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

Patients at Risk for Melanoma Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03137511
• Other study ID #: RC16_0033
• Status: Completed
• Phase: N/A
• Start date: May 23, 2017
• Est. completion date: November 28, 2018

Study information

• Verified date: April 2019
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: November 28, 2018
• Est. primary completion date: November 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma
• Patients at Risk for Melanoma

Intervention

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

Locations

Country	Name	City	State
France	University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	"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