ANZCTR - Registration

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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

28/04/2020

Date data sharing statement initially provided

28/04/2020

Date results information initially provided

28/04/2020

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]

Nil known

Universal Trial Number (UTN)

Trial acronym

MEL-SELF

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Melanoma

Condition category

Condition code

Cancer

Malignant melanoma

Skin

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]

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]

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]

Baseline

Secondary outcome [1]

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 and 6 months participants will be ask if they perform skin self-examination every two moth as per the Australian guidelines.

Timepoint [1]

Baseline 6 months

Secondary outcome [2]

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]

Baseline 6 months

Secondary outcome [3]

General anxiety
This outcome will be measured using the short version of the Depression Anxiety and Stress Scales (DASS-21).

Timepoint [3]

Before recruitment commenced the trial was shortened to 6 months.

Secondary outcome [4]

Number of lesions surgically evaluated
This outcome will be assessed by conducting a review of medical records at the clinic.

Timepoint [4]

Baseline 6 months

Secondary outcome [5]

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]

6 months

Secondary outcome [6]

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]

6 months

Secondary outcome [7]

Stress
This outcome will be measured using the short version of the Depression Anxiety and Stress Scales (DASS-21).

Timepoint [7]

Baseline 6 months

Secondary outcome [8]

Depression
This outcome will be measured using the short version of the Depression Anxiety and Stress Scales (DASS-21).

Timepoint [8]

Baseline 6 months

Secondary outcome [9]

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]

Baseline 6 months

Secondary outcome [10]

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]

Baseline 6 months

Secondary outcome [11]

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]

Baseline 6 months

Secondary outcome [12]

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]

Baseline 6 months

Secondary outcome [13]

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]

Baseline 6 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

Sex

Both males and females

Can healthy volunteers participate?

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

Completed

Date of first participant enrolment

Anticipated

20/08/2018

Actual

12/11/2018

Date of last participant enrolment

Anticipated

3/09/2018

Actual

24/05/2019

Date of last data collection

Anticipated

3/09/2019

Actual

17/02/2020

Sample size

Target

100

Accrual to date

Final

100

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

The Poche Centre, Melanoma Institute Australia - North Sydney

Recruitment hospital [2]

Royal Prince Alfred Hospital - Camperdown

Recruitment postcode(s) [1]

2060 - North Sydney

Recruitment postcode(s) [2]

2290 - Charlestown

Recruitment postcode(s) [3]

2050 - Camperdown

Recruitment postcode(s) [4]

2050 - Camperdown

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council (NHMRC)

Address [1]

GPO Box 1421
CANBERRA ACT 2601

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Friends of Mater Foundation

Address [2]

Mater Hospital, North Sydney
Rocklands Road
North Sydney NSW 2060

Country [2]

Australia

Primary sponsor type

Individual

Name

Dr Catherine Bell

Address

Rm 131 Edward Ford Building A27
Sydney School of Public Health
Sydney Medical School The University of Sydney
NSW 2006

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Other Collaborative groups

Name [1]

MASC

Address [1]

The Poche Centre
40 Rocklands Road North Sydney NSW 2060

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney Local Health District (RPAH zone)

Ethics committee address [1]

Missenden Road,
CAMPERDOWN, NSW, 2050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

27/04/2016

Approval date [1]

10/05/2016

Ethics approval number [1]

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

A/Prof Catherine Bell

Address

Rm 131 Edward Ford Building (A27) The University of Sydney NSW 2006

Country

Australia

Phone

+61415764321

Fax

[email protected]

Contact person for public queries

Name

A/Prof Catherine Bell

Address

Rm 131 Edward Ford Building (A27) The University of Sydney NSW 2006

Country

Australia

Phone

+61415764321

Fax

[email protected]

Contact person for scientific queries

Name

A/Prof Catherine Bell

Address

Rm 131 Edward Ford Building (A27) The University of Sydney NSW 2006

Country

Australia

Phone

+61415764321

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Confidentiality and privacy - this was not part of inital consent

What supporting documents are/will be available?

Doc. No.	Type	Attachment
7804	Study protocol	371865-(Uploaded-17-03-2020-13-12-57)-Study-related document.doc
7805	Statistical analysis plan	371865-(Uploaded-17-03-2020-13-16-33)-Study-related document.docx
7806	Informed consent form	371865-(Uploaded-17-03-2020-13-13-58)-Study-related document.docx
7807	Ethical approval	371865-(Uploaded-17-03-2020-13-15-44)-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

Source	Title	Year of Publication	DOI
Embase	Exploring the Integration of Environmental Impacts in the Cost Analysis of the Pilot MEL-SELF Trial of Patient-Led Melanoma Surveillance.	2023	https://dx.doi.org/10.1007/s40258-022-00765-6
Embase	Assessing the Potential for Patient-led Surveillance after Treatment of Localized Melanoma (MEL-SELF): A Pilot Randomized Clinical Trial.	2022	https://dx.doi.org/10.1001/jamadermatol.2021.4704

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically