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Completed

NCT Number: NCT03581188

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Newcastle Skin Check, Newcastle, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Clinician-led surveillance

Behavioral

Usual care (scheduled clinician visits)

Primary outcomes

  1. The Percentage of Eligible and Contacted Patients Who Were Randomised Into the Trial

    Time frame: Baseline

    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.

Secondary outcomes

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

    Time frame: Baseline, at 6 months

    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.

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

    Time frame: Baseline, 6 months

    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.

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

    Time frame: At 6 months

    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).

  4. Number of Skin Clinic Visits Attended (Scheduled and Unscheduled)

    Time frame: During the 12 months after randomisation

    Total number of clinic visits attended (both scheduled and unscheduled)

  5. Number of Skin Lesions Surgically Excised

    Time frame: During the 12 months after randomisation

    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.

  6. New Subsequent Primary or Recurrent Melanoma Diagnoses

    Time frame: 12 months

    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.

  7. New Melanoma Diagnoses Prompted by Visit Type

    Time frame: During 12 months after randomisation

    New melanoma diagnoses prompted by visit type such as unscheduled visits and scheduled visits were calculated.

  8. General Anxiety, Stress, and Depression Measured Using the Depression Anxiety Stress Scales-21

    Time frame: Baseline, 6 months

    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.

Sponsors and collaborators

Lead sponsor

University of Sydney

Other

Collaborators

  • Melanoma and Skin Cancer Trials Limited

Registry information

Official study title

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

Acronym: MEL-SELF

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 10, 2018
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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