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

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ClinicalTrials.gov Identifier: NCT02917473
Recruitment Status : Completed
First Posted : September 28, 2016
Last Update Posted : July 17, 2019
Sponsor:
Collaborators:
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
Institut d'Enseignement à Distance,University Paris - 8
Information provided by (Responsible Party):
University Hospital, Tours

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.

Condition or disease Intervention/treatment Phase
Melanoma Screening Behavioral: In-person counseling Behavioral: Written advice Behavioral: Medical skin screening Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Screening
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
Actual Study Start Date : December 13, 2017
Actual Primary Completion Date : April 26, 2019
Actual Study Completion Date : July 10, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

Behavioral: In-person counseling

In-person counseling

Sun protection


Behavioral: Medical skin screening
Medical skin screening

Experimental: 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.

Behavioral: In-person counseling

In-person counseling

Sun protection


Behavioral: Written advice
Written advice

Behavioral: Medical skin screening
Medical skin screening




Primary Outcome Measures :
  1. Consulting general practitioner or dermatologist [ Time Frame: 1 year ]
    The number of relatives who will have consulted a dermatologist or a general practitioner to perform whole body skin examination


Secondary Outcome Measures :
  1. Self-skin examination reported by the relatives [ Time Frame: 1 year ]
    The number of relatives who declare to have performed Self-skin examination.

  2. Sun protection behaviors reported by the relatives [ Time Frame: 1 year ]
    Sun protection behaviours reported by the relatives and assessed by a questionnaire

  3. Barriers to skin examination identified from psychological questionnaires in patients and their relatives [ Time Frame: 1 year ]
    Psychological barriers of patients and their relatives to skin examination evaluated with several questionnaires and scales.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02917473


Locations
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France
CHU - ANGERS , Service de Dermatologie
Angers, France, 49033
CHRU BREST Hôpital du Morvan, Institut de Cancérologie et d'Hématologie
Brest, France, 29000
GH La Rochelle Ré Aunis-Service de Dermatologie
La Rochelle, France, 17000
Ch Le Mans
Le Mans, France, 72000
CHU NANTES, Service de Dermatologie
Nantes, France, 44000
CHU-Poitiers _LA MILETRIE POLE MEDIPOOL-DERMATO-ALLERGOLOGIE
Poitiers, France, 86000
CHU -RENNES -Service de Dermatologie-CHU Pontchaillou
Rennes, France, 35000
Centre Eugène Marquis -Service d'Oncologie médicale
Rennes, France, 35042
University Hospital of Tours, Service de Dermatologie
Tours, France, 37044
Sponsors and Collaborators
University Hospital, Tours
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
Institut d'Enseignement à Distance,University Paris - 8
Investigators
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Study Director: Laurent MACHET, MD-PHD University Hospital, Tours

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Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT02917473     History of Changes
Other Study ID Numbers: INCA14/LM-FADEMELA
2016-A00186-45 ( Registry Identifier: RCB )
First Posted: September 28, 2016    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Tours:
Medical skin examination
Skin Self Examination
Sun protection

Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas