 0
HREC/16/MonH/311

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75778 0
Prof Danielle Mazza
Address 75778 0
Department of General Practice
School of Primary and Allied Health Care
Faculty of Medicine, Nursing and Health Sciences
Monash University
Building 1, 270 Ferntree Gully Road
Notting Hill, Vic 3168
Australia
Country 75778 0
Australia
Phone 75778 0
+61 3 9902 4512
Fax 75778 0
+61 3 9902 4300
Email 75778 0
danielle.mazza@monash.edu
Contact person for public queries
Name 75779 0
Xiaoping Lin
Address 75779 0
Department of General Practice
School of Primary and Allied Health Care
Faculty of Medicine, Nursing and Health Sciences
Monash University
Building 1, 270 Ferntree Gully Road
Notting Hill, Vic 3168
Australia
Country 75779 0
Australia
Phone 75779 0
+61 3 9902 4481
Fax 75779 0
+61 3 9902 4300
Email 75779 0
xiaoping.lin@monash.edu
Contact person for scientific queries
Name 75780 0
Xiaoping Lin
Address 75780 0
Department of General Practice
School of Primary and Allied Health Care
Faculty of Medicine, Nursing and Health Sciences
Monash University
Building 1, 270 Ferntree Gully Road
Notting Hill, Vic 3168
Australia
Country 75780 0
Australia
Phone 75780 0
+61 3 9902 4481
Fax 75780 0
+61 3 9902 4300
Email 75780 0
xiaoping.lin@monash.edu

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

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Plain language summaryNo The main outcome paper has been submitted to a pee... [More Details]

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