Comparison of Two Strategies for Counseling Skin Examination and Sun Protection in First-degree Relatives of Patients With Melanoma
FADEMELA
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
2 other identifiers
interventional
420
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2017
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2016
CompletedFirst Posted
Study publicly available on registry
September 28, 2016
CompletedStudy Start
First participant enrolled
December 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 26, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 10, 2019
CompletedDecember 30, 2025
December 1, 2025
1.4 years
July 28, 2016
December 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Self-skin examination reported by the relatives
1 year
Sun protection behaviors reported by the relatives
1 year
Barriers to skin examination identified from psychological questionnaires in patients and their relatives
1 year
Study Arms (2)
Control
OTHEREducation 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
Intervention group
EXPERIMENTALEducation 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
- st degree relatives informed by patients and agreeing to fill out the psychological questionnaires and to the use of their personal data by the investigators.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
CHU - ANGERS , Service de Dermatologie
Angers, 49033, France
CHRU BREST Hôpital du Morvan, Institut de Cancérologie et d'Hématologie
Brest, 29000, France
GH La Rochelle Ré Aunis-Service de Dermatologie
La Rochelle, 17000, France
Ch Le Mans
Le Mans, 72000, France
CHU NANTES, Service de Dermatologie
Nantes, 44000, France
CHU-Poitiers _LA MILETRIE POLE MEDIPOOL-DERMATO-ALLERGOLOGIE
Poitiers, 86000, France
CHU -RENNES -Service de Dermatologie-CHU Pontchaillou
Rennes, 35000, France
Centre Eugène Marquis -Service d'Oncologie médicale
Rennes, 35042, France
University Hospital of Tours, Service de Dermatologie
Tours, 37044, France
Related Publications (1)
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.
PMID: 36010858RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Laurent MACHET, MD-PHD
University Hospital, Tours
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2016
First Posted
September 28, 2016
Study Start
December 13, 2017
Primary Completion
April 26, 2019
Study Completion
July 10, 2019
Last Updated
December 30, 2025
Record last verified: 2025-12