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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

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.

In-person counseling

Written advice

Medical skin screening

Laurent MACHET, MD-PHD

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.

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

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

The number of relatives who will have consulted a dermatologist or a general practitioner to perform whole body skin examination

The number of relatives who declare to have performed Self-skin examination.

Sun protection behaviours reported by the relatives and assessed by a questionnaire

Psychological barriers of patients and their relatives to skin examination evaluated with several questionnaires and scales.

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

University Hospital, Tours

Mole Mapping Diagram

Martin A Weinstock, MD, Ph.D

This study aims to improve Skin Self-Examination accuracy by a simple cost effective intervention requiring participants to complete a mole-mapping diagram.

The Use of Mole Mapping Diagrams to Increase Skin Self Examination Accuracy

Brown University

In the in-person training the Research Assistant demonstrates the use of a mm ruler, a lighted magnifying lens, a set of body maps and a scorecard, 4 pens, ABCDE rule on the skin exam card and discusses the ABCDE rule by pointing to the color examples on the skin exam card. 165 pairs (330 subjects) are randomized to this arm.

The workbook, which includes all of the information delivered in the in-person intervention, is 39 pages in length, and has 76 color figures. Each element of the in-person training represents a chapter in the workbook. The introduction explores the partners' understanding of melanoma and their personal risk of developing another melanoma, and attitudes about the benefit of early detection assisted by a partner. The early detection segment uses a skin diagram to illustrate the difference between thin and thick melanoma and presents the treatment based on the depth of the melanoma. 165 pairs (330 subjects) are randomized to this arm.

Education and counseling as usually delivered in clinical practice. 100 pairs (200 subjects) are randomized to this arm.

Education will be given by an interactive tablet app. Each pair will view video recordings of certain parts of the in-person presentation as well as select slides from the in-person PowerPoint presentation. Parts of the workbook will be incorporated as well. 70 pairs (140 subjects) are randomized into this arm.

The design is a 3 \[in-person training of patients and partners (PARTNER) vs. workbook training of patients and partners (WORKBOOK) vs. an assessment only group that receives education and treatment as usual care\] X 7 \[baseline, 4, 8, 12, 16, 20, and 24 month follow-up\] study. Standard education of melanoma patients, which are to be performed with the study partner, includes a recommendation to check moles and mark ones to remember on a body map. All participants receive the same measures and will be recruited using the same procedures, thus, yielding equivalence across conditions. Pairs will observe how to use their skin check tools and be asked to demonstrate their competence in using them.

Participants will read a workbook and perform skills training exercises.

Workbook

Participants will receive their education from an interactive app designed for a tablet computer.

Tablet Computer-Based Education

June K Robinson, MD

The almost 724,000 Americans survivors of melanoma are estimated to have 4 first degree relatives per case; thus, 2.8 million Americans are at increased risk of developing melanoma in comparison to the general public. Skin self-examination (SSE) with the assistance of a partner by these individuals could improve survival. If effective, the workbook tested in this proposal could be distributed to people at risk of developing melanoma by large scale means in physicians office.

Population based registries document that survival from melanoma, a growing public health problem with approximately 70,000 new melanoma cases and an estimated 8,600 deaths in 2010, is dependent on the thickness of the melanoma. By facilitating seeking medical care, skin self-examinations (SSEs) by individuals with a prior history of melanoma, who are at risk to develop subsequent melanomas, may lead to the early detection and treatment of melanoma when it is usually more effective. Thus, further research that enhances early detection is warranted and our application directly tests novel methods of training high-risk melanoma patients and their partners on how to conduct SSEs to promote early detection. Our proposed research builds upon the strengths of the R21 that: a) established that in-person training to conduct SSE with a partner significantly enhanced SSE performance 4 months after the intervention, and b) developed and pilot tested a manualized take-home workbook training approach (WORKBOOK). Our pilot work on the WORKBOOK with partners suggests that patient-partner dyads (n = 21) perceived it to be readable, useful, and in the short term 4 month follow-up, empirically equivalent in promoting SSE knowledge, skills, and behaviors compared with patient-partner dyads in the in-person partner training condition (n = 19). Our proposed research builds on our NCI funded studies by conducting a formal examination with 430 pairs (860 subjects) randomized to either the in-person or workbook training vs. an assessment only control group that receives standard of care over a 2 year longitudinal study with 4 month interval evaluations. An additional group of 70 pairs (140 subjects) has been added to test a tablet computer-based program.

Our proposed research directly tests novel methods of training Stage I and IIB melanoma patients, who have a 5 year survival of 80-90%, and their partners, on how to conduct SSEs. We will compare the efficacy of the in-person training vs. workbook for patients and partners vs. controls on SSE knowledge/skill acquisition and retention, and SSE performance and accuracy on a short (4 and 8 months post baseline) and long term basis (12, 16, 20, and 24 months post baseline) and examine whether partner-patient relationship-qualities moderate the relationship between the training approaches and SSEs knowledge/skill acquisition and retention, and SSE performance and accuracy. The tablet computer-based program will also be tested for efficacy and compared with the previous groups.

Establishing health promotion partnerships is important to those at risk to develop melanoma because SSE is difficult to successfully perform as an individual. It is expected that the workbook will promote SSE at least as well as and perhaps better than in-person training and become an easily disseminated SSE training approach that is not dependent on the time and teaching skills of the non-MD clinical office staff.

A Comparison of Interventions to Teach Melanoma Patients Skin Self-examination

publication of results with listing in My NCBI

To compare the self-efficacy of the in-person training vs. workbook for patients and partners by self-report on a survey at 4-month intervals over 24 months.

Accurate identification of concerning lesions (melanoma) by participants performing SSE in comparison with the dermatologist's assessment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparison of Two Strategies for Counseling Skin Examination and Sun Protection in First-degree Relatives of Patients With Melanoma	NCT02917473	Melanoma Screening	In-person couns... Written advice Medical skin sc...	18 Years -	University Hospital, Tours
The Use of Mole Mapping Diagrams to Increase Skin Self Examination Accuracy	NCT00237965	Melanoma	Mole Mapping Di...	18 Years -	Brown University
A Comparison of Interventions to Teach Melanoma Patients Skin Self-examination	NCT01432860	Melanoma	In-person couns... Workbook Tablet Computer...	18 Years - 80 Years	Northwestern University

Spots Global Cancer Trial Database for skin self examination