Optimizing Access to Care Through New Technologies: a Randomized Study Evaluating the Impact of Telephone Contact and the Sending by the General Practitioner of Suspicious Lesions Melanoma Photographs Taken With a Smartphone, on the Time Limit to the Consultation With a Dermatologist (OASE Melanome)

Early detection of melanoma showed an impact on the thickness of the lesions at the time of diagnosis. One challenge is to improve the modalities.

Decrease the rate of non-compliant patients among patients referred to the dermatologist for a suspicious lesion (patients who will never go to the consultation), and reduce the time interval between the first identification of the lesion and the excision allowing the diagnosis are major issues.

Direct contact between the general practitioner (GP) and the dermatologist would probably make it possible to shorten the care pathway of patients with lesions justifying excision.

The objective is to evaluate whether contacting the dermatologist directly by telephone and e-mailing the photograph of a suspicious melanoma lesion can significantly reduce the time required for access to the consultation for the following patients: (a) referred for a suspicious lesion of melanoma by the GP (b) and having a sufficiently suspicious lesion of melanoma so that the dermatologist conclude at the need for excision (true positives).

Expected results: The procedure should shorten the care pathway for patients with melanoma and decrease the proportion of patients who do not consult the dermatologist when they were referred ("non-observing patients").

This should facilitate the identification of thinner lesions. The benefit for the patient is then direct with a survival at 5 years higher.

In public health terms, it is expected a benefit as better optimization of resources. In a situation of shortage of professionals, access to the dermatologist should be optimized by optimizing emergency access for patients who require it.

Study Overview

• Status: Completed
• Conditions: Patients at Risk for Melanoma
• Intervention / Treatment: Other: Taking photographs of suspicious lesions with his smartphone and sending them to the dermatologist

• Study Type: Interventional
• Enrollment (Actual): 270
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nantes, France
    • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Patients:

• Consulting a general practitioner participating in the study,
• Having a suspicious cutaneous lesion of melanoma according to the MG,
• Referred to a dermatologist who agreed to participate in the study,
• > = 18 years of age, with written informed consent,
• Affiliated to a social security scheme

Exclusion Criteria:

Patients:

• Consulting a general practitioner who does not participate in the study,
• Having no suspect melanoma lesion according to MG,
• Referred to the dermatologist for symptoms or pathologies unrelated to a suspicion of melanoma
• Wishing to consult a dermatologist who refused to participate in the study,
• Refusing the transmission by mail of 2 anonymised photos,
• <18 years of age, or with no written informed consent.
• Major under tutelage, under curatorship

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: Intervention group; General practitioners will be invited to screen for melanoma as part of their regular consultations.; The MG collects relevant clinical information; The MG takes 2 photographs of the lesion with his smartphone.; The MG sends to the dermatologist by e-mail the 2 photographs of the lesion accompanied by relevant clinical information; The MG calls the secretariat of the dermatologist to record the admissibility of the mail, to give the identity and the coordinates of the patient whose photos have just been sent and to obtain an appointment.; The dermatologist proposes an appointment to the patient.	Other: Taking photographs of suspicious lesions with his smartphone and sending them to the dermatologist; Taking photographs of suspicious lesions with his smartphone and sending them to the dermatologist
No Intervention: Control group; General practitioners will be invited to screen for melanoma as part of their regular consultations. General practitioners and dermatologists continue their practice in the usual way.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time limit for consultation general practitioner / dermatologist, patients having a sufficiently suspicious lesion of melanoma	Time limit for consultation between consultation of the general practitioner and consultation with the dermatologist, for patients: referred for a suspicious lesion of melanoma by the general practitioner,; and having a sufficiently suspicious lesion of melanoma so that the dermatologist conclude at the need for excision	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time limit for consultation general practitioner / dermatologist, patients NOT having a sufficiently suspicious lesion of melanoma	Time limit for consultation between consultation of the general practitioner and consultation with the dermatologist, for patients: referred for a suspicious lesion of melanoma by the general practitioner,; BUT NOT having a sufficiently suspicious lesion of melanoma so that the dermatologist conclude at the need for excision	12 months
"Non-observing" patients between the 2 randomization groups	Proportion of "non-observing" patients between the 2 randomization groups. A non-observing patient is a patient who has not consulted a dermatologist within 12 months following the prescription of his or her GP.	12 months

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2017
• Primary Completion (Actual): November 28, 2018
• Study Completion (Actual): November 28, 2018

Study Registration Dates

• First Submitted: April 28, 2017
• First Submitted That Met QC Criteria: April 28, 2017
• First Posted (Actual): May 2, 2017

Study Record Updates

• Last Update Posted (Actual): April 29, 2019
• Last Update Submitted That Met QC Criteria: April 26, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Dermatology; Public Health; General Medicine
• 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: RC16_0033

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