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Trial registered on ANZCTR


Registration number
ACTRN12617000281392
Ethics application status
Approved
Date submitted
11/02/2017
Date registered
23/02/2017
Date last updated
25/05/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Talking with your doctor about diagnosis and treatment for melanoma
Scientific title
Effects of melanoma patient socioeconomic status on communication during Initial consultations
Secondary ID [1] 291161 0
MIA2014/134
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 302024 0
Condition category
Condition code
Cancer 301664 301664 0 0
Malignant melanoma

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Following consent from clinicians and patients, melanoma specialists will audio record the interactions during the initial consultation with new patients. Just the initial consultation will be recorded. Patients will be grouped by socioeconomic status, based on their occupation and level of education.

The recordings will be transcribed and analysed, with the focus on meaning rather than on accent, grammar or vocabulary. Features such as the phrasing of questions, control of turn-taking, clinicians’ responses to patient responses, expressions of degrees of probability and obligation (‘might’, ‘must’, ‘possibly’, ‘definitely’, ‘have to’, ‘I think …’), and the coding of logical relations (such as causality, consequence, conditionality) through conjunctions, abstract nouns and even verbs will also be analysed. These factors influence discussions of treatment outcome and prognosis and may be a frequent source of confusion for patients and families.
Intervention code [1] 297156 0
Not applicable
Comparator / control treatment
All patients will be grouped by socioeconomic (SES) status, based on their occupation, marital status, post code and level of education. The grouping will be undertaken after the clinic appointment that is recorded. To form contrasted SES groups, we are using the criterion of ‘relative autonomy in an occupation to make decisions affecting others in the workplace’ plus level of formal education. The ‘ relative autonomy’ criterion has been used successfully in previous linguistic studies of SES-associated variation in the exchange of meanings, e.g. Ruqaiya Hasan’s research (Hasan, R. Semantic variation (Equinox)) and research by the co-PI, Geoff Williams (Joint book reading and literacy pedagogy: A socio-semantic examination. PhD, Macquarie University, 1995). Because the degree of autonomy is relative and the range of occupations is enormous we do not use formalised cut-offs but instead attempt to maximise the contrast within the group of consenting patients within a reasonable time frame (approximately two months). For example, we would include a lawyer but not a law clerk in the higher-SES group, and similarly a shop assistant but not a shop owner in the lower-SES group. Level of formal education is used to check that there has been no voluntary take-up of an occupation for which a person is ‘over-qualified’, such as a person with a law degree working as a council gardener. Only patients with education up to the end of secondary school are included in the lower-SES group, and only patients with tertiary education (from diploma up) are included in the higher-SES group.Patients will also be grouped within the SES by gender.

Comparative analyses will be performed between upper and lower SES groups and between male and female patients within each SES group.

No validated tools will be used but the analytic framework is derived from systemic functional linguistics (Halliday, 1978; Halliday and Matthiessen, 2013), which is an approach that is widely used internationally for discourse analysis in institutional contexts, including in healthcare contexts such as interaction in accident and emergency departments and during patient handover (Eggins and Slade, 2013; Slade et al., 2008). It has also been used for research into the type of language variation that is comparable to this project, i.e. variation concerned with the exchange of meaning and associated with speakers’ social background (e.g. Cloran, 1989; Hasan, 2009; Williams, 2005).
Control group
Active

Outcomes
Primary outcome [1] 301056 0
Variation in linguistic communication between clinicians and patients by SES status and gender, Including the phrasing of questions, the control of 'turn taking' and expression of degrees of probability.

Audiorecordings will be checked for audibility, and an initial description of the main phases of the interaction will be produced. Once it has been established that recordings are audible and comprehensive (i.e. the full clinical session has been recorded), they will be transcribed literally in preparation for linguistic analysis.

Once transcribed, the clinical interaction will be analysed in two ways. The first involves description of the typical staging of the consultation (stages such as the introduction, taking of the patient’s history, physical examination, explanations, and so on). This step will enable us to identify any major, systematic variation in the structure of consultations between specialisations, and within specialisations, between the SES and gender sub-groups. The second involves analysis of relevant features of the language itself (such as the types of questions, the linguistic patterning of medical explanations, and so on. These will be described using an explicit linguistic methodology, semantic network analysis, which describes features of the language at the clause level through each consultation. The explicitness of the methodology displaces any need for impressionistic coding, so ‘blinding’ is not required.

The analytic framework is derived from systemic functional linguistics (Halliday, 1978; Halliday and Matthiessen, 2013), which is an approach that is widely used internationally for discourse analysis in institutional contexts, including in healthcare contexts such as interaction in accident and emergency departments and during patient handover (Eggins and Slade, 2013; Slade et al., 2008). It has also been used for research into the type of language variation that is comparable to this project, i.e. variation concerned with the exchange of meaning and associated with speakers’ social background (e.g. Cloran, 1989; Hasan, 2009; Williams, 2005).
Timepoint [1] 301056 0
During the clinic appointment
Secondary outcome [1] 331612 0
Identification of any systematic variation in the meanings exchanged during clinical consultations as a function of SES, patient gender, or gender within SES groups.

