Patient-led Surveillance Compared to Clinician-led Surveillance in People Treated for Localised Melanoma.

NCT03581188 | Completed Results DMC

• 2 other identifiers: ANZMTG 02.17ACTRN12616001716459
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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.

Conditions

Melanoma (Skin)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Adherence to Recommended Total Body Skin Self Examinations Practice: Frequency of Skin Self-examinations.

  Baseline, at 6 months

• Adherence to Recommended Total Body Skin Self Examinations Practice: Thoroughness of Skin Self-examination

  Baseline, 6 months

• Successful Submission of Dermoscopic Images for Teledermatology (Intervention Group Only)

  At 6 months

• Number of Skin Clinic Visits Attended (Scheduled and Unscheduled)

  During the 12 months after randomisation

• Number of Skin Lesions Surgically Excised

  During the 12 months after randomisation

Study Arms (2)

Patient-led surveillance

EXPERIMENTAL

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

Clinician-led surveillance

ACTIVE COMPARATOR

Participants receive an educational booklet 'Your guide to early melanoma' and scheduled visits to their clinician as required.

Behavioral: Clinician-led surveillance

Interventions

Patient-led surveillance DEVICE

Usual care plus reminders, ASICA instructional videos, a mobile dermatoscope, an app that facilitates store-and-forward teledermatology, and fast-tracked unscheduled clinic visits.

Patient-led surveillance

Clinician-led surveillance BEHAVIORAL

Usual care (scheduled clinician visits)

Clinician-led surveillance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sydney: lead
• Melanoma and Skin Cancer Trials Limited: collaborator

Study Sites (3)

Newcastle Skin Check

Newcastle, New South Wales, 2290, Australia

Location

Melanoma Institute Australia

North Sydney, New South Wales, 2060, Australia

Location

Royal Prince Alfred Hospital

Sydney, New South Wales, 2050, Australia

Location

Related Publications (1)

• Drabarek D, Ackermann D, Medcalf E, Bell KJL. Acceptability of a Hypothetical Reduction in Routinely Scheduled Clinic Visits Among Patients With History of a Localized Melanoma (MEL-SELF): Pilot Randomized Clinical Trial. JMIR Dermatol. 2023 Jun 26;6:e45865. doi: 10.2196/45865.

  PMID: 37632976 DERIVED

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Associate Professor Katy Bell
• Organization: The University of Sydney, Australia

katy.bell@sydney.edu.au

+61 415 764 321

Study Officials

• Katy Bell, A/Prof

  University of Sydney

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2018
• First Posted: July 10, 2018
• Study Start: November 1, 2018
• Primary Completion: February 17, 2020
• Study Completion: February 17, 2020
• Last Updated: August 1, 2023
• Results First Posted: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3)