A Randomised Controlled Pilot Trial of Patient-led Surveillance Compared to Clinician-led Surveillance in People Treated for Localised Melanoma.
Phase: NA
Conditions: Melanoma (Skin)
Sponsor: University of Sydney

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02.17 MEL-SELF 
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A pilot randomised controlled trial of patient-led 
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surveillance compared to clinician-led surveillance in 
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people treated for localised melanoma 
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Registration number: ACTRN12616001716459 
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Version 6.0 dated 22 May 2020 
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Principal Investigator:                  Associate Professor Katy Bell 
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Address and contact details:       Sydney School of Public Health | Sydney Medical School 
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      Room 131 Edward Ford Building A27 
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      Mobile: +61 415764321  
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      Email: katy.bell@sydney.edu.au 
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_________________          22 May 2020 
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 Signature 
 
 
Date 
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For information related to the Trial Management Committee membership please refer to the 
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Operations Manual. This is an independent investigator initiated co-operative group trial. 
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Administration  
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Sponsor:  
 
 
The University of Sydney  
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Collaborative/Coordinating  Melanoma and Skin Cancer Trials  
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Group:  
 
 
MASC Trials 
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The Poche Centre 
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40 Rocklands Road 
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North Sydney NSW 2060 Australia 
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Telephone: +61 2 9911 7294 
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Fax: +61 2 9954 9435 
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Email: anzmtg0217@melanoma.org.au 
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Document Version History  
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Version 
Version date 
Main Changes 
2.0 
30/08/2017 
Initial protocol  
3.0 
23/04/2018 
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ANZMTG added as lead collaborative group/co-ordinating 
centre 
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ASICA smartphone App replaced with web-based version 
of the ASICA skin checker App 
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Duration of treatment/study updated 
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Schedule of assessments: Time and Events table added 
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SMS text added as a patient reminder option 
4.0 
24/01/2019 
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Australia and New Zealand Melanoma Trials Group 
(ANZMTG) is now known as Melanoma and Skin Cancer 
Trials Ltd. (MASC Trials). MASC Trials is now the lead 
collaborative group and co-ordinating centre 
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Recruitment process updated for in clinic recruitment and 
not a bulk mail out 
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Baseline questionnaires will be a part of the study 
invitation package 
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Teledermatologist case review recommendations have 
been updated 
 
5.0 
3/12/2019 
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Confidentiality section: Data is stored at University of 
Sydney 
6.0 
22/05/2020 
 
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8.6.2 End of Study updated from 6 months to 12 months 
  
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1. Contents 
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1. 
Contents ...................................................................................................................................................... 4 
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2. 
Abbreviations: .............................................................................................................................................. 6 
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3. 
Study synopsis ............................................................................................................................................ 7 
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Project Team Roles and Responsibilities .................................................................................................... 8 
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5. 
Introduction and rationale ............................................................................................................................ 8 
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5.1. 
Background ......................................................................................................................................... 8 
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5.2. 
Justification/ Significance .................................................................................................................... 9 
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5.3. 
Lay summary ...................................................................................................................................... 9 
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6. 
Study design ................................................................................................................................................ 9 
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6.1. 
Research question(s)/ aim(s): ............................................................................................................. 9 
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6.2. 
Study design ..................................................................................................................................... 10 
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7. 
Study population ........................................................................................................................................ 10 
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7.1. 
Inclusion Criteria ............................................................................................................................... 10 
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7.2. 
Exclusion Criteria .............................................................................................................................. 10 
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8. 
Study procedures ...................................................................................................................................... 11 
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8.1. 
Enrolment procedure ........................................................................................................................ 11 
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8.2. 
Stratification and Randomisation ...................................................................................................... 11 
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8.3. 
Interventions/ Groups ....................................................................................................................... 11 
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8.4. 
Blinding ............................................................................................................................................. 12 
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8.5. 
Duration of treatment/ Study ............................................................................................................. 12 
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8.6. 
Assessment schedule and follow up ................................................................................................ 12 
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8.6.1. 
Follow-up questionnaire (T1): 6 months ....................................................................................... 13 
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8.6.2. 
End of study. ................................................................................................................................. 13 
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8.6.3. 
Withdrawal and Lost to Follow up ................................................................................................. 13 
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Data Collection .......................................................................................................................................... 13 
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Intervention ........................................................................................................................................... 14 
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10.1. 
Intervention and comparison arms ................................................................................................... 14 
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10.2. 
Intervention/ treatment modification ................................................................................................. 15 
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10.3. 
Distribution, packaging and labelling ................................................................................................ 15 
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10.4. 
Accountability for intervention ........................................................................................................... 15 
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Safety Reporting ................................................................................................................................... 15 
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11.1. 
Adverse Events ................................................................................................................................. 15 
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11.2. 
Serious Adverse Events ................................................................................................................... 15 
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Outcomes/ Measures ............................................................................................................................ 16 
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12.1. 
Primary outcome ............................................................................................................................... 16 
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12.2. 
Secondary outcomes ........................................................................................................................ 16 
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12.3. 
Potential confounders and biases .................................................................................................... 17 
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Statistical methods ................................................................................................................................ 17 
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13.1. 
Sample size and justification ............................................................................................................ 17 
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13.2. 
Feasibility .......................................................................................................................................... 17 
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13.3. 
Early stopping ................................................................................................................................... 18 
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13.4. 
Analyses plan ................................................................................................................................... 18 
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13.4.1. 
Statistical analysis for primary endpoint ................................................................................... 18 
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13.4.2. 
Statistical analysis for secondary endpoints ............................................................................. 18 
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13.5. 
Secondary analyses ......................................................................................................................... 18 
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13.6. 
Missing data ...................................................................................................................................... 19 
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13.7. 
Deviations from original statistical plan ............................................................................................ 19 
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Responsibilities of the Principal Investigator at each site ..................................................................... 20 
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Reporting of Results ............................................................................................................................. 20 
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Quality Assurance ................................................................................................................................. 21 
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16.1. 
Data Management and Source Data Verification ............................................................................. 21 
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16.2. 
Protocol Amendments ...................................................................................................................... 21 
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16.3. 
On Site Monitoring ............................................................................................................................ 21 
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16.4. 
Site Audits ......................................................................................................................................... 21 
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16.5. 
Confidentiality ................................................................................................................................... 21 
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References............................................................................................................................................ 21 
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Appendices ........................................................................................................................................... 22 
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2. Abbreviations:  
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AE 
Adverse event 
AJCC 
American Joint Committee of Cancer  
ANZMTG 
Australia and New Zealand Melanoma Trials Group 
App 
Smartphone Application  
ASICA 
Achieving Self-Directed Integrated Cancer Aftercare 
CI 
Co-investigators 
CR 
Complete response 
CRF 
Case report form 
CTCAE 
Common terminology criteria for adverse events 
DASS-21 
Depression Anxiety and Stress Scales 
DSMC 
Data Safety Monitoring Committee 
FCR 
Fear of Cancer Recurrence  
FCRI 
Fear of Cancer Recurrence inventory 
FDA 
Food & Drug Administration 
GCP 
Good Clinical Practice 
GP  
General Practitioner  
HREC 
Human research ethics committees 
ICF 
Informed consent form 
ICH GCP 
International Conference on Harmonisation of Good Clinical Practice 
ID 
Identification 
IELab 
Australian Industrial Ecology Virtual Laboratory 
Kg 
Kilogram 
M 
Million 
MASC Trials  
Melanoma and Skin Cancer Trials Ltd.  
MM 
Millimetre  
MIA  
Melanoma Institute Australia 
NMSC 
Non-Melanoma Skin Cancers  
RCT  
Randomised Controlled Trial  
SEIFA 
Socio-Economic Indexes for Areas  
SSE  
Skin Self-examination  
TMC 
Trial Management Centre 
USYD 
University of Sydney 
 