Once it has been established that recordings are audible and comprehensive (i.e. the full clinical session has been recorded), they will be transcribed literally in preparation for linguistic analysis by the research team, who will be blinded to SES group and clinician name.

The analytic framework is derived from systemic functional linguistics (Halliday, 1978; Halliday and Matthiessen, 2013), which is an approach that is widely used internationally for discourse analysis in institutional contexts, including in healthcare contexts such as interaction in accident and emergency departments and during patient handover (Eggins and Slade, 2013; Slade et al., 2008). It has also been used for research into the type of language variation that is comparable to this project, i.e. variation concerned with the exchange of meaning and associated with speakers’ social background (e.g. Cloran, 1989; Hasan, 2009; Williams, 2005).
Timepoint [1] 331612 0
During the clinic appointment
Secondary outcome [2] 331613 0
The particular features of linguistic meaning which are implicated in any detected variation, and the inter-relationships between the features interpersonal and logical language features.

Once it has been established that recordings are audible and comprehensive (i.e. the full clinical session has been recorded), they will be transcribed literally in preparation for linguistic analysis by the research team, who will be blinded to SES group and clinician name.
Timepoint [2] 331613 0
During the clinic appointment

Eligibility
Key inclusion criteria
All new patients with a diagnosis of melanoma who are attending their first consultation with medical, radiation or surgical oncologists and nurses.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients unable to speak and understand English

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The analytic framework is derived from systemic functional linguistics (Halliday, 1978; Halliday and Matthiessen, 2013), which is an approach that is widely used internationally for discourse analysis in institutional contexts, including in healthcare contexts such as interaction in accident and emergency departments and during patient handover (Eggins and Slade, 2013; Slade et al., 2008). It has also been used for research into the type of language variation that is comparable to this project, i.e. variation concerned with the exchange of meaning and associated with speakers’ social background (e.g. Cloran, 1989; Hasan, 2009; Williams, 2005). For this project a key advantage of the framework is that the analyses will yield data across multiple ‘domains’ of meaning such as topic introduction, maintenance and change; construction of clinician and patient ‘agency’; strategies for logical development of the information; and interpersonal meanings such as foci of clinician and patient questions, the nature and extent of patient narration, clinicians’ expressions of empathy and the pacing of interaction.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
20/05/2016
Date of last participant enrolment
Anticipated
1/11/2018
Actual
Date of last data collection
Anticipated
30/11/2018
Actual
Sample size
Target
16
Accrual to date
8
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 7466 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 7467 0
The Poche Centre, Melanoma Institute Australia - North Sydney
Recruitment postcode(s) [1] 15293 0
2050 - Camperdown
Recruitment postcode(s) [2] 15294 0
2060 - North Sydney
Recruitment postcode(s) [3] 15295 0
2050 - Missenden Road
Recruitment postcode(s) [4] 15296 0
2065 - Wollstonecraft

Funding & Sponsors
Funding source category [1] 295599 0
Charities/Societies/Foundations
Name [1] 295599 0
Friends of the Mater Foundation
Country [1] 295599 0
Australia
Funding source category [2] 295706 0
Charities/Societies/Foundations
Name [2] 295706 0
Melanoma Institute Australia
Country [2] 295706 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Melanoma Institute Australia
Address
40 Rocklands Road
Wollstonecraft NSW 2065
Country
Australia
Secondary sponsor category [1] 294431 0
None
Name [1] 294431 0
Address [1] 294431 0
Country [1] 294431 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296919 0
Sydney Local Health District Ethics Review Committee (Royal Prince Alfred Hospital Zone)
Ethics committee address [1] 296919 0
Ethics committee country [1] 296919 0
Australia
Date submitted for ethics approval [1] 296919 0
Approval date [1] 296919 0
01/02/2015
Ethics approval number [1] 296919 0
X14-0397

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

Contacts
Principal investigator
Name 72434 0
Prof Frances Boyle
Address 72434 0
The Patricia Ritchie Centre for Cancer Care
13 Gillies Street,
Crows Nest, NSW, 2065
Country 72434 0
Australia
Phone 72434 0
+61 2 9957 7744
Fax 72434 0
Email 72434 0
frances.boyle@sydney.edu.au
Contact person for public queries
Name 72435 0
Geoffrey Williams
Address 72435 0
Faculty of Education and Social Work
The University of Sydney
NSW 2006
Country 72435 0
Australia
Phone 72435 0
+61 2 9351 4710
Fax 72435 0
Email 72435 0
geoff.williams@sydney.edu.au
Contact person for scientific queries
Name 72436 0
Teagan McGuigan
Address 72436 0
Melanoma Institute Australia
40 Rocklands Road
Wollstonecraft NSW 2065
Country 72436 0
Australia
Phone 72436 0
+61 2 9911 7384
Fax 72436 0
Email 72436 0
Teagan.McGuigan@melanoma.org.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

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Documents added automatically
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