MelanomaFADEMELANCT02917473
Comparison of Two Strategies for Counseling Skin Examination and Sun Protection in First-degree Relatives of Patients With Melanoma
A study testing In-person counseling, Written advice and Medical skin screening in people with Melanoma and Screening, run by University Hospital, Tours at 9 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- In-person counseling, Written advice and Medical skin screening
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 9 sitesFrance
- Study dates
- 13 Dec 2017to 10 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
CHU - ANGERS , Service de Dermatologie
Angers, 49033
CHRU BREST Hôpital du Morvan, Institut de Cancérologie et d'Hématologie
Brest, 29000
GH La Rochelle Ré Aunis-Service de Dermatologie
La Rochelle, 17000
Ch Le Mans
Le Mans, 72000
CHU NANTES, Service de Dermatologie
Nantes, 44000
CHU-Poitiers _LA MILETRIE POLE MEDIPOOL-DERMATO-ALLERGOLOGIE
Poitiers, 86000
CHU -RENNES -Service de Dermatologie-CHU Pontchaillou
Rennes, 35000
Centre Eugène Marquis -Service d'Oncologie médicale
Rennes, 35042
University Hospital of Tours, Service de Dermatologie
Tours, 37044
About this study
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
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.
Read the 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.
- Being tested
- In-person counseling, Written advice, Medical skin screening
- Keywords
- Medical skin examination, Skin Self Examination, Sun protection
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-person counselingBehavioural
In-person counseling
Sun protection
Written adviceBehavioural
Written advice
Medical skin screeningBehavioural
Medical skin screening
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: In-person counseling; Behavioral: Medical skin screening |
| 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. Receives: Behavioral: In-person counseling; Behavioral: Written advice; Behavioral: Medical skin screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (3)
Self-skin examination reported by the relatives
The number of relatives who declare to have performed Self-skin examination.
Measured: 1 year
Sun protection behaviors reported by the relatives
Sun protection behaviours reported by the relatives and assessed by a questionnaire
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study start13 Dec 2017
- Primary completion26 Apr 2019
- Study completion10 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Laurent MACHET, MD-PHD, Study director, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02917473
- Sponsor's protocol ID
- INCA14/LM-FADEMELA
- Other IDs
- 2016-A00186-45
- Acronym
- FADEMELA
- Status last verified
- Dec 2025
- First submitted
- 28 Jul 2016
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36010858
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02917473
- Acronym / sponsor ID
- FADEMELA / INCA14/LM-FADEMELA
- Keywords
- Medical skin examination, Skin Self Examination, Sun protection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- 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
- Study start
- 13 Dec 2017 (actual)
- Primary completion
- 26 Apr 2019 (actual)
- Study completion
- 10 Jul 2019 (actual)
- First posted
- 28 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Behavioral: In-person counseling, Behavioral: Medical skin screeningEducation 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 | Behavioral: In-person counseling, Behavioral: Written advice, Behavioral: Medical skin screeningEducation 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-person counselingIn-person counseling Sun protection | Behavioural | Control, Intervention group |
| Written adviceWritten advice | Behavioural | Intervention group |
| Medical skin screeningMedical skin screening | Behavioural | Control, Intervention group |
Primary outcome
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
3 secondary outcomes
Self-skin examination reported by the relatives
Time frame: 1 year
Sun protection behaviors reported by the relatives
Time frame: 1 year
Barriers to skin examination identified from psychological questionnaires in patients and their relatives
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Results publication: PubMed 36010858Marce 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent MACHET, MD-PHD study director
University Hospital, Tours
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-person counseling, Written advice and Medical skin screening in people with Melanoma and Screening, run by University Hospital, Tours at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consulting general practitioner or dermatologist (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02917473, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.