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3. Study synopsis 
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Title:  
A pilot randomised controlled trial of patient-led surveillance 
compared to clinician-led surveillance in people treated for 
localised melanoma 
Study Number: 
02.17 MEL-SELF  
Primary Objective: 
1. To assess the feasibility of patient-led surveillance. 
Rationale: 
Most new (and recurrent melanomas) are detected by patients 
or family members in between scheduled visits, and this might 
be increased with additional training and support for patient skin 
self-examination and with Teledermatology assessment of 
patient-detected abnormalities. This may enable less frequent 
scheduled follow-up with melanoma clinicians. Fewer scheduled 
visits may be just as safe, cause less anxiety and consume 
fewer resources. 
Study Design: 
Randomised Controlled Trial (RCT) 
Sample Size (by 
treatment group): 
50 participants allocated to the intervention group and 50 
participants allocated to the usual care group 
Study Arms 
(Intervention and 
Control): 
Intervention group:  
(i) Patient-led surveillance: web-based questionnaire based on 
the ASICA skin checker App (with instructional videos and 
electronic reporting of lesions discovered on skin self-
examination), Smartphone App for participants to perform 
teledermoscopy with feedback to participants of Dermatologist 
report, email/SMS reminders to perform total skin self-
examination every 2 months;  
(ii) An educational booklet. 
(iii) Usual scheduled follow-up; 
(iv) Unscheduled visits as needed 
 
Control group:  
(i) an educational booklet  
(ii) Usual scheduled follow-up ;  
(iii) Unscheduled visits as needed 
Study Population 
Adult patients who are undergoing routine melanoma skin 
cancer surveillance. 
Study Endpoints 
(Primary and 
Secondary): 
1. Primary outcome: Proportion of patients who are 
contacted and invited to participate, who are finally 
randomised in the trial. 
 
2. Secondary outcomes: Adherence with recommended 
skin self-examination practice (total body self-
examination conducted two- monthly), thoroughness, 
confidence, knowledge attitudes and beliefs about skin 
self-examination, fear of new or recurrent melanoma, 
general anxiety, stress and depression, number of 
lesions surgically excised, number of follow up visits 
attended (both scheduled and unscheduled), inter-
dermatologist reliability of teledermoscopy, resource use 
and costs (both financial and carbon emission costs), 
and results from the qualitative sub-study.  
 
 

