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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03581188
Registration number
NCT03581188
Ethics application status
Date submitted
18/06/2018
Date registered
10/07/2018
Date last updated
1/08/2023
Titles & IDs
Public title
Patient-led Surveillance Compared to Clinician-led Surveillance in People Treated for Localised Melanoma.
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Scientific title
A Randomised Controlled Pilot Trial of Patient-led Surveillance Compared to Clinician-led Surveillance in People Treated for Localised Melanoma.
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Secondary ID [1]
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ACTRN12616001716459
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Secondary ID [2]
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ANZMTG 02.17
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Universal Trial Number (UTN)
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Trial acronym
MEL-SELF
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Melanoma (Skin)
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Condition category
Condition code
Cancer
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Malignant melanoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Patient-led surveillance
Behaviour - Clinician-led surveillance
Experimental: Patient-led surveillance - Participants receive a mobile dermatoscope that attaches to their smartphone to take photos of skin lesions for teledermatology, instructions on skin self-examination from the ASICA skin checker App, text and email reminders to perform self-examination every 2 months, an educational booklet 'Your guide to early melanoma', and scheduled visits to their clinician as required.
Active Comparator: Clinician-led surveillance - Participants receive an educational booklet 'Your guide to early melanoma' and scheduled visits to their clinician as required.
Treatment: Devices: Patient-led surveillance
Usual care plus reminders, ASICA instructional videos, a mobile dermatoscope, an app that facilitates store-and-forward teledermatology, and fast-tracked unscheduled clinic visits.
Behaviour: Clinician-led surveillance
Usual care (scheduled clinician visits)
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Intervention code [1]
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Treatment: Devices
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Intervention code [2]
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Behaviour
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The Percentage of Eligible and Contacted Patients Who Were Randomised Into the Trial
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Assessment method [1]
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For the primary outcome (composite primary outcome), the percentage was estimated using the number of patients screened who were eligible and contacted as the denominator and the number of patients who were randomised as the numerator.
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Timepoint [1]
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Baseline
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Secondary outcome [1]
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Adherence to Recommended Total Body Skin Self Examinations Practice: Frequency of Skin Self-examinations.
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Assessment method [1]
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Adherence to the national guidelines recommendations on skin self-examination frequency was measured via a patient questionnaire asking participants how often they performed a complete self-examination of their skin over the previous 6 months.
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Timepoint [1]
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Baseline, at 6 months
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Secondary outcome [2]
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Adherence to Recommended Total Body Skin Self Examinations Practice: Thoroughness of Skin Self-examination
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Assessment method [2]
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To calculate this variable, the percentage of participants who examined the whole body skin surface during skin self-examination was calculated. Participants were asked if they performed a complete examination of their skin including hard to see areas such as neck/scalp, bottom and feet.
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Timepoint [2]
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Baseline, 6 months
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Secondary outcome [3]
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Successful Submission of Dermoscopic Images for Teledermatology (Intervention Group Only)
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Assessment method [3]
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The number of times images were successfully submitted for teledermatologist review over the six-month intervention period by intervention group participants (count and percentage presented).
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Timepoint [3]
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At 6 months
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Secondary outcome [4]
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Number of Skin Clinic Visits Attended (Scheduled and Unscheduled)
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Assessment method [4]
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Total number of clinic visits attended (both scheduled and unscheduled)
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Timepoint [4]
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During the 12 months after randomisation
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Secondary outcome [5]
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Number of Skin Lesions Surgically Excised
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Assessment method [5]
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This outcome has been assessed by conducting a review of medical records such as histopathology reports and doctor's letters. Descriptive statistics such as median with Interquartile Range of total number of skin lesions surgically excised during 12 months after randomisation were calculated.
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Timepoint [5]
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During the 12 months after randomisation
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Secondary outcome [6]
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New Subsequent Primary or Recurrent Melanoma Diagnoses
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Assessment method [6]
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This outcome was assessed by conducting a review of medical records at the clinic. Melanoma stage was classified according to the 8th American Joint Committee on Cancer. Stages range from 0 where the melanoma is confined to the epidermis (melanoma in situ) through to stage IV where the melanoma has spread to distant organs or lymph nodes.
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Timepoint [6]
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12 months
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Secondary outcome [7]
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New Melanoma Diagnoses Prompted by Visit Type
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Assessment method [7]
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New melanoma diagnoses prompted by visit type such as unscheduled visits and scheduled visits were calculated.
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Timepoint [7]
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During 12 months after randomisation
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Secondary outcome [8]
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General Anxiety, Stress, and Depression Measured Using the Depression Anxiety Stress Scales-21
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Assessment method [8]
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This outcome has been measured using the short version of the Depression Anxiety and Stress Scales (DASS-21). The DASS-21 is a set of three 7-item self-report scales designed to measure the emotional states of depression, anxiety and stress. The depression scale measures dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest/involvement, anhedonia and inertia. The anxiety scale measures autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. The stress scale assesses difficulty relaxing, nervous arousal, and feeling irritable and impatient. Each scale ranges from "Did not apply to me" (0) to "Applied to me very much or most of the time" (3). A higher value is considered a worse outcome.
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Timepoint [8]
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Baseline, 6 months
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Eligibility
Key inclusion criteria
- Patients treated for stage 0/I/II melanoma and are attending regular melanoma
follow-up as indicated by scheduled visit within next 12 months in clinic patient
booking system and
- Are able to self-examine;
- Have a suitable study partner (spouse, partner, family member, friend);
- Have a smart phone with access to Wifi / email / SMS text messaging;
- Are able to give informed consent ;
- Have sufficient English language skills to read the materials and complete the
questionnaires;
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Unable to perform self-examination
- No partner or friend to help with self-examination
- Do not have access to a smart phone with Wifi/email/SMS text messaging
- With a known past or current diagnosis of cognitive impairment
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
17/02/2020
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Sample size
Target
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Accrual to date
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Final
100
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Newcastle Skin Check - Newcastle
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Recruitment hospital [2]
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Melanoma Institute Australia - North Sydney
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Recruitment hospital [3]
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Royal Prince Alfred Hospital - Sydney
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Recruitment postcode(s) [1]
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2290 - Newcastle
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Recruitment postcode(s) [2]
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2060 - North Sydney
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Recruitment postcode(s) [3]
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2050 - Sydney
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Sydney
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Melanoma and Skin Cancer Trials Limited
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03581188
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Katy Bell, A/Prof
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Address
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University of Sydney
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03581188
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