Clinical trial NCT02917473: Comparison of Two Strategies for Counseling Skin Examination and Sun Protection in First-degree Relatives of Patients With Melanoma
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Melanoma
Screening
Keywords: Medical skin examination
Skin Self Examination
Sun protection
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
Collaborators: name: Institut national de la santé et de la recherche médicale, CIC 1415, TOURS
name: Institut national de la santé et de la recherche médicale, U930,TOURS
name: Institut d'Enseignement à Distance,University Paris - 8
First posted: 2016-09-28
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Consulting general practitioner or dermatologist
timeFrame: 1 year
Secondary outcomes:
measure: Self-skin examination reported by the relatives
timeFrame: 1 year
measure: Sun protection behaviors reported by the relatives
timeFrame: 1 year
measure: Barriers to skin examination identified from psychological questionnaires in patients and their relatives
timeFrame: 1 year
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU - ANGERS , Service de Dermatologie
city: Brest
country: France
facility: CHRU BREST Hôpital du Morvan, Institut de Cancérologie et d'Hématologie
city: La Rochelle
country: France
facility: GH La Rochelle Ré Aunis-Service de Dermatologie
city: Le Mans
country: France
facility: Ch Le Mans
city: Nantes
country: France
facility: CHU NANTES, Service de Dermatologie
city: Poitiers
country: France
facility: CHU-Poitiers _LA MILETRIE POLE MEDIPOOL-DERMATO-ALLERGOLOGIE
city: Rennes
country: France
facility: CHU -RENNES -Service de Dermatologie-CHU Pontchaillou
city: Rennes
country: France
facility: Centre Eugène Marquis -Service d'Oncologie médicale
city: Tours
country: France
facility: University Hospital of Tours, Service de Dermatologie
Study officials:
affiliation: University Hospital, Tours
name: Laurent MACHET, MD-PHD
role: STUDY_DIRECTOR
References: