Cutaneous MelanomaMelaMEdNCT07757386
MelaMEd Online Training for General Practitioners to Improve Melanoma Detection and Management
A study testing MelaMEd Online Training Program in people with Cutaneous Melanoma, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 10 sites in Italy.
Trial summary
The goal of this trial was to learn whether the MelaMEd online training program could improve doctors' skills in the early detection and management of melanoma, the most aggressive type of skin cancer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cutaneous Melanoma
- What is being tested?
- MelaMEd Online Training Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,531 participants
- Where
- 10 sitesItaly
- Study dates
- 1 Jun 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Licensed general practitioners, general practitioners in training, or pediatricians working in the healthcare system areas served by participating Italian Melanoma Intergroup centers.
- Voluntary agreement to participate in the study evaluation.
- Confirmation that the participant had read and understood the information on personal data processing.
- Authorization for the processing of personal data in accordance with European Union Regulation 2016/679.
Who cannot join
- No formal exclusion criteria were specified.
- Individuals who did not authorize the processing of their personal data could access the MelaMEd educational course and platform but were not included in the evaluation of the training program.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Italy10 sites
Dermatology and Dermosurgery Unit, San Giuseppe Moscati Hospital
Avellino, Campania, 83100
Unità di Dermatologia, ASST Papa Giovanni XXIII Ospedale di Bergamo, Bergamo
Bergamo, Lombardy, 24127
Divisione di Dermatologia Cesena/Forlì AUSL Romagna e Dipartimento di Medicina e Chirurgia, Università di Bologna
Cesena, Emilia-Romagna, 47521
Section of Dermatology and Infectious Diseases, University of Ferrara
Ferrara, Emilia-Romagna, 44121
Unità di Dermatologia, Azienda Socio Sanitaria Territoriale (ASST) Lecco, Ospedale Alessandro Manzoni, Lecco
Lecco, Lombardy, 23900
SC Dermatologia, Dipartimento di Medicina e Chirurgia, Università di Parma, Parma
Parma, Emilia-Romagna, 43126
Clinica Dermatologica, Fondazione IRCCS Policlinico San Matteo Pavia, Università degli Studi di Pavia, Pavia
Pavia, Lombardy, 27100
Istituto Dermopatico dell'Immacolata (IDI)-IRCCS, Roma
Rome, Lazio, 00167
Dipartimento di Medicina, Chirurgia e Farmacia, Università di Sassari, Sassari
Sassari, Sardinia, 07100
Melanoma Skin Centre, ASST dei Sette Laghi, Ospedale di Circolo e Fondazione Macchi
Varese, Lombardy, 21100
About this study
Official title: Evaluation of a Training Course for General Practitioners Within the Melanoma Multimedia Education Programme of the Italian Melanoma Intergroup: A Study Protocol
The goal of this trial was to learn whether the MelaMEd online training program could improve doctors' skills in the early detection and management of melanoma, the most aggressive type of skin cancer. The participants were primary care physicians, including general practitioners, general practice trainees, and pediatricians.
The main questions were:
Read more
Did the training improve doctors' ability to identify skin lesions that might be melanoma? Did the training improve their knowledge of melanoma prevention, diagnosis, and management? Did the training help doctors make better decisions about referring patients to a dermatologist?
Participants first completed an online questionnaire. It included questions about melanoma and images of skin lesions. Participants then completed the MelaMEd online training course.
After the training, participants completed a second questionnaire with the same main questions. They also answered questions about their confidence in managing melanoma and their experience with the course.
Researchers compared each participant's answers before and after the training. There was no separate comparison group.
Read the detailed description
MelaMEd, which stands for Melanoma Multimedia Education, is an online educational program developed by the Italian Melanoma Intergroup. The program was designed mainly for general practitioners and other primary care physicians involved in melanoma prevention, early detection, and referral.
The educational intervention consisted of a free asynchronous e-learning course titled "Early Diagnosis and Management of the Therapeutic Diagnostic Pathway of Melanoma." The course included video lessons, clinical images, interactive cases, and switches between video lectures and the IMI MelaMEd multimedia atlas on the MelaMEd Platform.
The educational content covered melanoma risk factors, sun exposure and sun protection, skin examination, clinical recognition rules, differential diagnosis, referral decisions, histopathology, staging, and treatment. Clinical recognition rules included the ABCDE rule, the EFG rule, and the "Ugly Duckling" sign.
The study used a prospective, single-group, before-and-after design. Eligible participants were general practitioners, general practitioners in training, and pediatricians working in the healthcare areas of participating Italian Melanoma Intergroup centers. Participation was voluntary.
Before the training, participants completed an online questionnaire. The questionnaire included seven multiple-choice questions about melanoma knowledge and 10 images of skin lesions. For each image, participants were asked to:
classify the lesion as benign or malignant; select the most likely diagnosis; decide whether referral to a dermatologist was appropriate.
