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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)

Primary Purpose

Patients at Risk for Melanoma

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Taking photographs of suspicious lesions with his smartphone and sending them to the dermatologist
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Patients at Risk for Melanoma focused on measuring Public Health, General Medicine, Dermatology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
"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.

Full Information

First Posted
April 28, 2017
Last Updated
April 26, 2019
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03137511
Brief 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
Acronym
OASE Melanome
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
May 23, 2017 (Actual)
Primary Completion Date
November 28, 2018 (Actual)
Study Completion Date
November 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients at Risk for Melanoma
Keywords
Public Health, General Medicine, Dermatology

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cluster randomization of MGs corresponding to their exercise sites
Masking
None (Open Label)
Allocation
Randomized
Enrollment
270 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Taking photographs of suspicious lesions with his smartphone and sending them to the dermatologist
Intervention Description
Taking photographs of suspicious lesions with his smartphone and sending them to the dermatologist
Primary Outcome Measure Information:
Title
Time limit for consultation general practitioner / dermatologist, patients having a sufficiently suspicious lesion of melanoma
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Time limit for consultation general practitioner / dermatologist, patients NOT having a sufficiently suspicious lesion of melanoma
Description
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
Time Frame
12 months
Title
"Non-observing" patients between the 2 randomization groups
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
University Hospital
City
Nantes
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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