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4. Project Team Roles and Responsibilities 
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Study Chair:  
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Dr Katy Bell, Senior Lecturer in Clinical Epidemiology, Public Health, School of Public Health, The 
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University of Sydney. 
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Protocol Development Group: 
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Professor Monica Janda (academic health psychologist) 
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Associate Professor Anne Cust (cancer epidemiologist) 
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Associate Professor Robin Turner (statistician) 
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Professor Les Irwig (clinical epidemiologist) 
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Associate Professor Pascale Guitera (academic dermatologist) 
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Associate Professor Robyn Saw (melanoma surgeon) 
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Associate Professor Victoria Mar (academic dermatologist) 
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Professor Peter Soyer (academic dermatologist) 
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Dr Mbathio Dieng (epidemiologist & health economist) 
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Dr Jolyn Hersch (academic health psychologist) 
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Associate Professor Rachael Morton (melanoma health economist) 
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Mr Donald Low (consumer investigator) 
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Ms Cynthia Low (consumer investigator) 
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Ms Amelia Smit (public health researcher) 
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Ms Mai Nguyen (health economist) 
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5. Introduction and rationale 
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5.1. Background 
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The increasing incidence of melanoma in Australia (500% increase from 3,526 new melanomas in 
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1982 to 17,570 by 2020)1 is largely driven by increased early detection of localised melanoma 
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before it has spread from the skin2. After treatment, these patients are at risk of developing a 
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recurrent or new primary melanoma and/or NMSCs and are recommended to undergo lifelong 
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follow-up at intervals based on stage that range between 3 to 12 months3. However, they have a 
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very good prognosis in terms of life expectancy: the same as the general population for melanoma 
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in situ (stage 0), and 96% 20 year survival for thin melanomas (<1 mm) (together these are >80% 
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of all localised melanomas4). The potential benefits of clinician surveillance for recurrent or new 
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primary melanoma and NMSC in ensuring timely treatment, needs to be balanced against costs 
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and possible physical and psycho-social harms of frequent scheduled follow-up clinic visits and 
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investigations 5,6. The costs of follow-up are substantial and have been estimated at AU$44M over 
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5 years for American Joint Committee of Cancer (AJCC) stage I/II7. There are also opportunity 
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costs in terms of clinician time, with waiting lists for new patients in public dermatology clinics 
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potentially getting longer. Fewer scheduled follow-up visits may have little impact on the detection 
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of recurrence and new primaries8 and can result in substantial cost savings9. Clinicians are more 
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likely to choose this option if they are confident in the patient’s ability to do their own surveillance 
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through skin self-examination (SSE) 10.                                                                                                                    
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Currently there is no evidence that frequent scheduled follow-up has any effect on patient 
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survival11. In contrast, there is evidence that self-detection of recurrence is associated with higher 
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survival compared to detection by a clinician, highlighting the importance of patient vigilance. Yet 
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despite SSE being universally recommended by clinical guidelines, education and practice remains 
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suboptimal, with less than half of respondents in a study of melanoma patients in NSW [paper 
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currently under review], and only 14% in an American study12,  indicating that they examined all 
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parts of the body. In fact current evidence suggests that few people carry out SSE thoroughly, with 
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many failing to view hard-to-see areas, seeking assistance by a partner, or documenting lesions 
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that they need to check again to notice changes13.    
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5.2. Justification/ Significance 
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This pilot study is the first to evaluate the feasibility of patient-led surveillance through: Web-based 
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version of the ‘ASICA skin checker’ App (instructional videos, guided self-examination and 
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electronic reporting), Smartphone App using teledermatoscopy of patient detected lesions (detailed 
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images transmitted electronically for dermatology review), email + SMS reminders + educational 
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booklet + scheduled and unscheduled clinic visits. It will support planning for a large trial to 
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compare the effects of patient-led surveillance and clinician-led surveillance on health outcomes, 
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psychological outcomes and resource use.   The larger study will aim to demonstrate that patient-
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led surveillance results in health outcomes that are at least as good as clinician-led surveillance, 
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with better psychological outcomes and less health resource use.  Our work will allow for evidence-
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based follow-up after treatment of localised melanoma, to maximise patient wellbeing and the early 
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detection of new or recurrent melanoma, while minimising costs to the health system. 
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5.3. Lay summary 
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Background and Aim: Most melanomas are detected by patients or family members between 
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scheduled visits; Even more might be detected if patients are trained in how to self-examine their 
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skin and have access to timely dermatology review. Frequent follow-up of localised melanoma is 
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time and resource intensive and has not shown improved outcomes. This pilot study, and the larger 
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one that will follow, aim to provide evidence on the best model of follow-up care after treatment for 
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localised melanoma.   
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Research Design: This proposal is for a pilot randomized controlled trial among patients who have 
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had surgery for localised melanoma and are followed up at recruiting skin cancer specialist clinics 
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or general practice clinics. We will compare the effects of offering patient-led surveillance (Web-
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based version of the ASCIA skin checker + dermatoscope + Teledermatology + email and text 
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reminders to support self-examination + an educational booklet + scheduled and unscheduled clinic 
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visits) to clinician-led surveillance (an educational booklet + scheduled and unscheduled clinic 
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visits). We will document how well participants are able to perform self-examination, their levels of 
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melanoma-related anxiety, the number of skin lesions biopsied or removed, and the costs of follow-
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up to the participant, to the healthcare system, and to the planet (in the form of carbon emission 
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costs). We will recruit 100 people who have been treated for a first primary localised melanoma, 
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own a smartphone, and are being followed up at a recruiting skin cancer specialist clinic or general 
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practice clinic. Potential participants will be screened in clinic by the treating clinician. Potential 
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participants will be given the study invitation package either in clinic or by mail out.  Patients who 
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are found to be eligible and who consent to participate will be randomised to patient-led 
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surveillance or clinician-led surveillance. Participants will be sent questionnaires at six months to 
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measure outcomes using paper or online surveys. We will also collect data through the web-based 
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version of the ASICA skin checker (in the intervention group), patient diaries (to measure out of 
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pocket costs), and from the clinic databases (including follow-up visits, surgical procedures and 
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pathology reports of any skin lesions removed). 
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6. Study design  
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6.1. Research question(s)/ aim(s):  
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The primary aim of the study is to investigate whether patient-led surveillance (Web-based version 
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of the ASICA skin checker + smartphone App and dermatoscope attachment + Teledermatology + 
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email/SMS reminders) is feasible. 
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The secondary aims are to investigate whether patient-led surveillance: 
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1. increases patients’ adherence with recommended SSE practice (total body self-examination 
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conducted two- monthly) 
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2. improves confidence in, knowledge of, attitudes and beliefs about, skin self-examination, 
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3. decreases level of fear of new or recurrent melanoma, general anxiety, stress and 
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depression,  
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4. decreases the number of lesions surgically excised, the number of follow up visits attended 
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(both scheduled and unscheduled), resource use and costs and carbon emissions (costing 
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study) 
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5. Increases acceptability of reducing scheduled clinic visit frequency 
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6.   has acceptable inter-rater reliability for the Teledermatology assessment (reliability sub-
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study) 
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7.   is accepted by clinicians and patients views (qualitative sub-study) 
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6.2. Study design 
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This study is a 2-armed RCT with 1:1 allocation to intervention vs the control group, with a 
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Teledermatology repeatability sub-study nested within the intervention arm to estimate the inter-
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rater reliability of Teledermatology.  
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In addition, we will conduct a costing study to estimate the total costs to the health system, to 
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patients, and to the planet (carbon emissions) for the intervention and control groups. All costs 
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associated with SSE, skin surveillance and management of newly identified lesions, out of-pocket 
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costs and opportunity costs will be included. We will also measure and value all resources used 
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(micro-costing approach) to estimate the carbon emissions associated with melanoma surveillance 
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for the intervention and control groups. 
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We will conduct a qualitative sub-study to understand patients’ and clinicians’ acceptability and 
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satisfaction with the intervention and explore components which may need to be changed. The 
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qualitative evaluation will be in the form of phone or face to face interviews at the end of the 6 
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month follow-up. 
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7. Study population 
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We will recruit adult participants who have been treated for a first primary melanoma, stage 0/I/II, 
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and who are undergoing regular melanoma follow-up at recruiting melanoma and skin cancer 
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clinics in NSW.  
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This pilot study aims to recruit 100 patients from the Melanoma Institute Australia (MIA) and Royal 
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Prince Alfred Hospital (RPAH) (specialist treatment centres) and the Newcastle Skin Check clinic 
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(GP run clinic). Recruitment will be done over six months. 
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7.1. Inclusion Criteria 
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 
Patients treated for stage 0/I/II melanoma who are attending regular melanoma follow-up as 
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indicated by scheduled or recommended visit within next 12 months.  
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 
Are able to self-examine;  
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 
Have a suitable study partner (spouse, partner, family member, friend) to help with self-
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examination  
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 
Own a compatible Smartphone (and have access to Wifi / email / SMS text messaging); 
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 
Are able to give informed consent; 
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 
Have sufficient English language skills to read the materials and complete the 
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questionnaires; 
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 
Aged 18+ years old. 
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7.2. Exclusion Criteria 
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 
unable to perform self-examination 
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 
Patient who currently or previously have had stage III/IV melanoma  
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 
Patients with a known past or current diagnosis of cognitive impairment 
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8. Study procedures 
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8.1. Enrolment procedure 
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All patients treated for localised melanoma who are attending regular follow-up, will be identified in 
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clinic by the clinician. The potential participant will be contacted by a research coordinator who will 
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explain the study and give the patient an invitation package either in person or by mail.  The initial 
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study invitation package includes: Study Invitation Letter, Participant Information Sheet, Consent 
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Form, Participation Card, Baseline Questionnaire (to measure demographics, knowledge, attitudes 
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and confidence on self-examination and smartphone Apps, and their baseline level of fear of new 
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or recurrent melanoma (using a melanoma specific version of the Fear of Cancer Recurrence 
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Inventory Severity subscale)14 and reply paid envelope. The letter of invitation will be printed on the 
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clinic letterhead and will be signed by patients’ treating clinician, preferably as original signatures 
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but alternatively using electronic signatures with their permission. Participants will be able to opt 
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into the study by returning the signed consent form and participation card to the researchers by 
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reply paid mail or to decline study participation by returning the participation card, or by phone or 
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email. Potential participants will be asked to indicate whether they meet each of the inclusion 
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criteria (e.g. own a  compatible Smartphone etc.) and to specify on their participation card how they 
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would like to receive the study dermatoscope and questionnaires reminders (on Text SMS or 
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email). Participants who do not return their consent form or participation card within two weeks will 
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be contacted via telephone by the research staff. If the participant does not return their consent 
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form after this telephone call, no further contact will be made. Participants that do not respond will 
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be recorded as screen fails. The clinic staff will be informed which patients have agreed to 
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participate in the study. 
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Consenting participants will then be sent a baseline package in the mail. 
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8.2. Stratification and Randomisation  
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Patients will be stratified by the following factors:  
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 
AJCC Melanoma Stage (0, IA, IB, IIA, IIB/IIC) 
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 
Sex/gender (male/female) 
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 
Age group (18–40, 40–60, 60+) 
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 
Clinic type (GP clinic/specialist clinic)  
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Patients will be randomised 1:1 taking into account the above listed stratification factors using a 
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randomisation to one of two study arms:  
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Randomisation will be performed using the offsite randomisation service provided by the NHMRC 
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Clinical Trials Centre, The University of Sydney, thus ensuring allocation concealment. The 
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research coordinator will call the NHMRC Clinical Trials Centre (using their telephone 
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randomisation service) to randomise the patient once a consent form and the baseline 
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questionnaire has been received. Consenting patients who meet all inclusion/exclusion criteria will 
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be randomised in a ratio of 1:1 to the intervention or usual care.  
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Full instructions on how to randomise patients are described in the Operations Manual.  
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8.3. Interventions/ Groups 
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Participants allocated to the intervention will receive: 
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 
An educational booklet ‘Your guide to early melanoma’,  
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 
Web-based ASICA skin checker log-in. The web-based ASICA skin checker combines 
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instructional videos, guided total skin self-examination and electronic reporting,15 
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A dermatoscope to attach to their phone similar to that reported in Manahan et al.16.  
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Detailed written instructions on how to use the smartphone App and dermatoscope. 
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 
Video outlining how to use the dermatoscope and associated App/online submission 
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platform. 
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 
Email or SMS text reminders every 2 months to perform SSE.  
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 
Teledermoscopy:  participants are required to take dermoscopic images of at least 3 lesions 
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and up to 9 lesions on each SSE, including all lesions that concern them, and submit these 
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through the smartphone App. They are also required to enter a text description of the results 
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of SSE for each part of the body and submit this through the web-based ASICA skin 
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checker. Both dermoscopic images and text reports will be sent securely to one of the study 
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dermatologists, who will undertake teledermatology review within 3 days and feedback the 
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results to the participant.  
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Unscheduled visits as needed in addition to those prompted through Teledermatology. 
424 
 
