Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000013662
Ethics application status
Approved
Date submitted
2/12/2022
Date registered
9/01/2023
Date last updated
16/01/2024
Date data sharing statement initially provided
9/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Teletriage study to streamline access to specialist care and clinical trials for melanoma and other skin cancers in regional areas
Scientific title
TRialHub tELetriAge pilot studY: A pilot study to assess the feasibility of a teledermatology triage service to streamline the diagnosis and management of melanoma and keratinocyte cancers, and promote clinical trials participation, for patients presenting with skin lesions of concern in a regional GP clinic
Secondary ID [1] 308516 0
Nil known
Universal Trial Number (UTN)
Trial acronym
RELAY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
melanoma 328339 0
skin cancer 328340 0
Condition category
Condition code
Cancer 325376 325376 0 0
Malignant melanoma
Cancer 325377 325377 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this pilot study, we will use an existing commercially available teledermatology platform to deliver a skin cancer triaging service in Regional Australia, to investigate its impacts on skin cancer referrals and clinical trials participation. Referring GPs at Bendigo Primary Care Centre will upload consenting patients' clinical information and skin lesion photographs onto the teledermatology platform. Photos are taken by the referring GP and estimated to take less than thirty seconds per skin lesion. The Regional Care Navigator (nurse at Bendigo Health) will assess the quality of the photos, and forward these to a dermatologist at Peter MacCallum Cancer Centre. If required, patients will be invited to attend an appointment at Bendigo Health for improved clinical photos taken by the Regional Care Navigator, and are presented with concurrent opportunities to participate in other eligible clinical trials. The dermatologist provides a remote assessment of the preferred diagnosis and recommended management plan, and generates a teledermatology report using the same online platform. Management recommendations include reassurance of benign lesion, interval monitoring, non-surgical intervention such as cryotherapy, surgical intervention including excisional biopsies or referral to a dermatologist face-to-face assessment. Uptake and adherence to intervention will be assessed by audit of electronic medical records at Bendigo Primary Care Centre. At least 100 participants are anticipated to be enrolled over a 6 month period. An electronic modified technology acceptability survey will be used to assess acceptability of this service to patients, RCN, GPs and dermatologists.
Intervention code [1] 324952 0
Early detection / Screening
Intervention code [2] 324953 0
Diagnosis / Prognosis
Comparator / control treatment
Outcomes of the intervention will be compared to data from the same clinic in the 6 months prior to implementation, sourced from medical records recorded in the clinic's practice management software.
Control group
Historical

Outcomes
Primary outcome [1] 333234 0
Proportion of skin cancer referrals sent via the platform compared to data from the same clinic from the previous 6 months. This will be assessed by accessing medical records from the clinic's practice management software and the teledermatology platform.
Timepoint [1] 333234 0
Pre-implementation (from 6 months prior to intervention commencement to the time of intervention commencement) and post-implementation (from the time of intervention commencement to 6 months post-intervention commencement)
Secondary outcome [1] 416282 0
Proportion of teledermatology reports received by Regional Care Navigator within 48 hours after patient visit to general practitioner clinic, by accessing reports within the teledermatology platform
Timepoint [1] 416282 0
Post-implementation (from the time of recruitment of the first patient to 6 months post-recruitment of the first patient).
Secondary outcome [2] 416283 0
Changes in ratio of benign to malignant skin excisions compared to data from the same clinic from the previous 6 months by accessing biopsy results from patient electronic medical records at Bendigo Primary Care Centre and Bendigo Hospital
Timepoint [2] 416283 0
Pre-implementation (from 6 months prior to intervention commencement to the time of intervention commencement) and post-implementation (from the time of intervention commencement to 6 months post-intervention commencement)
Secondary outcome [3] 416284 0
Proportion of biopsy-proven referrals for head and neck skin malignancies compared to data from the same clinic from the previous 6 months by accessing medical records at Bendigo Primary Care Centre
Timepoint [3] 416284 0
Pre-implementation (from 6 months prior to intervention commencement to the time of intervention commencement) and post-implementation (from the time of intervention commencement to 6 months post-intervention commencement)
Secondary outcome [4] 416285 0
Number of participants recruited into clinical trials and cohort studies by the Regional Care Navigator as a composite, assessed by a form completed by the regional care navigator within the REDCap database.
Timepoint [4] 416285 0
Post-implementation (from the time of recruitment of the first patient to 6 months post-recruitment of the first patient).
Secondary outcome [5] 416286 0
Proportion of people appropriately managed in primary care without a hospital visit compared to data from the same clinic from the previous 6 months by accessing data within the patient medical records at Bendigo Primary Care Centre.

