Melanoma (Skin)MEL-SELFNCT03581188
Patient-led Surveillance Compared to Clinician-led Surveillance in People Treated for Localised Melanoma.
A study testing Patient-led surveillance and Clinician-led surveillance in people with Melanoma (Skin), run by University of Sydney at 3 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma (Skin)
- What is being tested?
- Patient-led surveillance and Clinician-led surveillance
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesAustralia
- Study dates
- 1 Nov 2018to 17 Feb 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Australia3 sites
Newcastle Skin Check
Newcastle, New South Wales, 2290
Melanoma Institute Australia
North Sydney, New South Wales, 2060
Royal Prince Alfred Hospital
Sydney, New South Wales, 2050
About this study
Official title: 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.
Read the 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.
- Conditions
- Melanoma (Skin)
- Being tested
- Patient-led surveillance, Clinician-led surveillance
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-led surveillanceDevice
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 surveillanceBehavioural
Usual care (scheduled clinician visits)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Clinician-led surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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).
Measured: At 6 months
Number of Skin Clinic Visits Attended (Scheduled and Unscheduled)
Total number of clinic visits attended (both scheduled and unscheduled)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start1 Nov 2018
- Primary completion17 Feb 2020
- Study completion17 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Melanoma (Skin)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sydney
- Sponsor type
- University, hospital or other
- Collaborators
- Melanoma and Skin Cancer Trials Limited
- Responsible party
- Sponsor
- Investigators
- Katy Bell, A/Prof, Principal investigator, University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03581188
- Sponsor's protocol ID
- ANZMTG 02.17
- Other IDs
- ACTRN12616001716459
- Acronym
- MEL-SELF
- Status last verified
- Jul 2023
- First submitted
- 18 Jun 2018
- Last updated
- 1 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37632976
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Pilot Trial of Patient-led Surveillance Compared to Clinician-led Surveillance in People Treated for Localised Melanoma.
- ClinicalTrials.gov ID
- NCT03581188
- Acronym / sponsor ID
- MEL-SELF / ANZMTG 02.17
- Conditions
- Melanoma (Skin)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of SydneyUniversity, hospital or other
- Collaborators
- Melanoma and Skin Cancer Trials Limited
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 17 Feb 2020 (actual)
- Study completion
- 17 Feb 2020 (actual)
- First posted
- 10 Jul 2018 (actual)
- Results
- Posted 1 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pilot study is to evaluate digitally supported skin self-examination compared to usual care in people treated for localised melanoma.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient-led surveillance | Experimental | Device: Patient-led surveillanceParticipants 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. |
| Clinician-led surveillance | Active comparator | Behavioral: Clinician-led surveillanceParticipants receive an educational booklet 'Your guide to early melanoma' and scheduled visits to their clinician as required. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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 ;
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient-led surveillanceUsual care plus reminders, ASICA instructional videos, a mobile dermatoscope, an app that facilitates store-and-forward teledermatology, and fast-tracked unscheduled clinic visits. | Device | Patient-led surveillance |
| Clinician-led surveillanceUsual care (scheduled clinician visits) | Behavioural | Clinician-led surveillance |
Primary outcome
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.
8 secondary outcomes
Adherence to Recommended Total Body Skin Self Examinations Practice: Frequency of Skin Self-examinations.
Time frame: Baseline, at 6 months
Adherence to Recommended Total Body Skin Self Examinations Practice: Thoroughness of Skin Self-examination
Time frame: Baseline, 6 months
Successful Submission of Dermoscopic Images for Teledermatology (Intervention Group Only)
Time frame: At 6 months
Number of Skin Clinic Visits Attended (Scheduled and Unscheduled)
Time frame: During the 12 months after randomisation
Number of Skin Lesions Surgically Excised
Time frame: During the 12 months after randomisation
New Subsequent Primary or Recurrent Melanoma Diagnoses
Time frame: 12 months
New Melanoma Diagnoses Prompted by Visit Type
Time frame: During 12 months after randomisation
General Anxiety, Stress, and Depression Measured Using the Depression Anxiety Stress Scales-21
Time frame: Baseline, 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37632976Drabarek 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katy Bell, A/Prof principal investigator
University of Sydney
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient-led surveillance and Clinician-led surveillance in people with Melanoma (Skin), run by University of Sydney at 3 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Percentage of Eligible and Contacted Patients Who Were Randomised Into the Trial (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03581188, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.