Scheduled visits as per treating clinician. 
425 
 
426 
Those allocated to the control arm will receive: 
427 
 
An educational booklet ‘Your guide to early melanoma’; 
428 
 
Unscheduled visits as needed 
429 
 
Scheduled visits as per treating clinician 
430 
 
431 
All participants will receive two study questionnaires; one at baseline and one at 6 months. 
432 
 
433 
8.4. Blinding  
434 
Blinding of participants, site staff and treating clinicians will not be possible in this trial. Where 
435 
possible, outcome assessment will be done masked to study group allocation.  
436 
 
437 
8.5. Duration of treatment/ Study 
438 
Unless the study is closed prematurely, it will proceed to the pre-defined accrual target. Following 
439 
announcement of closure to recruitment by the research team, no further enrolment will be 
440 
possible. It is anticipated, based on estimates from individual sites that the accrual target will be 
441 
reached over a period of 6 months. Each participant will be followed up for 6 months. The timeline 
442 
below provides an outline of anticipated study milestones: 
443 
 
444 
 
445 
 
446 
 
447 
 
448 
 
449 
 
450 
 
451 
 
452 
 
453 
 
454 
 
455 
 
456 
 
457 
 
458 
 
459 
 
460 
 
461 
 
462 
8.6. Asses
463 
Timeline 
2017 
2018 
2019 
2020 
Apply for ethics approval and 
preparation of study materials 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Recruitment & random allocation 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
6 month follow-up data collection 
and entry 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Analysis of 6 months follow up 
data finalised and paper drafted 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Qualitative phone interview study  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Costing study 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data cleaning, statistical and cost 
analyses 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Paper & Dissemination 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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sment schedule and follow up 
464 
Follow-up: All participants will be complete a questionnaire at baseline (T0: prior to randomisation) 
465 
and 6 months (T1) follow-up which they can complete in hard copy or online. Data will be extracted 
466 
from clinic databases for 6 months from randomisation, including surgical procedures and 
467 
histopathology. 
468 
8.6.1. Follow-up questionnaire (T1): 6 months 
469 
Participants will be mailed the first follow-up questionnaire (or provided with a link to the online 
470 
survey via email) 6 months after randomisation. If participants do not return their completed 
471 
questionnaire within 1 week of postage or email, the researchers will contact the participant by 
472 
SMS text and/or email (according to the participant’s preferred method of contact) as a reminder 
473 
about the study. The researchers will remind the participant 5 times. If there are delays with the 
474 
return of the questionnaire, and the participant appears to have problems completing the 
475 
questionnaire on paper or online, the research coordinator will offer to administer the questionnaire 
476 
over the telephone. 
477 
 
478 
8.6.2. End of study. 
479 
Measurement of outcomes will be at 6 months (T1questionnaire) for evaluation of intervention 
480 
effects. If a patient has not completed the schedule of follow up visits, further follow up of outcomes 
481 
will continue up to a maximum of 12 months. If a patient withdraws consent to participate, a Study 
482 
Discontinuation Form will be completed (see below). 
483 
 
484 
Similarly, if a patient dies, a Study Discontinuation Form will be completed and a copy of the death 
485 
certificate or discharge summary provided. Reason for death, melanoma/skin cancer related or not, 
486 
will be considered in the final analysis. 
487 
 
488 
8.6.3. Withdrawal and Lost to Follow up 
489 
Participation in this study is voluntary; patients are able to withdraw at any time.  
490 
 
491 
If a patient decides to stop their follow-up visits but is willing to keep in contact via telephone, their 
492 
health status will be periodically ascertained by way of phone contact with their general practitioner 
493 
or by direct phone contact with the patient.    
494 
 
495 
For those patients who want to have no further contact, all correspondence regarding the trial will 
496 
be discontinued. A Study Discontinuation Form is to be completed at the last study visit the patient 
497 
attends and this is to be submitted to the Trial Coordinating Centre. 
498 
 
499 
The National Death Index at the Australian Institute of Health and Welfare and other local 
500 
databases, including clinic databases, may be used to collect outcome information on patients who 
501 
have been lost to follow-up. 
502 
9. Data Collection 
503 
Trial data will be recorded in full on the CRFs (hardcopy to each site) or eCRFs (eDatabase). 
504 
 
505 
The site is required to complete all appropriate data entry fields as specified on the forms.  The 
506 
investigator will be asked to confirm the accuracy of completed CRFs by signing forms as indicated. 
507 
Source documents pertaining to the trial must be maintained by investigational sites. Source 
508 
documents may include a subject's medical records, hospital charts, operation reports, the 
509 
investigator's subject study files, as well as the results of diagnostic tests such as laboratory and 
510 
pathology results.  
511 
 
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The Trial Management Centre (TMC) may request copies of some source documents in support of 
513 
the CRF as a quality assurance exercise. All study-related documentation is required to be 
514 
maintained by the site for 15 years following completion of the study. 
 
515 
10. Intervention 
516 
10.1. 
Intervention and comparison arms 
517 
The intervention comprises:  
518 
 
The web-based ASICA (Achieving Self-directed Integrated Cancer Aftercare) Skin-
519 
Checker is used to record regular Skin Self-Examination.15 The patient will be prompted to 
520 
perform a skin exam every two months. When the patient discovers a skin change or lesion, 
521 
the patient will report the changes on the web-based ASICA survey. The skin report 
522 
contains a description of the change or lesion and where it is located. Participants are 
523 
required to provide text reports on each part of the body before they can proceed with 
524 
submitting the report through the site (if there are no concerning changes/lesions then this is 
525 
reported for each part of the body).  
526 
 
