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Trial registered on ANZCTR


Registration number
ACTRN12616001716459
Ethics application status
Approved
Date submitted
16/11/2016
Date registered
14/12/2016
Date last updated
14/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A research study of digitally supported skin self-examination compared to usual care in people treated for localised melanoma
Scientific title
A pilot randomised controlled trial of digitally supported skin self-examination compared to usual care in people treated for localised melanoma
Secondary ID [1] 290552 0
Nil known
Universal Trial Number (UTN)
Trial acronym
MEL-SELF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 300996 0
Condition category
Condition code
Cancer 300792 300792 0 0
Malignant melanoma
Skin 301083 301083 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants allocated to the intervention will receive:
• An educational booklet ‘Your guide to early melanoma’,
• Web-based ASICA skin checker log-in. The web-based ASICA skin checker combines instructional videos, guided total skin self-examination and electronic reporting,15
• A dermatoscope to attach to their phone similar to that reported in Manahan et al.16.
• Detailed written instructions on how to use the Molescope App and dermatoscope.
• Training on how to use Molescope App and dermatoscope in the form of Face to face training and/or training via live or recorded webinar. Patients may be invited to attend study sites for face to face training and/or offered training by webinar. This training will be conducted by site staff and/or qualified Molescope trainers.
• Email and SMS text reminders every 2 months to perform SSE.
• Teledermoscopy: participants are required to take dermoscopic images of at least 3 lesions and up to 9 lesions on each SSE, including all lesions that concern them, and submit these through the dermatoscope App (Molescope App). They are also required to enter a text description of the results of SSE for each part of the body and submit this through the web-based ASICA skin checker. Both dermoscopic images and text reports will be sent securely to one of the study dermatologists, who will undertake teledermatology review within 3 days and feedback the results to the participant.
• Unscheduled visits as needed in addition to those prompted through Teledermatology.
• Scheduled visits as per treating clinician

All participants will receive three study questionnaires; one at baseline, one at 6 months and at 12 months.
Intervention code [1] 296417 0
Early detection / Screening
Comparator / control treatment
Participants allocated to the control arm will receive:
• An educational booklet ‘Your guide to early melanoma’;
• Unscheduled visits as needed
• Scheduled visits as per treating clinician

All participants will receive three study questionnaires; one at baseline, one at 6 months and at 12 months.
Control group
Active

Outcomes
Primary outcome [1] 300208 0
Proportion of patients who are contacted and randomised into the trial (composite primary outcome)
We will assess this by using the trial management database that will record people invited to participate and those who participate
Timepoint [1] 300208 0
Baseline
Secondary outcome [1] 329369 0
Adherence with the national guidelines recommendations on Skin self examination practice (total body self-examination conducted two- monthly); This will be measure by one question developed for this study asking participants how often they perform a complete examination of their skin.


