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

Melanoma Clinical Trial

— FADEMELA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02917473
• Other study ID #: INCA14/LM-FADEMELA
• Secondary ID: 2016-A00186-45
• Status: Completed
• Phase: N/A
• Start date: December 13, 2017
• Est. completion date: July 10, 2019

Study information

• Verified date: July 2019
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: July 10, 2019
• Est. primary completion date: April 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma
• Screening

Intervention

Behavioral:
• In-person counseling
In-person counseling Sun protection
• Written advice
Written advice
• Medical skin screening
Medical skin screening

Locations

Country	Name	City	State
France	CHU - ANGERS , Service de Dermatologie	Angers
France	CHRU BREST Hôpital du Morvan, Institut de Cancérologie et d'Hématologie	Brest
France	GH La Rochelle Ré Aunis-Service de Dermatologie	La Rochelle
France	Ch Le Mans	Le Mans
France	CHU NANTES, Service de Dermatologie	Nantes
France	CHU-Poitiers _LA MILETRIE POLE MEDIPOOL-DERMATO-ALLERGOLOGIE	Poitiers
France	Centre Eugène Marquis -Service d'Oncologie médicale	Rennes
France	CHU -RENNES -Service de Dermatologie-CHU Pontchaillou	Rennes
France	University Hospital of Tours, Service de Dermatologie	Tours

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Tours	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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Consulting general practitioner or dermatologist	The number of relatives who will have consulted a dermatologist or a general practitioner to perform whole body skin examination	1 year
Secondary	Self-skin examination reported by the relatives	The number of relatives who declare to have performed Self-skin examination.	1 year
Secondary	Sun protection behaviors reported by the relatives	Sun protection behaviours reported by the relatives and assessed by a questionnaire	1 year
Secondary	Barriers to skin examination identified from psychological questionnaires in patients and their relatives	Psychological barriers of patients and their relatives to skin examination evaluated with several questionnaires and scales.	1 year