Dermatoscope and Teledermatology: Smartphone App and dermatoscope that can be 
527 
attached to a smartphone for patients to use.  The device allows magnified images of skin 
528 
lesions to be taken under polarized light for electronic transmission to a specialist. This store 
529 
and forward process is called “mobile teledermatology”.  Three dermatologists will be 
530 
rostered on to review the reports and images of patient detected lesions, and feedback 
531 
recommendations to the patient as to the action that needs to be taken. They will report 
532 
results within 3 working days of receiving the electronic text report and images from the 
533 
patient. If the report is not reviewed in this timeframe the site study coordinator will notify the 
534 
patient of a delay in reporting. They will provide one of the following recommendations:  
535 
o Follow Up Photo - There is no immediate concern today, but this case should 
536 
continue to be monitored. Please take another picture and resubmit for review.   
537 
o Retake Photo - Unfortunately, the image quality is not sufficient for 
538 
teledermatology review. Please retake the photo.  
539 
o Clinical Exam - We recommend that you book an appointment with your doctor 
540 
to examine this case. Please call your melanoma clinic to make an appointment 
541 
at your earliest convenience. 
542 
o No Concern Today - This case does not seem to be suspicious at this time. Self-
543 
monitor and review with your doctor at your next scheduled visit.  
544 
o Biopsy/Excision - We recommend that you book an appointment with your doctor 
545 
to examine this case as biopsy or excision may be needed. Please call your 
546 
melanoma clinic to make an appointment at your earliest convenience.   
547 
o Other   
548 
 
Educational booklet ‘Your guide to early melanoma’: The freely available booklet developed 
549 
by the Melanoma Institute Australia for patient support and comprises a treatment-
550 
management organiser and detailed information source in one booklet. Contents include: - 
551 
Diagnosis summary - Melanoma glossary - Treatment plan - Pain diary - Medication chart - 
552 
Body maps for self-examination - Frequently asked questions - Supportive services - 
553 
Information on treatments and surgical procedures 
554 
 
Written and video instructions on how to use the dermatoscope + Smartphone App  
555 
 
Email and/or SMS text reminders every 2 months to perform self-examination 
556 
 
Unscheduled visits as needed in addition to those prompted through Teledermatology 
557 
 
Scheduled visits as needed  
558 
 
Monthly diaries capturing clinic visits and travel costs 
559 
 
560 
The control arm comprises  
561 
 
An educational booklet ‘Your guide to early melanoma’; 
562 
 
Unscheduled visits as needed  
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Scheduled visits as needed  
564 
 
Monthly diaries capturing clinic visits and travel costs 
565 
 
566 
10.2. 
Intervention/ treatment modification 
567 
Participation in this study does not stop participants in either the intervention or control groups from 
568 
seeking professional medical care. Access to formal health services will, however, be recorded as 
569 
part of the study. 
570 
10.3. 
Distribution, packaging and labelling 
571 
The initial Invitation letter will be sent on clinician letterhead to the participant at the address on file 
572 
at the clinic database. Following consent and receipt of the baseline study questionnaire, the study 
573 
packages will be distributed by the research coordinator, according to their random intervention or 
574 
control group allocation, to participants through the mail or during their routine clinic visit (as 
575 
directed by participant preference). 
576 
10.4. 
Accountability for intervention 
577 
It is the responsibility of the research coordinator to make sure that all participants receive their 
578 
packages according to their randomised group allocation. 
579 
11. Safety Reporting 
580 
11.1. 
Adverse Events 
581 
An Adverse Event (AE) can be any unfavourable and unintended sign, symptom, or disease 
582 
temporally associated with the use of an intervention, whether or not related to the intervention. 
583 
 
584 
In cases of surgical or diagnostic procedures, the condition/illness leading to such a procedure is 
585 
considered as the AE rather than the procedure itself. 
586 
 
587 
Medical device adverse event / incident: 
588 
 
An event associated (caused or partially attributable) with the use (or misuse) of a 
589 
medical device. 
590 
 
An event that resulted in or could have resulted in (had effective intervention not taken 
591 
place) serious injury, illness or death to patient, healthcare worker or other person. 
592 
 
Faults that may affect the quality of device, timeliness of assessment and cost-
593 
effectiveness such as, problems with getting the device to operate, repeated repairs, 
594 
device design and difficulty of use. 
595 
 
596 
All AEs with the smartphone App and dermatoscope will be recorded and reviewed by the trial 
597 
management committee. 
598 
 
599 
11.2. 
Serious Adverse Events 
600 
SAE Definitions 
601 
A serious adverse event (SAE) is any untoward medical occurrence which: 
602 
 
is fatal; 
603 
 
is life-threatening; 
604 
 
requires unanticipated in-patient hospitalisation or prolongation of hospitalisation; 
605 
 
results in persistent or significant disability or incapacity;  
606 
 
is a congenital anomaly/birth defect; 
607 
 
is a grade 4 (NCI CTCAE v4.0) toxicity; 
608 
and 
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could be related to the device and/or software 
610 
The term “life threatening” in the definition of SAE refers to an event in which the participant was at 
611 
risk of death at the time of the event; it does not refer to an event which, hypothetically, might have 
612 
caused death if it were more severe. 
613 
 
614 
SAE Reporting 
615 
All relevant and subsequent information relating to each reported SAE must be submitted on the 
616 
CRF, along with any available source documentation, to the Trial Coordinating Centre. This must 
617 
be completed within 24 hours of the site becoming aware of the event and all SAE CRFs require 
618 
the signature of the Principal Investigator.  
619 
 
620 
SAE Reporting Timelines 
621 
Type 
Timeframe 
Initial SAE Report 
The site must submit the original SAE Form to the Trial Coordinating 
Centre within 24 hours of becoming aware of a trial participant 
experiencing an SAE. Please provide copies of relevant source 
documents if available. Should the site have any questions please 
immediately contact the Trial Coordinating Centre for assistance. 
Updated Report 
The site should provide any updates to the Trial Coordinating Centre as 
soon as possible. Please use the original SAE Form, and use additional 
Forms if more space is required. Please provide copies of all relevant 
source documents if available. 
Completed Report 
Once the event has resolved or if the participant has died, using the 
original SAE Form(s), the site should provide the complete report to the 
Trial Coordinating Centre as soon as possible. This must include relevant 
source documents. 
 
622 
All SAEs will be reviewed by the Study Chair and also summarised for review by the Data Safety 
623 
Management Committee. 
624 
 
625 
SAEs will be reported as per the local Ethics Committee (EC)/Research Governance Officer (RGO), in 
626 
accordance with international and local laws and regulations.  
627 
 
