Comparison of Two Strategies for Counseling Skin Examination and Sun Protection in First-degree Relatives of Patients With Melanoma (FADEMELA)

December 23, 2025 updated by: University Hospital, Tours

Written Advice to Improve Compliance With Early Detection of Melanoma in First-degree Relatives: a Multicenter, Cluster-randomized Intervention Trial to Evaluate the Impact of Specific Incentives and Study Psychological Determinants of Early Melanoma Detection Behavior in First-degree Relatives

First-degree relatives of patients with melanoma have a greater risk of developing melanoma. Patients are advised orally to inform their first-degree relatives that they should protect their skin from UV radiation and ask for a skin examination from a general practitioner or dermatologist. The study will evaluate the effectiveness of a written sheet in addition to the usual oral counselling to increase acceptance of skin examination by the first-degree relatives. If effective, written counselling provided to the patient for relatives should be recommended and generalized.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Melanoma (MM) is a common cancer affecting 11,000 new cases per year in France and the incidence has tripled in 30 years. It now includes young people, and is responsible for 1600 deaths /year in France. Greater tumor thickness and delayed diagnosis are associated with higher mortality. Prevention and early detection on a large scale in the general population are effective but expensive. First-degree relatives have a greater risk of developing MM. A study carried out in the USA found that a biennial consultation is justified and cost-effective in first-degree relatives of MM patients. The best way to deliver the message of sun protection and screening by a dermatologist, and the reality of behavioural changes induced by counseling and the psychological determinants of adherence to medical skin examination are not fully understood.

A pilot study performed in our center suggested the value of a short written advice provided for participants to give to their relatives to promote sun protection and medical skin examination. The participants reported a significant increase in interest in medical skin examination by their relatives (p=0.006), but the investigators do not know whether the relatives really consulted for examination.

The aim of the multicenter cluster-randomized study is to demonstrate that a higher ratio of relatives will in fact consult their GP or dermatologist for skin examination in the centers randomized to the intervention arm, i.e advice leaflet and usual oral counselling, compared to the centers randomized in the control arm, i.e. usual oral counselling. Participants and their relatives in the intervention group will be asked to undergo psychological tests to identify potential barriers to skin examination and sun protection.

If effective, the investigators expect to improve the written information and to generalize its distribution at national level.

Study Type

Interventional

Enrollment (Actual)

420

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49033
        • CHU - ANGERS , Service de Dermatologie
      • Brest, France, 29000
        • CHRU BREST Hôpital du Morvan, Institut de Cancérologie et d'Hématologie
      • La Rochelle, France, 17000
        • GH La Rochelle Ré Aunis-Service de Dermatologie
      • Le Mans, France, 72000
        • CH Le Mans
      • Nantes, France, 44000
        • CHU NANTES, Service de Dermatologie
      • Poitiers, France, 86000
        • CHU-Poitiers _LA MILETRIE POLE MEDIPOOL-DERMATO-ALLERGOLOGIE
      • Rennes, France, 35000
        • CHU -RENNES -Service de Dermatologie-CHU Pontchaillou
      • Rennes, France, 35042
        • Centre Eugène Marquis -Service d'Oncologie médicale
      • Tours, France, 37044
        • University Hospital of Tours, Service de Dermatologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

For Patients:

  • Personal history of Stage 0 through IIB melanoma
  • At maximum of 12 weeks after surgical treatment of Stage 0 through IIA melanoma
  • Have at least one first-degree relative
  • Speaking and reading French
  • Affiliated to the French Health Insurance system
  • Signed non-opposition form at the 1 year consultation

For 1st degree relatives:

  • To be 1st degree related to a patient with melanoma
  • Speaking and reading French
  • 1st degree relatives informed by patients and agreeing to fill out the psychological questionnaires and to the use of their personal data by the investigators.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control

Education and counseling as commonly delivered to the patients in clinical practice.

Brief oral counseling to the patient focusing on sun protection, self-skin examination, medical skin examination, increased risk of melanoma for their first-degree relatives, who should be informed orally by the patients to protect themselves from UV radiation, perform self-skin examination and ask their GP or dermatologist to perform annual skin examination
Behavioral: In-person counseling

In-person counseling

Sun protection

Behavioral: Medical skin screening
Medical skin screening
Experimental: Intervention group

Education and counseling as commonly delivered to the patients in clinical practice and written advice for their first-degree relatives.

In addition to oral counseling to the patient, written advice will be provided to patients for their relatives focusing on sun protection, self-skin examination, medical skin examination, increased risk of melanoma for first-degree relatives, who should also be informed orally by the patients to protect themselves from UV radiation, perform self-skin examination and ask their GP or dermatologist to perform annual skin examinations.
Behavioral: In-person counseling

In-person counseling

Sun protection

Behavioral: Medical skin screening
Medical skin screening
Behavioral: Written advice
Written advice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Consulting general practitioner or dermatologist
Time Frame: 1 year
The number of relatives who will have consulted a dermatologist or a general practitioner to perform whole body skin examination
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-skin examination reported by the relatives
Time Frame: 1 year
The number of relatives who declare to have performed Self-skin examination.
1 year
Sun protection behaviors reported by the relatives
Time Frame: 1 year
Sun protection behaviours reported by the relatives and assessed by a questionnaire
1 year
Barriers to skin examination identified from psychological questionnaires in patients and their relatives
Time Frame: 1 year
Psychological barriers of patients and their relatives to skin examination evaluated with several questionnaires and scales.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Collaborators

Institut national de la santé et de la recherche médicale, CIC 1415, TOURS
Institut national de la santé et de la recherche médicale, U930,TOURS
Institut d'Enseignement à Distance,University Paris - 8

Investigators

  • Study Director: Laurent MACHET, MD-PHD, University Hospital, Tours

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2017

Primary Completion (Actual)

April 26, 2019

Study Completion (Actual)

July 10, 2019

Study Registration Dates

First Submitted

July 28, 2016

First Submitted That Met QC Criteria

September 26, 2016

First Posted (Estimated)

September 28, 2016

Study Record Updates

Last Update Posted (Estimated)

December 30, 2025

Last Update Submitted That Met QC Criteria

December 23, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCA14/LM-FADEMELA
  • 2016-A00186-45 (Registry Identifier: RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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