At baseline 6 and 12 months participants will be ask if they perform skin self-examination every two moth as per the Australian guidelines.
Timepoint [1] 329369 0
Baseline
6 months
12 months
Secondary outcome [2] 329370 0
Level of fear of new or recurrent melanoma (FCR) severity. This outcome will be measured using the Fear of Cancer Recurrence Inventory (FCRI) severity subscale (9 items)
Timepoint [2] 329370 0
Baseline
6 months
12 months
Secondary outcome [3] 329371 0
General anxiety
This outcome will be measured using the short version of the Depression Anxiety and Stress Scales (DASS-21).
Timepoint [3] 329371 0
Baseline
6 months
12 months
Secondary outcome [4] 329372 0
Number of lesions surgically evaluated
This outcome will be assessed by conducting a review of medical records at the clinic.
Timepoint [4] 329372 0
Baseline
6 months
12 months
Secondary outcome [5] 329373 0
Sensitivity of patient performed teledermoscopy for detecting skin lesions that warrant clinical review.
*Index test: teledermatology. A dermatologist who is blinded to clinical diagnosis + histopathology will review the patient performed teledermoscopy + text descriptions and assign skin lesions to the following clinical categories: clinical review warranted vs clinical review not warranted.
*Reference test: Clinician opinion on whether review was warranted. An outcome assessor who is blinded to the teledermatology will review clinical notes +/- histopathology (where available) and assign skin lesions to the following clinical categories: clinical review warranted vs clinical review not warranted.
Timepoint [5] 329373 0
6 months
12 months
Secondary outcome [6] 329374 0
Resource use
we will use a resource use diary. The diary will be used to document and measure health behaviours and service use - such as hospitalisation, other allied health consultations, use of alternative therapies and self-monitoring behaviours. The diary will also document days out-of-role (including paid and unpaid work), travel costs and carer costs.
Timepoint [6] 329374 0
6 months
12 months
Secondary outcome [7] 329601 0
Stress
This outcome will be measured using the short version of the Depression Anxiety and Stress Scales (DASS-21).
Timepoint [7] 329601 0
Baseline
6 months
12 months
Secondary outcome [8] 329602 0
Depression
This outcome will be measured using the short version of the Depression Anxiety and Stress Scales (DASS-21).
Timepoint [8] 329602 0
Baseline
6 months
12 months
Secondary outcome [9] 329603 0
Knowledge of Skin self examination
this will be measured using item developed by Janda et al. (not validated) and adapted for this study.
Timepoint [9] 329603 0
Baseline
6 months
12 months
Secondary outcome [10] 329604 0
Confidence in performing skin self examination
This outcome will be measured using item developed by Janda et al. (not validated) and adapted for this study.
Timepoint [10] 329604 0
Baseline
6 months
12 months
Secondary outcome [11] 329605 0
Thoroughness of performing skin self examination
This outcome will be measured using item developed by Janda et al. (not validated) and adapted for this study.
Timepoint [11] 329605 0
Baseline
6 months
12 months
Secondary outcome [12] 329606 0
Belief about performing skin self examination
This outcome will be measured using item developed by Janda et al. (not validated) and adapted for this study.
Timepoint [12] 329606 0
Baseline
6 months
12 months
Secondary outcome [13] 329607 0
Attitude towards performing skin self examination
This outcome will be measured using item developed by Janda et al. (not validated) and adapted for this study.
Timepoint [13] 329607 0
Baseline
6 months'
12 months