628 
Should any trial site have any questions they will immediately contact the Trial Coordinating Centre for 
629 
assistance. 
630 
12. Outcomes/ Measures 
631 
12.1. 
Primary outcome 
632 
(M1) The primary outcome is the proportion of patients who are invited to participate who are 
633 
finally randomised into the trial. 
634 
12.2. 
Secondary outcomes 
635 
(M2) Skin –Self Examination (SSE) including: 
636 
M2.1. Adherence with recommended SSE practice (total body self-examination conducted two- 
637 
monthly); Participants will be asked how often they perform a complete examination of their skin.  
638 
M2.2. Thoroughness, confidence, beliefs, attitude, and knowledge of SSE will be assessed by 
639 
items adapted from Janda et al. 
640 
 (M3) Level of fear of new or recurrent melanoma (FCR) severity: FCR will be assessed using a 
641 
modified (i.e. melanoma-specific) version of the 9 item Fear of Cancer Recurrence Inventory (FCRI) 
642 
severity subscale, the most comprehensive multi-dimensional scale of FCR available.7 A higher 
643 
score is indicative of greater FCR.   
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(M4) General anxiety, stress and depression: Anxiety, stress and depression will be measured 
645 
using the short version of the Depression Anxiety and Stress Scales (DASS-21).17 The DASS-21 is 
646 
a set of three 7-item self-report scales designed to measure the emotional states of depression, 
647 
anxiety and stress. The depression scale measures dysphoria, hopelessness, devaluation of life, 
648 
self-deprecation, lack of interest/involvement, anhedonia and inertia. The anxiety scale measures 
649 
autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of 
650 
anxious affect. The stress scale assesses difficulty relaxing, nervous arousal, and feeling irritable 
651 
and impatient. 
652 
(M5) Acceptability of reducing scheduled clinic visit frequency: will be measured through 
653 
item(s) designed specifically for this questionnaire.   
654 
(M5)  Number of lesions surgically evaluated; 
655 
(M6)  Number of clinic visits attended (both scheduled and unscheduled)  
656 
(M7) Inter-rater reliability for the Teledermatology assessment: We will carry out a repeatability 
657 
study after trial close-out where the three study dermatologists independently report on cases they 
658 
did not provide teledermatology assessment for during the trial. We will compare results across the 
659 
three dermatologists to assess agreement.  
660 
(M8) Resource use: Patient out of pocket and health system costs associated with each arm of the 
661 
trial will be estimated using a resource use diary. The diary will be used to document and measure 
662 
health behaviours and service use - such as hospitalisation, other allied health consultations, use of 
663 
alternative therapies and self-monitoring behaviours. The diary will also document days out-of-role 
664 
(including paid and unpaid work), travel costs and carer costs. The diary will be based on existing 
665 
resource use questionnaires resource use recorded in databases. 
666 
(M9) Qualitative results: We will carry out face-to-face or telephone interviews with a sub-set of 
667 
intervention group participants at 6 months after randomisation to explore in depth patients’ 
668 
experiences with digitally supported self-examination. We will also interview clinicians to explore 
669 
their experience of the benefits and limitations of the intervention. 
670 
12.3. 
Potential confounders and biases 
671 
(M10) Demographic and other risk factors including: 
672 
Age, sex, ethnicity, Indigenous status, language spoken, marital status, children, occupation, 
673 
income, highest education level, postcode/SEIFA, brand of smartphone owned (if applicable), 
674 
baseline use of digital technology/ internet, and personal history of depression or anxiety. We will 
675 
collect these data using standardised items from the Australian Census questionnaire and other 
676 
instruments, where appropriate.  
677 
Clinical characteristics of the index melanoma including AJCC sub-stage and site, retrieved from 
678 
administrative datasets at the clinics.  
679 
13. Statistical methods 
680 
13.1. 
Sample size and justification 
681 
A sample size of 100 participants, with 1:1 allocation to intervention vs control groups, will ensure 
682 
that the 95% confidence interval for the proportion of potential participants who are recruited has a 
683 
margin of error of <10% (assuming that 30% of contacted, eligible participants are recruited).  
684 
 
685 
A sample size of 30 participants in the qualitative sub-study is a well-accepted sample size in 
686 
qualitative studies using in-depth interviews.18 
687 
 
688 
13.2. 
Feasibility 
689 
Administrative data from our main clinic (MIA) indicates that approximately 800-900 patients are 
690 
treated for localised melanoma at MIA each year and approximately 50% then attend regular 
691 
follow-up at MIA.19  Recruiting 100 patients over 6 months from all patients treated for localised 
692 
melanoma who are attending follow-up at MIA and the clinic in Newcastle, is highly feasible.  
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694 
13.3. 
Early stopping 
695 
There are no safety endpoints or criteria for early study termination. 
696 
 
697 
13.4. 
Analyses plan 
698 
13.4.1. 
Statistical analysis for primary endpoint 
699 
The proportion of patients who are randomised into the trial will be estimated using the number of 
700 
contacted patients as the denominator. The Wilson (score) method will be used to estimate the 
701 
confidence interval for this proportion to assess the best and worst case scenarios supported by the 
702 
pilot study data. We will investigate and describe any groups that had low participation rates in our 
703 
pilot study. 
704 
 
705 
 
706 
13.4.2. 
Statistical analysis for secondary endpoints 
707 
We will use a chi-squared test to investigate the difference in proportion undertaking regular skin 
708 
self-examination between the intervention arm and the usual care arm. A t-test will be used to 
709 
compare fear of new or recurrent melanoma severity at 6 months between the intervention and 
710 
usual care group. We will report any estimated differences (either proportions or means) with 
711 
appropriate confidence intervals as the power for these comparisons will be limited. 
712 
 
713 
13.5. 
Secondary analyses 
714 
Teledermatology Repeatability Study  
715 
Sub-study to assess Dermatologist diagnostic agreement of electronic text reports and images 
716 
collected during the trial. 
717 
We will assess inter-rater agreement across three dermatologists, reporting on prospectively 
718 
collected Teledermatology materials. After close-out of the trial, three dermatologists (CIs Guitera, 
719 
Soyer and Mar) will independently review all electronic reports and images of patient detected 
720 
lesions that they did not report on during the trial. All three dermatologists will report their results 
721 
blinded to those of the other two dermatologists and to any other clinical information apart from that 
722 
received during the Teledermatology (age and sex of patient and the text report describing the 
723 
lesion where this was provided).  
724 
Agreement across the following broad clinical diagnostic categories will be calculated: 
725 
 No concern today [i.e. benign] 
726 
 Follow up photo [i.e. low probability of melanoma/NMSC]  
727 
 Clinical Exam [i.e. intermediate probability of melanoma/NMSC] 
728 
 Biopsy/excision [i.e. high probability of melanoma/NMSC] 
729 
 Only one category per patient episode allowed, where teledermatologist makes more than 
730 
one diagnosis, most severe diagnostic category used.  
731 
We will construct cross-classification tables to separately compare inter-rater reliability for text 
732 
report + macroscopic image and for text report + dermoscopic image. We will calculate percentage 
733 
agreement and kappa statistics across diagnostic categories and 95% confidence intervals for 
734 
these. 
735 
 
736 
Costing study 
737 
We will identify, measure and value all resources used (micro-costing approach) to estimate the 
738 
total costs to patients, to the health system, and to the planet (carbon emissions) for the 
739 
intervention and control groups. All costs associated with SSE, skin surveillance and management 
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of newly identified lesions, out of-pocket costs, opportunity costs and carbon costs will be 
741 
included.20  
742 
Patient diaries 
743 
Patient out-of-pocket and health system costs associated with each arm of the trial will be 
744 
estimated using a monthly resource use diary.21,22 The diary will be used to document and measure 
745 
health behaviours and service use - such as hospitalisation, other allied health consultations, use of 
746 
alternative therapies and self-monitoring behaviours. The diary will also record any melanoma 
747 
follow up consultations and procedures conducted by other providers (e.g. GPs). We will ask 
748 
patients to report the number of trips made to their melanoma follow-up clinic and the mode of 
749 
transport used. We will also ask patients to report any visits to other physicians in the community 
750 
for a skin lesion excision or other skin cancer related procedures. The time each patient spent to 
751 
perform digital SSE and to attend follow-up visits will be recorded. The diary will also document 
752 
carers’ days out-of-role (including paid and unpaid work), travel costs and direct carer costs.  
753 
Review of medical records 
754 
All recorded melanoma follow up consultations and procedures will be extracted from the patients’ 
755 
medical records in the clinic databases. We will also extract all diagnostic tests during the trial 
756 
period. 
757 
The mean (and standard deviation) volume of resource use by category and mean cost per 
758 
participant will be tabulated. The difference in resource use and costs between the intervention and 
759 
control groups will be presented with 95%CIs, and P- values for differences will be calculated by 
760 
two sample t-tests. 
761 
Carbon Costs 
762 
We will then apply a carbon value to each of the types of resource use identified above. This will 
763 
include direct estimation (e.g. travel) and indirect (e.g. life cycle costs of a tablet/smartphone). We 
764 
will do this using data from the Australian Industrial Ecology Virtual Laboratory (IELab), which offers 
765 
a unique platform for the compilation of customized economic input-output tables for the Australian 
766 
economy. As a first step, we will couple these economic tables with data on carbon emissions for 
767 
every economic sector. Next, we’ll use these integrated tables to undertake well-established input-
768 
output mathematical calculations to estimate the direct impacts, as well as the indirect impacts 
769 
throughout the infinite supply chains of a product, for example. As opposed to conventional life 
770 
cycle assessments that are affected by so-called truncation errors because they only take into 
771 
account selected supply chains, input-output analysis considers the entire supply chain of a 
772 
product, technology or an organization in question, and this provides a complete picture of the 
773 
impacts.    
774 
 
