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NCT Number: NCT02917473

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU - ANGERS , Service de Dermatologie, Angers, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

in-person counseling

Behavioral

In-person counseling

Sun protection

Written advice

Behavioral

Written advice

Medical skin screening

Behavioral

Medical skin screening

Primary outcomes

  1. 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

Secondary outcomes

  1. Self-skin examination reported by the relatives

    Time frame: 1 year

    The number of relatives who declare to have performed Self-skin examination.

  2. Sun protection behaviors reported by the relatives

    Time frame: 1 year

    Sun protection behaviours reported by the relatives and assessed by a questionnaire

  3. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Collaborators

  • Institut d'Enseignement à Distance,University Paris - 8
  • 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

Registry information

Official study title

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

Acronym: FADEMELA

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 28, 2016
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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