After completing the training, participants received a post-training questionnaire. It repeated the main knowledge and clinical case questions. It also included questions about confidence in melanoma prevention, skin self-examination counseling, recognition of suspicious lesions, and satisfaction with the course.
Each participant received a numerical code that allowed the researchers to match pre-training and post-training answers. The main outcomes were changes in melanoma knowledge, diagnostic performance, and referral decisions. Additional outcomes included changes in self-reported confidence and participants' views on the usefulness and usability of the educational program.
Paired pre-training and post-training responses were compared using statistical methods for matched data.
- Conditions
- Cutaneous Melanoma
- Being tested
- MelaMEd Online Training Program
- Keywords
- MelaMEd, General Practitioners, Primary Care Physicians, Medical Education, E-Learning, Melanoma Detection, Diagnostic Accuracy, Skin Lesion Triage, Continuing Medical Education
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelaMEd Online Training ProgramBehavioural
The intervention was a free, self-paced asynchronous e-learning course titled "Early Diagnosis and Management of the Therapeutic Diagnostic Pathway of Melanoma," integrated with the MelaMEd multimedia platform. The course included video lectures and interactive clinical cases covering melanoma risk factors, sun exposure and photoprotection, skin examination, clinical recognition rules such as the ABCDE rule, the EFG rule, and the "Ugly Duckling" sign, histopathological diagnosis, surgical and medical treatment, staging, prognosis, and referral decision-making. The linked MelaMEd platform provided clinical, dermoscopic, and histological images, interactive educational resources, and access to guidelines and scientific literature.
| Study group | Role | What they receive |
|---|---|---|
| MelaMEd Online Training | Experimental | Participants received the MelaMEd asynchronous online educational program, including video lessons, interactive clinical cases, and access to the MelaMEd multimedia platform. Knowledge of melanoma, diagnostic performance, referral decisions, and self-reported confidence were assessed before and after the training. No control or comparison arm was included. Receives: Behavioral: MelaMEd Online Training Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Melanoma Knowledge After MelaMEd Training
Melanoma knowledge was assessed using seven multiple-choice questions covering ultraviolet radiation, complete skin examination, the ABCDE rule, the EFG rule, the Ugly Duckling sign, dermoscopy, and Breslow thickness. For each question, the percentage of participants selecting the correct answer was calculated before and after training using matched responses. Higher percentages indicate better melanoma knowledge.
Measured: Pre-training baseline and post-training assessment within 10 days of completion of the online course
Change in Diagnostic Performance Across 10 Skin Lesion Cases
Diagnostic performance was assessed using 10 clinical images of melanocytic and non-melanocytic skin lesions. For each case, participants classified the lesion as benign or malignant and selected the most likely diagnosis from four options. The percentages of correct benign or malignant classifications and correct diagnoses were calculated before and after training using matched responses. Pooled sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy were also calculated. Higher values indicate better diagnostic performance.
Measured: Pre-training baseline and post-training assessment within 10 days of completion of the online course
Change in Dermatology Referral Decisions for Skin Lesions
Using the same 10 clinical cases, participants indicated whether the person should be referred to a dermatologist for specialist assessment and possible excision. For each case, the percentage of participants selecting referral was calculated before and after training using matched responses. Changes were interpreted according to the reference diagnosis, with the aim of increasing referral of malignant lesions and reducing unnecessary referral of benign lesions.
Measured: Pre-training baseline and post-training assessment within 10 days of completion of the online course
Secondary outcomes (2)
Change in Self-Reported Confidence in Melanoma Prevention and Detection
Participants rated their confidence in three domains: counseling on melanoma prevention, guiding patients in skin self-examination, and recognizing lesions suspicious for melanoma. Each domain was rated on a 5-point Likert scale from 1, not confident, to 5, very confident. Pre-training and post-training ratings were compared using matched responses. Higher scores indicate greater confidence.
Measured: Pre-training baseline and post-training assessment within 10 days of completion of the online course
Participant Satisfaction and Perceived Usefulness of the MelaMEd Training
After training, participants completed five items assessing the perceived usefulness, usability, and clinical value of the MelaMEd program. Each item used a 5-point Likert scale from 1, strongly disagree, to 5, strongly agree. Responses were summarized as numbers and percentages. Higher scores indicate a more favorable evaluation of the training.
Measured: Post-training assessment within 10 days of completion of the online course
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start1 Jun 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous MelanomaStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants were assigned to the same MelaMEd educational intervention. The study used a single-group before-and-after design, with no control or comparison arm. Training effectiveness was assessed by comparing available paired responses to questionnaires completed before and after the intervention.
- Masking
- None (open label)
- Enrolment
- 1,531 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
- Sponsor type
- University, hospital or other
- Collaborators
- Intergruppo Melanoma Italiano
- Responsible party
- Principal investigator, Federica Zamagni, Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
- Investigators
- Ignazio Stanganelli, MD, Principal investigator, Skin Cancer Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07757386
- Sponsor's protocol ID
- L4P3037
- Other IDs
- wfn.27L4
- Acronym
- MelaMEd
- Status last verified
- Aug 2026
- First submitted
- 16 Jul 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant-level data underlying the tables and analyses reported in the primary publication will be shared. The dataset will include the participant-level professional characteristics and questionnaire responses used in the reported analyses. Direct identifiers, contact details, workplace information, and any variables that could reasonably permit participant re-identification will not be shared. The final dataset and accompanying documentation will be deposited in the authors' institutional Zenodo repository after acceptance of the primary manuscript. The repository DOI will be added to the study record when available.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Training Course for General Practitioners Within the Melanoma Multimedia Education Programme of the Italian Melanoma Intergroup: A Study Protocol
- ClinicalTrials.gov ID
- NCT07757386
- Acronym / sponsor ID
- MelaMEd / L4P3037
- Conditions
- Cutaneous Melanoma
- Keywords
- MelaMEd, General Practitioners, Primary Care Physicians, Medical Education, E-Learning, Melanoma Detection, Diagnostic Accuracy, Skin Lesion Triage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,531 participants (actual)
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCSUniversity, hospital or other
- Collaborators
- Intergruppo Melanoma Italiano
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this trial was to learn whether the MelaMEd online training program could improve doctors' skills in the early detection and management of melanoma, the most aggressive type of skin cancer. The participants were primary care physicians, including general practitioners, general practice trainees, and pediatricians.
The main questions were:
Did the training improve doctors' ability to identify skin lesions that might be melanoma? Did the training improve their knowledge of melanoma prevention, diagnosis, and management? Did the training help doctors make better decisions about referring patients to a dermatologist?
Participants first completed an online questionnaire. It included questions about melanoma and images of skin lesions. Participants then completed the MelaMEd online training course.
After the training, participants completed a second questionnaire with the same main questions. They also answered questions about their confidence in managing melanoma and their experience with the course.
Researchers compared each participant's answers before and after the training. There was no separate comparison group.
Detailed description
MelaMEd, which stands for Melanoma Multimedia Education, is an online educational program developed by the Italian Melanoma Intergroup. The program was designed mainly for general practitioners and other primary care physicians involved in melanoma prevention, early detection, and referral.
The educational intervention consisted of a free asynchronous e-learning course titled "Early Diagnosis and Management of the Therapeutic Diagnostic Pathway of Melanoma." The course included video lessons, clinical images, interactive cases, and switches between video lectures and the IMI MelaMEd multimedia atlas on the MelaMEd Platform.
The educational content covered melanoma risk factors, sun exposure and sun protection, skin examination, clinical recognition rules, differential diagnosis, referral decisions, histopathology, staging, and treatment. Clinical recognition rules included the ABCDE rule, the EFG rule, and the "Ugly Duckling" sign.
The study used a prospective, single-group, before-and-after design. Eligible participants were general practitioners, general practitioners in training, and pediatricians working in the healthcare areas of participating Italian Melanoma Intergroup centers. Participation was voluntary.
Before the training, participants completed an online questionnaire. The questionnaire included seven multiple-choice questions about melanoma knowledge and 10 images of skin lesions. For each image, participants were asked to:
classify the lesion as benign or malignant; select the most likely diagnosis; decide whether referral to a dermatologist was appropriate.
After completing the training, participants received a post-training questionnaire. It repeated the main knowledge and clinical case questions. It also included questions about confidence in melanoma prevention, skin self-examination counseling, recognition of suspicious lesions, and satisfaction with the course.
Each participant received a numerical code that allowed the researchers to match pre-training and post-training answers. The main outcomes were changes in melanoma knowledge, diagnostic performance, and referral decisions. Additional outcomes included changes in self-reported confidence and participants' views on the usefulness and usability of the educational program.
Paired pre-training and post-training responses were compared using statistical methods for matched data.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants were assigned to the same MelaMEd educational intervention. The study used a single-group before-and-after design, with no control or comparison arm. Training effectiveness was assessed by comparing available paired responses to questionnaires completed before and after the intervention.
| Arm | Type | Receives |
|---|---|---|
| MelaMEd Online Training | Experimental | Behavioral: MelaMEd Online Training ProgramParticipants received the MelaMEd asynchronous online educational program, including video lessons, interactive clinical cases, and access to the MelaMEd multimedia platform. Knowledge of melanoma, diagnostic performance, referral decisions, and self-reported confidence were assessed before and after the training. No control or comparison arm was included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Licensed general practitioners, general practitioners in training, or pediatricians working in the healthcare system areas served by participating Italian Melanoma Intergroup centers.