775 
Qualitative sub-study (intervention group only) 
776 
We will conduct a qualitative evaluation after the 6 month follow up among a sub-sample of patients 
777 
and clinicians. We will invite participants who were randomised to the intervention to indicate their 
778 
interest in taking part in a interview (number of participants=30) to explore in depth their 
779 
experiences with digitally supported self-examination. We will carry out face-to-face or telephone 
780 
interviews among these patients at 6 months after randomisation. Interviews will be audio recorded 
781 
and transcribed verbatim. We will also interview participating clinicians (n=5-10) to explore their 
782 
experience of the benefits and limitations of the intervention. The study will take a 
783 
Phenomenological perspective and will use Framework Analysis,23 a matrix based method of 
784 
thematic analysis which has been used successfully in numerous screening studies.24,25 
785 
13.6. 
Missing data 
786 
Missing data will be imputed in analysis as appropriate.  
787 
13.7. 
Deviations from original statistical plan 
788 
The version of this document and the statistical analyses plan will be updated with each change, 
789 
and each change noted. 
790 
 
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14. Responsibilities of the Principal Investigator at each site 
792 
 
793 
The study will be performed in accordance with the CPMP/ICH Note for Guidance on Good Clinical 
794 
Practice (CPMP/ICH/135/95) in Australia and applicable guidelines in participating sites overseas.  
795 
 
796 
The study protocol, including the final version of the participant information and informed consent 
797 
form to be used, must be approved by the Trial Management Committee and a constituted Human 
798 
Research Ethics Committee (HREC) prior to enrolment of any patients into the study. The opinion 
799 
of the HREC should be dated and given in writing. It is the responsibility of the PI at each site to 
800 
forward a copy of the approval from the HREC clearly identifying the protocol submitted for review 
801 
and a copy of the approved participant information sheet and consent form to the Trial Coordinating 
802 
Centre prior to entry of patients. 
803 
 
804 
The investigator is responsible for ensuring that written informed consent by the patient is obtained 
805 
before study entry. The investigator is responsible for informing the Trial Coordinating centre and 
806 
the HREC of any SAEs and/or major amendments to the protocol as per local requirements. 
807 
 
808 
The investigator is responsible for ensuring that all regulatory requirements are followed.  
809 
 
810 
The investigator is required to ensure compliance with the protocol in its entirety. It is the 
811 
responsibility of the investigator to maintain adequate and accurate CRFs.  
812 
 
813 
15. Reporting of Results 
814 
 
815 
The Study Chair and TMC will be responsible for decisions regarding presentations and 
816 
publications arising from this study.  
817 
 
818 
Authorship credit should be based on the Vancouver statement by the International Committee of 
819 
Medical Journal Editors, i.e. substantial contribution to all three of the following criteria:  
820 
 
Conception and design OR analysis and interpretation 
821 
 
Drafting article OR critically revising it for intellectual content 
822 
 
Final approval of version to be published 
823 
Or, a fourth criterion is: 
824 
 
Contributors who register 5% or more (accrual by institution) of the evaluable cases on a 
825 
study will be listed as authors. The designated author is the choice of the institution’s PI and 
826 
in most cases would be the investigator with the highest accrual. If an institution places a 
827 
large number of cases on the study, that institution will get an additional author for every 10% 
828 
of the participants accrued, not to exceed a total of three authors (i.e. two authors for > 15% 
829 
accrual and three authors for > 25% accrual) 
830 
 
831 
Acknowledgement of the collaboration between MASC Trials is required in all publications, 
832 
abstracts and presentations. Publications and abstracts must be presented to the Study Chair and 
833 
TMC for review and approved prior to submission. Draft publications will be presented to the 
834 
Publications/Writing Committee of each collaborating group for comment prior to submission. 
835 
 
836 
Publications must be reviewed by the MASC Trials Executive Committee prior to submission. 
837 
 
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16. Quality Assurance 
839 
16.1. 
Data Management and Source Data Verification 
840 
Trial sites are expected to regularly provide the completed CRFs reflecting the patient visits to the 
841 
Trial Coordinating Centre. Copies of relevant documents for source verification and quality 
842 
assurance will be requested including various imaging scans and reports. 
843 
 
844 
The Trial Coordinating Centre will issue data queries as required to clarify CRF data and will report 
845 
to the Study Chair regarding CRF submission and query completion rates as well as any issues 
846 
related to protocol compliance. 
847 
16.2. 
Protocol Amendments 
848 
Changes and amendments to the protocol can only be made by the TMC.  Approval of amendments 
849 
by the HREC is required prior to their implementation.  In some instances, an amendment may 
850 
require a change to the participant information sheet and/or consent form.  The Investigator must 
851 
receive approval/advice of the revised consent form prior to implementation of the change.  In 
852 
addition, changes to the CRFs, if required, will be incorporated in the amendment. 
853 
16.3. 
On Site Monitoring 
854 
Site monitoring is scheduled annually for this study (also subject to funding and recruitment rate 
855 
and at the discretion of the TMC).  
856 
16.4. 
Site Audits 
857 
This study is subject to audit by each of the groups involved and could occur at any stage of the 
858 
study.  Sites will be informed in advance in writing, outlining and the scope of the audit should one 
859 
occur. 
860 
16.5. 
Confidentiality 
861 
The study will be conducted in accordance with applicable Privacy Acts and Regulations.  All data 
862 
generated in this study will remain confidential.  All information will be stored and backed-up 
863 
securely at the MASC Trials Coordinating Centre or at the School of Public Health at University of 
864 
Sydney and will only be available to staff directly involved with the study. Hard-copy documents will 
865 
be stored in locked cabinets. Electronic files will be stored on secure servers and files containing 
866 
identifying information are password-protected. 
867 
 
868 
Personal data identifying trial subjects will be held securely at the sites according to local 
869 
institutional requirements for the purpose of follow up after the conclusion of the protocol-specified 
870 
period.  Sites may be asked to submit copies of source documents to the Trial Coordinating Centre 
871 
e.g. pathology reports, however, all reports must be de-identified prior to sending, with only 
872 
participant trial number and initials detailed.   
873 
 
874 
17. References  
875 
 
1. 
Welfare AIoHa: Cancer incidence projections, Australia 2011 to 2020. Cancer series no. 66. . 
876 
Canberra, 2012 
877 
 
2. 
Speijers MJ, Francken AB, Hoekstra-Weebers JE, et al: Optimal follow-up for melanoma. 
878 
Expert Review of Dermatology 5:461-478, 2010 
879 
 
