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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-A00186-45 | Registry Identifier | RCB |
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| Name | Class |
|---|---|
| Institut national de la santé et de la recherche médicale, CIC 1415, TOURS | UNKNOWN |
| Institut national de la santé et de la recherche médicale, U930,TOURS | UNKNOWN |
| Institut d'Enseignement à Distance,University Paris - 8 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Other | 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 |
|
| Intervention group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| In-person counseling | Behavioral | In-person counseling Sun protection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Self-skin examination reported by the relatives | The number of relatives who declare to have performed Self-skin examination. | 1 year |
| Sun protection behaviors reported by the relatives | Sun protection behaviours reported by the relatives and assessed by a questionnaire |
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Inclusion Criteria:
For Patients:
For 1st degree relatives:
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| Name | Affiliation | Role |
|---|---|---|
| Laurent MACHET, MD-PHD | University Hospital, Tours | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU - ANGERS , Service de Dermatologie | Angers | 49033 | France | |||
| CHRU BREST Hôpital du Morvan, Institut de Cancérologie et d'Hématologie |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36010858 | Result | 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. |
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| Written advice | Behavioral | Written advice |
|
| Medical skin screening | Behavioral | Medical skin screening |
|
| 1 year |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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