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

NCT ID: NCT02917473

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-13

Study Completion Date

2019-07-10

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Melanoma Screening

Keywords

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Medical skin examination Skin Self Examination Sun protection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type OTHER

In-person counseling

Intervention Type BEHAVIORAL

In-person counseling

Sun protection

Medical skin screening

Intervention Type BEHAVIORAL

Medical skin screening

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.

Group Type EXPERIMENTAL

In-person counseling

Intervention Type BEHAVIORAL

In-person counseling

Sun protection

Written advice

Intervention Type BEHAVIORAL

Written advice

Medical skin screening

Intervention Type BEHAVIORAL

Medical skin screening

Interventions

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In-person counseling

In-person counseling

Sun protection

Intervention Type BEHAVIORAL

Written advice

Written advice

Intervention Type BEHAVIORAL

Medical skin screening

Medical skin screening

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut national de la santé et de la recherche médicale, CIC 1415, TOURS

UNKNOWN

Sponsor Role collaborator

Institut national de la santé et de la recherche médicale, U930,TOURS

UNKNOWN

Sponsor Role collaborator

Institut d'Enseignement à Distance,University Paris - 8

UNKNOWN

Sponsor Role collaborator

University Hospital, Tours

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laurent MACHET, MD-PHD

Role: STUDY_DIRECTOR

University Hospital, Tours

Locations

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CHU - ANGERS , Service de Dermatologie

Angers, , France

Site Status

CHRU BREST Hôpital du Morvan, Institut de Cancérologie et d'Hématologie

Brest, , France

Site Status

GH La Rochelle Ré Aunis-Service de Dermatologie

La Rochelle, , France

Site Status

Ch Le Mans

Le Mans, , France

Site Status

CHU NANTES, Service de Dermatologie

Nantes, , France

Site Status

CHU-Poitiers _LA MILETRIE POLE MEDIPOOL-DERMATO-ALLERGOLOGIE

Poitiers, , France

Site Status

CHU -RENNES -Service de Dermatologie-CHU Pontchaillou

Rennes, , France

Site Status

Centre Eugène Marquis -Service d'Oncologie médicale

Rennes, , France

Site Status

University Hospital of Tours, Service de Dermatologie

Tours, , France

Site Status

Countries

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France

References

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Marce D, Le Vilain-Abraham F, Bridou M, Quereux G, Dupuy A, Lesimple T, Le Corre Y, Wierzbicka-Hainaut E, Legoupil D, Celerier P, Maillard H, Machet L, Caille A. Impact of Distribution of a Tip Sheet to Increase Early Detection and Prevention Behavior among First-Degree Relatives of Melanoma Patients: A Randomized Cluster Trial. Cancers (Basel). 2022 Aug 10;14(16):3864. doi: 10.3390/cancers14163864.

Reference Type RESULT
PMID: 36010858 (View on PubMed)

Other Identifiers

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2016-A00186-45

Identifier Type: REGISTRY

Identifier Source: secondary_id

INCA14/LM-FADEMELA

Identifier Type: -

Identifier Source: org_study_id