Appropriate management is assessed in accordance to Cancer Council Australia clinical practice guidelines for keratinocyte cancer, and Cancer Council Australia clinical practice guidelines for the diagnosis and management of melanoma.
Timepoint [5] 416286 0
Pre-implementation (from 6 months prior to recruitment of the first patient to the time of recruitment of the first patient) and post-implementation (from the time of recruitment of the first patient to 6 months post-recruitment of the first patient).
Secondary outcome [6] 416287 0
Number of unnecessary hospital clinic visits for patients referred for skin cancer management by assessing patient medical records within Bendigo Primary Care Centre and Bendigo Health.
An unnecessary hospital visit is defined as either a visit to a hospital clinic (including dermatology, plastics, general surgery) for a diagnostic biopsy which could have been performed in primary care; or a visit to a hospital clinic which resulted in reassurance for a benign lesion.
Timepoint [6] 416287 0
Pre-implementation (from 6 months prior to recruitment of the first patient to the time of recruitment of the first patient) and post-implementation (from the time of recruitment of the first patient to 6 months post-recruitment of the first patient).
Secondary outcome [7] 416288 0
Time from referral to definitive management compared to data from the same clinic from the previous 6 months. Date of definitive management is defined as date of excision procedure or commencement of appropriate non-surgical management of a malignant lesion, or decision to reassure or monitor in the case of benign lesions compared to routinely collected Bendigo Health administrative data from patients referred from non-participating GP clinics. Outcome will be assessed by accessing patient data from Bendigo Health.
Timepoint [7] 416288 0
Pre-implementation (from 6 months prior to recruitment of the first patient to the time of recruitment of the first patient) and post-implementation (from the time of recruitment of the first patient to 6 months post-recruitment of the first patient).
Secondary outcome [8] 416289 0
Regional Care Navigator's perceptions of acceptability, relevance and comprehensibility of the teledermatology triaging model, assessed via a study-specific modified Technology Acceptability survey instrument, based on similar measures used in previous research
Timepoint [8] 416289 0
6 months post-intervention commencement
Secondary outcome [9] 416662 0
Referring GP's perceptions of acceptability, relevance and comprehensibility of the teledermatology triaging model, assessed via a study-specific modified Technology Acceptability survey instrument, based on similar measures used in previous research.
Timepoint [9] 416662 0
6 months post-intervention commencement
Secondary outcome [10] 416663 0
Dermatologists' perceptions of acceptability, relevance and comprehensibility of the teledermatology triaging model, assessed via a study-specific modified Technology Acceptability survey instrument, based on similar measures used in previous research.
Timepoint [10] 416663 0
6 months post-intervention commencement

Eligibility
Key inclusion criteria
Patients are eligible to be included in the study if they meet ALL of the following criteria:
- Patient must have at least 1 lesion of concern to the patient or to the treating doctor.
- Patient is willing to undergo clinical photography for skin lesion(s) of concern.
- Patient is aged 18 years or older.
- Ability to understand information written in English and capacity to provide informed consent
- Patient must hold a valid Medicare card

Regional care navigator will have performed duties for 6 months from the date of recruitment of the first participant.

The GPs are eligible to participate if they have referred at least 1 patient to the regional care navigator via the teledermatology platform.

The dermatologists are eligible to participate if they have provided teledermatology assessment for at least 1 patient via the teledermatology platform.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patient has a known past or current diagnosis of cognitive impairment.
- Patient is unable to stand for photography.
- Unable to read and complete PICF and/or surveys

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Data collected from pre-implementation (before the recruitment of the first patient) will be compared to data collected post-implementation (from the time of recruitment of the first patient to 6 months post-recruitment of the first patient).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/01/2023
Actual
27/02/2023
Date of last participant enrolment
Anticipated
10/07/2023
Actual
3/10/2023
Date of last data collection
Anticipated
24/07/2023
Actual
23/10/2023
Sample size
Target
100
Accrual to date
Final
51
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 23651 0
Bendigo Health Care Group - Bendigo Hospital - Bendigo
Recruitment postcode(s) [1] 39071 0
3550 - Bendigo

Funding & Sponsors
Funding source category [1] 312755 0
Other Collaborative groups
Name [1] 312755 0
Trialhub -Alfred Hospital
Country [1] 312755 0
Australia
Primary sponsor type
Hospital
Name
Alfred Hospital
Address
55 Commercial Road, Melbourne, VIC 3004
Country
Australia
Secondary sponsor category [1] 314385 0
None
Name [1] 314385 0
Address [1] 314385 0
Country [1] 314385 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312057 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 312057 0
Ethics committee country [1] 312057 0
Australia
Date submitted for ethics approval [1] 312057 0
24/07/2022
Approval date [1] 312057 0
29/09/2022
Ethics approval number [1] 312057 0
88766

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

Contacts
Principal investigator
Name 123306 0
A/Prof Victoria Mar
Address 123306 0
Alfred Health
55 Commercial Road
Melbourne Victoria 3004
Australia
Country 123306 0
Australia
Phone 123306 0
+61 3 9076 9952
Fax 123306 0
Email 123306 0
[email protected]
Contact person for public queries
Name 123307 0
Maithili Sashindranath
Address 123307 0
Monash University, Level 5, 553 St Kilda Road, Melbourne VIC 3004
Country 123307 0
Australia
Phone 123307 0
+61 3 99030155
Fax 123307 0
Email 123307 0
[email protected]
Contact person for scientific queries
Name 123308 0
Maithili Sashindranath
Address 123308 0
Monash University, Level 5, 553 St Kilda Road, Melbourne VIC 3004
Country 123308 0
Australia
Phone 123308 0
+61399030155
Fax 123308 0
Email 123308 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?
Individual participant data of published results
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
lesion analyses using computer generated algorithms
How or where can data be obtained?
access subject to approvals by Principal Investigator (by emailing [email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17729Study protocol    385062-(Uploaded-29-11-2022-16-16-31)-Study-related document.docx
17730Informed consent form    385062-(Uploaded-08-12-2022-11-38-42)-Study-related document.docx
17731Ethical approval    385062-(Uploaded-29-11-2022-16-18-14)-Study-related document.pdf



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.