Patient-led Surveillance Compared to Clinician-led Surveillance in People Treated for Localised Melanoma. (MEL-SELF)

A Randomised Controlled Pilot Trial of Patient-led Surveillance Compared to Clinician-led Surveillance in People Treated for Localised Melanoma.

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

Study Overview

• Status: Completed
• Conditions: Melanoma (Skin)
• Intervention / Treatment: Device: Patient-led surveillance; Behavioral: Clinician-led surveillance

Detailed Description

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

People who are found to be eligible and who consent to participate will be randomised (allocated by chance) to the intervention or usual care in a 1:1 ratio. Usual care group will receive an educational booklet on early melanoma and the usual number of routine clinic visits. In addition to usual care, participants allocated to the intervention group will be required to download a skin checker App to their smartphone and will use a mobile dermatoscope to perform total body skin self-examinations every 2 months for 6 months in total. Email and SMS reminders will also be sent every two months to participants in the intervention group. Participants will be documented on how well they are able to perform a self skin examination, their levels of melanoma-related anxiety, the number of skin lesions biopsied or removed, and the costs of follow-up to the participant and to the healthcare system.

Frequent follow-up of localised melanoma is time and resource intensive, and has not shown improved outcomes. This pilot study will provide evidence on which model is best for follow-up care after treatment for localised melanoma.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Newcastle, New South Wales, Australia, 2290
      • Newcastle Skin Check
    • North Sydney, New South Wales, Australia, 2060
      • Melanoma Institute Australia
    • Sydney, New South Wales, Australia, 2050
      • Royal Prince Alfred Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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;

Exclusion Criteria:

• Unable to perform self-examination
• No partner or friend to help with self-examination
• Do not have access to a smart phone with Wifi/email/SMS text messaging
• With a known past or current diagnosis of cognitive impairment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: 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.
Active Comparator: Clinician-led surveillance; Participants receive an educational booklet 'Your guide to early melanoma' and scheduled visits to their clinician as required.	Behavioral: Clinician-led surveillance; Usual care (scheduled clinician visits)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Percentage of Eligible and Contacted Patients Who Were Randomised Into the Trial	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.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to Recommended Total Body Skin Self Examinations Practice: Frequency of Skin Self-examinations.	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.	Baseline, at 6 months
Adherence to Recommended Total Body Skin Self Examinations Practice: Thoroughness of Skin Self-examination	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.	Baseline, 6 months
Successful Submission of Dermoscopic Images for Teledermatology (Intervention Group Only)	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).	At 6 months
Number of Skin Clinic Visits Attended (Scheduled and Unscheduled)	Total number of clinic visits attended (both scheduled and unscheduled)	During the 12 months after randomisation
Number of Skin Lesions Surgically Excised	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.	During the 12 months after randomisation
New Subsequent Primary or Recurrent Melanoma Diagnoses	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.	12 months
New Melanoma Diagnoses Prompted by Visit Type	New melanoma diagnoses prompted by visit type such as unscheduled visits and scheduled visits were calculated.	During 12 months after randomisation
General Anxiety, Stress, and Depression Measured Using the Depression Anxiety Stress Scales-21	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.	Baseline, 6 months

Collaborators and Investigators

• Sponsor: University of Sydney
• Collaborators: Melanoma and Skin Cancer Trials Limited
• Investigators: Principal Investigator: Katy Bell, A/Prof, University of Sydney

Publications and helpful links

Helpful Links

• Published paper from this trial

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): February 17, 2020
• Study Completion (Actual): February 17, 2020

Study Registration Dates

• First Submitted: June 18, 2018
• First Submitted That Met QC Criteria: July 8, 2018
• First Posted (Actual): July 10, 2018

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: ANZMTG 02.17; ACTRN12616001716459 (Registry Identifier: ANZCTR)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No