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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03581188




Registration number
NCT03581188
Ethics application status
Date submitted
18/06/2018
Date registered
10/07/2018

Titles & IDs
Public title
Patient-led Surveillance Compared to Clinician-led Surveillance in People Treated for Localised Melanoma.
Scientific title
A Randomised Controlled Pilot Trial of Patient-led Surveillance Compared to Clinician-led Surveillance in People Treated for Localised Melanoma.
Secondary ID [1] 0 0
ACTRN12616001716459
Secondary ID [2] 0 0
ANZMTG 02.17
Universal Trial Number (UTN)
Trial acronym
MEL-SELF
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Patient-led surveillance
BEHAVIORAL - Clinician-led surveillance

Experimental: Patient-led surveillance - Participants receive a mobile dermatoscope that attaches to their smartphone to take photos of skin lesions for teledermatology, instructions on skin self-examination from the ASICA skin checker App, text and email reminders to perform self-examination every 2 months, an educational booklet 'Your guide to early melanoma', and scheduled visits to their clinician as required.

Active comparator: Clinician-led surveillance - Participants receive an educational booklet 'Your guide to early melanoma' and scheduled visits to their clinician as required.


Treatment: Devices: Patient-led surveillance
Usual care plus reminders, ASICA instructional videos, a mobile dermatoscope, an app that facilitates store-and-forward teledermatology, and fast-tracked unscheduled clinic visits.

BEHAVIORAL: Clinician-led surveillance
Usual care (scheduled clinician visits)
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The Percentage of Eligible and Contacted Patients Who Were Randomised Into the Trial
Timepoint [1] 0 0
Baseline
Secondary outcome [1] 0 0
Adherence to Recommended Total Body Skin Self Examinations Practice: Frequency of Skin Self-examinations.
Timepoint [1] 0 0
Baseline, at 6 months
Secondary outcome [2] 0 0
Adherence to Recommended Total Body Skin Self Examinations Practice: Thoroughness of Skin Self-examination
Timepoint [2] 0 0
Baseline, 6 months
Secondary outcome [3] 0 0
Successful Submission of Dermoscopic Images for Teledermatology (Intervention Group Only)
Timepoint [3] 0 0
At 6 months
Secondary outcome [4] 0 0
Number of Skin Clinic Visits Attended (Scheduled and Unscheduled)
Timepoint [4] 0 0
During the 12 months after randomisation
Secondary outcome [5] 0 0
Number of Skin Lesions Surgically Excised
Timepoint [5] 0 0
During the 12 months after randomisation
Secondary outcome [6] 0 0
New Subsequent Primary or Recurrent Melanoma Diagnoses
Timepoint [6] 0 0
12 months
Secondary outcome [7] 0 0
New Melanoma Diagnoses Prompted by Visit Type
Timepoint [7] 0 0
During 12 months after randomisation
Secondary outcome [8] 0 0
General Anxiety, Stress, and Depression Measured Using the Depression Anxiety Stress Scales-21
Timepoint [8] 0 0
Baseline, 6 months

Eligibility
Key inclusion criteria
* Patients treated for stage 0/I/II melanoma and are attending regular melanoma follow-up as indicated by scheduled visit within next 12 months in clinic patient booking system and
* Are able to self-examine;
* Have a suitable study partner (spouse, partner, family member, friend);
* Have a smart phone with access to Wifi / email / SMS text messaging;
* Are able to give informed consent ;
* Have sufficient English language skills to read the materials and complete the questionnaires;
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Unable to perform self-examination
* No partner or friend to help with self-examination
* Do not have access to a smart phone with Wifi/email/SMS text messaging
* With a known past or current diagnosis of cognitive impairment

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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/02/2020
Sample size
Target
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Newcastle Skin Check - Newcastle
Recruitment hospital [2] 0 0
Melanoma Institute Australia - North Sydney
Recruitment hospital [3] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2290 - Newcastle
Recruitment postcode(s) [2] 0 0
2060 - North Sydney
Recruitment postcode(s) [3] 0 0
2050 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Melanoma and Skin Cancer Trials Limited
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Katy Bell, A/Prof
Address 0 0
University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03581188