- Voluntary agreement to participate in the study evaluation.
- Confirmation that the participant had read and understood the information on personal data processing.
- Authorization for the processing of personal data in accordance with European Union Regulation 2016/679.
Key exclusion criteria (2 listed)
- No formal exclusion criteria were specified.
- Individuals who did not authorize the processing of their personal data could access the MelaMEd educational course and platform but were not included in the evaluation of the training program.
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 |
|---|---|---|
| MelaMEd Online Training ProgramThe intervention was a free, self-paced asynchronous e-learning course titled "Early Diagnosis and Management of the Therapeutic Diagnostic Pathway of Melanoma," integrated with the MelaMEd multimedia platform. The course included video lectures and interactive clinical cases covering melanoma risk factors, sun exposure and photoprotection, skin examination, clinical recognition rules such as the ABCDE rule, the EFG rule, and the "Ugly Duckling" sign, histopathological diagnosis, surgical and medical treatment, staging, prognosis, and referral decision-making. The linked MelaMEd platform provided clinical, dermoscopic, and histological images, interactive educational resources, and access to guidelines and scientific literature. | Behavioural | MelaMEd Online Training |
Primary outcome
Change in Melanoma Knowledge After MelaMEd Training
Time frame: Pre-training baseline and post-training assessment within 10 days of completion of the online course
Melanoma knowledge was assessed using seven multiple-choice questions covering ultraviolet radiation, complete skin examination, the ABCDE rule, the EFG rule, the Ugly Duckling sign, dermoscopy, and Breslow thickness. For each question, the percentage of participants selecting the correct answer was calculated before and after training using matched responses. Higher percentages indicate better melanoma knowledge.
Change in Diagnostic Performance Across 10 Skin Lesion Cases
Time frame: Pre-training baseline and post-training assessment within 10 days of completion of the online course
Diagnostic performance was assessed using 10 clinical images of melanocytic and non-melanocytic skin lesions. For each case, participants classified the lesion as benign or malignant and selected the most likely diagnosis from four options. The percentages of correct benign or malignant classifications and correct diagnoses were calculated before and after training using matched responses. Pooled sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy were also calculated. Higher values indicate better diagnostic performance.
Change in Dermatology Referral Decisions for Skin Lesions
Time frame: Pre-training baseline and post-training assessment within 10 days of completion of the online course
Using the same 10 clinical cases, participants indicated whether the person should be referred to a dermatologist for specialist assessment and possible excision. For each case, the percentage of participants selecting referral was calculated before and after training using matched responses. Changes were interpreted according to the reference diagnosis, with the aim of increasing referral of malignant lesions and reducing unnecessary referral of benign lesions.
2 secondary outcomes
Change in Self-Reported Confidence in Melanoma Prevention and Detection
Time frame: Pre-training baseline and post-training assessment within 10 days of completion of the online course
Participant Satisfaction and Perceived Usefulness of the MelaMEd Training
Time frame: Post-training assessment within 10 days of completion of the online course
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Official MelaMEd (Melanoma Multimedia Education) educational platform used in the study, providing multimedia resources on melanoma prevention, early detection, diagnosis, management, and referral.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant-level data underlying the tables and analyses reported in the primary publication will be shared. The dataset will include the participant-level professional characteristics and questionnaire responses used in the reported analyses. Direct identifiers, contact details, workplace information, and any variables that could reasonably permit participant re-identification will not be shared. The final dataset and accompanying documentation will be deposited in the authors' institutional Zenodo repository after acceptance of the primary manuscript. The repository DOI will be added to the study record when available.
Related trials for Cutaneous Melanoma
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
RecruitingPhase 1
Phase 1 Study of PF-08046033 in Advanced Solid Tumors
Non-Small-Cell Lung, Esophageal Cancer
RecruitingPhase 2
BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Active, not recruitingPhase 2
A Study to Compare the Administration of Pembrolizumab After Surgery Versus Administration Both Before and After Surgery for High-Risk Melanoma
Acral Lentiginous Melanoma, Clinical Stage III Cutaneous Melanoma AJCC v8
RecruitingEarly Phase 1
177Lu-anti-PD-L1 sdAb in Metastatic Solid Tumors
PDL1 Gene Mutation, Non Small Cell Lung Cancer
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.
Ignazio Stanganelli, MD principal investigator
Skin Cancer Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MelaMEd Online Training Program in people with Cutaneous Melanoma, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 10 sites in Italy.
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 4 inclusion and 2 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 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Melanoma Knowledge After MelaMEd Training (time frame: Pre-training baseline and post-training assessment within 10 days of completion of the online course). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.