3. 
Australia Cancer Network & New Zealand Guidelines Group: Clinical Practice Guidelines for 
880 
the Management of Melanoma in Australia and New Zealand, 2008 
881 
 
4. 
Coory M, Baade P, Aitken J, et al: Trends for in situ and invasive melanoma in Queensland, 
882 
Australia, 1982-2002. Cancer Causes Control 17:21-7, 2006 
883 
 
5. 
Morton RL, Rychetnik L, McCaffery K, et al: Patients' perspectives of long-term follow-up for 
884 
localised cutaneous melanoma. Eur J Surg Oncol 39:297-303, 2013 
885 

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6. 
Rychetnik L, McCaffery K, Morton R, et al: Psychosocial aspects of post-treatment follow-up 
886 
for stage I/II melanoma: a systematic review of the literature. Psychooncology 22:721-36, 2013 
887 
 
7. 
Watts CG, Cust AE, Menzies SW, et al: Specialized surveillance for individuals at high risk 
888 
for melanoma: A cost analysis of a high-risk clinic. JAMA Dermatology, 2014 
889 
 
8. 
Turner RM, Bell KJL, Morton RL, et al: Optimizing the Frequency of Follow-Up Visits for 
890 
Patients Treated for Localized Primary Cutaneous Melanoma. Journal of Clinical Oncology 29:4641-4646, 
891 
2011 
892 
 
9. 
Damude S, Hoekstra-Weebers JEHM, Francken AB, et al: The MELFO-Study: Prospective, 
893 
Randomized, Clinical Trial for the Evaluation of a Stage-adjusted Reduced Follow-up Schedule in Cutaneous 
894 
Melanoma Patients—Results after 1 Year. Annals of Surgical Oncology:1-10, 2016 
895 
 
10. 
Rychetnik L, McCaffery K, Morton RL, et al: Follow-up of early stage melanoma: specialist 
896 
clinician perspectives on the functions of follow-up and implications for extending follow-up intervals. J Surg 
897 
Oncol 107:463-8, 2013 
898 
 
11. 
Dummer R, Hauschild A, Guggenheim M, et al: Cutaneous melanoma: ESMO Clinical 
899 
Practice Guidelines for diagnosis, treatment and follow-up. Annals of Oncology 23:vii86-vii91, 2012 
900 
 
12. 
Coups EJ, Manne SL, Stapleton JL, et al: Skin self-examination behaviors among individuals 
901 
diagnosed with melanoma. Melanoma Res 26:71-6, 2016 
902 
 
13. 
Yagerman S, Marghoob A: Melanoma patient self-detection: a review of efficacy of the skin 
903 
self-examination and patient-directed educational efforts. Expert Rev Anticancer Ther 13:1423-31, 2013 
904 
 
14. 
Simard S, Savard J: Fear of Cancer Recurrence Inventory: development and initial validation 
905 
of a multidimensional measure of fear of cancer recurrence. Support Care Cancer 17:241-51, 2009 
906 
 
15. 
Murchie P, Allan JL, Brant W, et al: Total skin self-examination at home for people treated for 
907 
cutaneous melanoma: development and pilot of a digital intervention. BMJ Open 5:e007993, 2015 
908 
 
16. 
Manahan MN, Soyer HP, Loescher LJ, et al: A pilot trial of mobile, patient-performed 
909 
teledermoscopy. Br J Dermatol 172:1072-80, 2015 
910 
 
17. 
Lovibond SH, Lovibond, P.F.    : Manual for the Depression Anxiety Stress Scales. (ed 2nd. 
911 
Ed.). Sydney, Sydney Psychology Foundation, 1995  
912 
 
18. 
Dworkin SL: Sample size policy for qualitative studies using in-depth interviews. Arch Sex 
913 
Behav 41:1319-20, 2012 
914 
 
19. 
Memari N, Hayen A, Bell KJ, et al: How Often Do Patients with Localized Melanoma Attend 
915 
Follow-Up at a Specialist Center? Ann Surg Oncol 22 Suppl 3:S1164-71, 2015 
916 
 
20. 
Watts CG, Cust AE, Menzies SW, et al: Specialized surveillance for individuals at high risk 
917 
for melanoma: a cost analysis of a high-risk clinic. JAMA Dermatol 151:178-86, 2015 
918 
 
21. 
Sanders GD, Neumann PJ, Basu A, et al: Recommendations for Conduct, Methodological 
919 
Practices, and Reporting of Cost-effectiveness Analyses: Second Panel on Cost-Effectiveness in Health and 
920 
Medicine. JAMA 316:1093-103, 2016 
921 
 
22. 
Husereau D, Drummond M, Petrou S, et al: Consolidated Health Economic Evaluation 
922 
Reporting Standards (CHEERS) statement. BMJ 346:f1049, 2013 
923 
 
23. 
Ritchie J LJ: Qualitative Research Practice: A Guide for Social Science Students and 
924 
Researchers. London, Sage, 2003  
925 
 
24. 
Smith SK, Dixon A, Trevena L, et al: Exploring patient involvement in healthcare decision 
926 
making across different education and functional health literacy groups. Soc Sci Med 69:1805-12, 2009 
927 
 
25. 
Waller J, McCaffery K, Kitchener H, et al: Women's experiences of repeated HPV testing in 
928 
the context of cervical cancer screening: a qualitative study. Psychooncology 16:196-204, 2007 
929 
 
930 
18. Appendices 
931 
 
932 
Table 1: Schedule of Assessment: Time and Events Table:  
933 
Follow on next page 29. 
934 

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935 
Study Treatment: 
Screening: 
 
Time: 
Staff Identify participants:  
 
Stage 0/I/II melanoma who are attending 
regular melanoma follow-up 
 
18 years or older  
 
Sufficient  English language skills 
 
Are able to self-examine   
 
No known cognitive impairment  
 
Follow up appointment planned 
 
Site staff identify participants  
 
 
Invitation package: 
 
 
Informed consent to study participation 
√ 
 
 
Before follow up 
appointment 
Patient Information Sheet  
√ 
Participation and Eligibility card  
√ 
Study Invitation Letter  
√ 
Prepaid envelope to return Consent  
√ 
Baseline Questionnaire (hardcopy)  
√ 
Eligible patient returns consent and participation card.  
Site staff performs patient randomisation. 
 
Time from randomisation: 
Control Arm 
Intervention Arm 
Welcome Package sent to participants. This include the following items: 
+/- 7 days 
 
Dermatoscope (By mail or face-to-face) 
 
 
√ 
Rubber attachment-(smartphone-specific) (By mail or face-to-face) 
 
 
√ 
Instructions for MoleScope App and Dermatoscope 
 
 
√ 
Participant diary for next 6 months and 6 prepaid envelopes 
 
√ 
√ 
“Your Guide to Early Melanoma Detection”  educational booklet 
 
√ 
√ 
Baseline letter- Control  
 
√ 
 
Baseline letter - Intervention  
 
 
√ 
Text/email reminders for Self-Skin Examination with ASICA survey code.   
Every 2 months 
 
√ 
6 month Follow-up package: 
6 months +/- 7 days  
 
 
6 month Follow-up Questionnaire (Hardcopy)  and prepaid envelopes (for those opting for 
paper version) 
 
√ 
√ 
6 month Letter – Control with REDCap code updated (Online) 
 
√ 
 
6 month  Letter- Intervention with REDCap code updated (Online) 
 
 
√