Eligibility
Key inclusion criteria
• Patients treated for stage 0/I/II melanoma who 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);
• Own a Smartphone (and have 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;
• Aged 18+ years old.
Minimum age
18 Years
Maximum age
No limit
Gender
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 own a Smartphone
• 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)
Randomisation will be performed using the offsite randomisation service provided by the NHMRC Clinical Trials Centre, The University of Sydney, thus ensuring allocation concealment. The research coordinator will call the NHMRC Clinical Trials Centre (using their telephone randomisation service) to randomise the patient once a consent form and the baseline questionnaire has been received and eligibility confirmed by the clinician.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Consenting patients who finally meet all inclusion/exclusion criteria will be randomised in a ratio of 1:1 to the intervention or usual care.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Primary outcomes:
The proportion of patients who are randomised into the trial will be estimated using the number of contacted patients as the denominator. The Wilson (score) method will be used to estimate the confidence interval for this proportion to assess the best and worst case scenarios supported by the pilot study data. We will investigate and describe any groups that had low participation rates in our pilot study.
Secondary outcomes:
We will use a chi-squared test to investigate the difference in proportion undertaking regular skin self-examination between the intervention arm and the usual care arm. A t-test will be used to compare fear of new or recurrent melanoma severity at 12 months between the intervention and usual care group. We will report any estimated differences (either proportions or means) with appropriate confidence intervals as the power for these comparisons will be limited.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 6940 0
The Poche Centre, Melanoma Institute Australia - North Sydney
Recruitment hospital [2] 11656 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 14629 0
2060 - North Sydney
Recruitment postcode(s) [2] 14686 0
2290 - Charlestown
Recruitment postcode(s) [3] 23702 0
2050 - Camperdown
Recruitment postcode(s) [4] 23703 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 294987 0
Government body
Name [1] 294987 0
National Health and Medical Research Council (NHMRC)
Address [1] 294987 0
GPO Box 1421
CANBERRA ACT 2601
Country [1] 294987 0
Australia
Funding source category [2] 295039 0
Charities/Societies/Foundations
Name [2] 295039 0
Friends of Mater Foundation
Address [2] 295039 0
Mater Hospital, North Sydney
Rocklands Road
North Sydney NSW 2060
Country [2] 295039 0
Australia
Primary sponsor type
Individual
Name
Dr Catherine Bell
Address
Rm 333 Edward Ford Building A27
Sydney School of Public Health
Sydney Medical School The University of Sydney
NSW 2006
Country
Australia
Secondary sponsor category [1] 293856 0
None
Name [1] 293856 0
Address [1] 293856 0
Country [1] 293856 0
Other collaborator category [1] 280296 0
Other Collaborative groups
Name [1] 280296 0
ANZMTG
Address [1] 280296 0
The Poche Centre
40 Rocklands Road North Sydney NSW 2060
Country [1] 280296 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296341 0
Sydney Local Health District (RPAH zone)
Ethics committee address [1] 296341 0
Missenden Road,
CAMPERDOWN, NSW, 2050
Ethics committee country [1] 296341 0
Australia
Date submitted for ethics approval [1] 296341 0
27/04/2016
Approval date [1] 296341 0
10/05/2016
Ethics approval number [1] 296341 0
X15-0445 & HREC/15/RPAH/593

Summary
Brief summary
The purpose of this pilot study is to evaluate digitally supported skin self-examination compared to usual care in people treated for localised melanoma.

Who is it for?
You may be eligible to join this study if you are aged 18 years or above and have been treated for stage 0/I/II melanoma who are attending regular melanoma follow-ups at the Melanoma Institute Australia (MIA), Royal Prince Alfred Hospital (RPAH) and the Newcastle Skin Check .

Study details
People who are found to be eligible and who consent to participate will be randomised (allocated by chance) to the intervention or usual care in a 1:1 ration. Usual care group will receive an educational booklet on early melanoma and the usual number of routine clinic visits. In addition to usual care, participants allocated to intervention group will download the MoleScope app on to a smartphone and a mobile dermatoscope which they will use to perform total self-examinations every 2 months for 12 months in total along with a web-based ASICA app survey. Email and SMS reminders will also be sent every two months to participants in the intervention group. We will document how well participants are able to perform self-examination, their levels of melanoma-related anxiety, the number of skin lesions biopsied or removed, and the costs of follow-up to the participant and to the healthcare system.
Frequent follow-up of localised melanoma is time and resource intensive, and has not shown improved outcomes. This pilot study will provide evidence on which model is best for follow-up care after treatment for localised melanoma
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70518 0
Dr Catherine Bell
Address 70518 0
Rm 333 Edward Ford Building (A27)
The University of Sydney
NSW 2006
Country 70518 0
Australia
Phone 70518 0
+61415764321
Fax 70518 0
Email 70518 0
katy.bell@sydney.edu.au
Contact person for public queries
Name 70519 0
Miss Yasmin Chu
Address 70519 0
The Poche Centre
40 Rocklands Road North Sydney NSW 2060
Country 70519 0
Australia
Phone 70519 0
+6129911 7294
Fax 70519 0
Email 70519 0
anzmtg02.17@melanoma.org.au
Contact person for scientific queries
Name 70520 0
Dr Catherine Bell
Address 70520 0
Rm 333 Edward Ford Building (A27)
The University of Sydney
NSW 2006
Country 70520 0
Australia
Phone 70520 0
+61415764321
Fax 70520 0
Email 70520 0
katy.bell@sydney.edu.au

No information has been provided regarding IPD availability
Summary results
No Results