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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)

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ClinicalTrials.gov Identifier: NCT03137511
Recruitment Status : Recruiting
First Posted : May 2, 2017
Last Update Posted : June 8, 2017
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Patients at Risk for Melanoma Other: Taking photographs of suspicious lesions with his smartphone and sending them to the dermatologist Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 532 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cluster randomization of MGs corresponding to their exercise sites
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : May 23, 2017
Estimated Primary Completion Date : May 23, 2018
Estimated Study Completion Date : May 23, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

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.




Primary Outcome Measures :
  1. Time limit for consultation general practitioner / dermatologist, patients having a sufficiently suspicious lesion of melanoma [ Time Frame: 12 months ]

    Time limit for consultation between consultation of the general practitioner and consultation with the dermatologist, for patients:

    1. referred for a suspicious lesion of melanoma by the general practitioner,
    2. and having a sufficiently suspicious lesion of melanoma so that the dermatologist conclude at the need for excision


Secondary Outcome Measures :
  1. Time limit for consultation general practitioner / dermatologist, patients NOT having a sufficiently suspicious lesion of melanoma [ Time Frame: 12 months ]

    Time limit for consultation between consultation of the general practitioner and consultation with the dermatologist, for patients:

    1. referred for a suspicious lesion of melanoma by the general practitioner,
    2. BUT NOT having a sufficiently suspicious lesion of melanoma so that the dermatologist conclude at the need for excision

  2. "Non-observing" patients between the 2 randomization groups [ Time Frame: 12 months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03137511


Contacts
Contact: Jean-Michel NGUYEN, Doctor 02 40 41 11 29 jeanmichel.nguyen@chu-nantes.fr
Contact: Cedric RAT, Doctor 02 40 41 11 29 Cedric.Rat@univ-nantes.fr

Locations
France
University Hospital Recruiting
Nantes, France
Contact: Jean-Michel NGUYEN, Doctor       jeanmichel.nguyen@chu-nantes.fr   
Principal Investigator: Jean-Michel NGUYEN, Doctor         
Sponsors and Collaborators
Nantes University Hospital

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03137511     History of Changes
Other Study ID Numbers: RC16_0033
First Posted: May 2, 2017    Key Record Dates
Last Update Posted: June 8, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nantes University Hospital:
Public Health
General Medicine
Dermatology

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas