Mpne 2015 advocacy day

ADVOCACY DAY SUNDAY 25TH APRIL

Conference materials

MPNE 2015- ADVOCACY DAY SUNDAY- 26TH APRIL Session 5- part 1 5.1 Summary of the Friday workshops Gilly Spurrier, Melanome France, France/ MPNE 5.2 Focus on Romania- one year later Ana- Maria Forsea, Romanian Skin Cancer Foundation, Romania/ MPNE 5.3 Networks driving research- The Melanoma susceptibility project Antonella Romanini, ACM, Italy/ MPNE 5.4 The EUPATI- experience Violeta Astratinei, Melanom Romania, Netherlands/ Romania/ MPNE

MPNE 2015- ADVOCACY DAY SUNDAY- 26TH APRIL Session 5- part 1 5.5 Overcoming cancer drugs shortages - the role of volunteer networks and the media Vlad Voiculescu, The Missing Cancer Drugs Initiative, Austria 5.6 How to make the MPNE network work- our communication strategy.

Lori Murdoch, Melanoma Network UK, UK 5.7 Knowledge is power- our education strategy.

Gilly Spurrier, Melanome France, France

MPNE 2015- The risk of NOT taking risks in Melanoma

5.1 Summary of the Friday workshops.

Gilly Spurrier, MelanomeFrance, France Gilly is the founder and driving force behind MĂŠlanome France and spouse to a Melanoma Stage 4 patient.

Gilly is passionate about Patient Empowerment - French Melanoma Patients are under-represented in Europe and have difficulty in accessing relevant information if they don’t speak English.

She strongly believes that Patients are the main stakeholders in their own health and in the fight for equality of care and that they need help to get informed.

She therefore set up MelanomeFrance in 2014 and currently runs the forum, website and admin of the organisation and will do pretty much anything it takes to get patients access to treatments and clinical trials and to help them feel equal partners in their therapy!

www.melanomefrance.com

MPNE 2015 WORKSHOPS SUMMARY AND ACTIONS

OVERVIEW The workshop subjects were iden9fied by par9cipants of the 2014 conference as areas where there was felt to be a need.

At MPNE2015 there were 6 Workshops or special sessions aJended by 59 par9cipants.

We would like to thank all the Par9cipants for their valuable input and also the Facilitators for their 9me, exper9se and dedica9on.

MPNE 2015 WORKSHOPS WORKSHOP I DERMOSCOPY

8 participants plus the four Experts Shared information on skin examination models and patterns What is dermoscopy What it is for What are the devices used How techniques used in different types of monitoring

MPNE 2015 WORKSHOPS DERMOSCOPY ACTIONS

Summary of existing guidelines 930 guidelines narrowed down to 34 so Still complicated – there is currently no consensus on who , how often, by whom and using what technology for skin checks This is why we need a best practice guideline In the second session we attempt to do this with patient input so that it is realistic and patient friendly Thanks to Ana-Maria, Zrinjka, Monika and Selma And to Jane for the Note-taking

MPNE 2015 WORKSHOPS STAGE 4 THERAPIES

Thanks to Pascal Wolter 23 Par9cipants Overview of current Therapies and strategies for stage 4 pa9ents

MPNE 2015 WORKSHOPS • Some drugs work for some pa9ents – but we need to decide what works for which pa9ent • Approval doesn’t guarantee funding especially across Europe • Interes9ng discussion about some case histories

MPNE 2015 WORKSHOPS PSYCHOSOCIAL SUPPORT IN MELANOMA 12 Participants Summary of what is currently available to patients And an assessment of the need for psychosocial support for melanoma patients Great discussion on what patients had in terms of helping them deal with their diagnosis and how this can be improved Thanks to Stefania

MPNE 2015 WORKSHOPS Stefania Bassino Slides

Workshop 3 : Psycho-­‐social Support in Melanoma

Melanoma Patient Network Europe – Workshop Conference 2015 III Â

Psychosocial support in Melanoma Stefania Bassino, Italy

Definitions: stress and distress - Stress was defined as a ‘physical and emotional state always present in the person as a result of living; it is intensified in a non-specific response to an internal or external change or threat’ and it is not always negative.

- Distress: the noun distress is often used by health care professionists in the context of physical, emotional and spiritual conditions.

It is considered a kind of stress that comes from having your well-being threatened, or from being attacked, physically or emotionally.

- Distress causes the heart to race, breathing to become shallow, blood vessels to constrict and even insomnia.

Selye, 1976; Ridner et al., 2004

Relationship between stress/ eustress/distress

Eustress  Positive stress, called eustress comes from the anticipation, or the experience of pleasurable events such as a roller coaster ride, falling in love or waiting for the starting gun for a marathon.

 Eustress may cause some of the same physical symptoms, but is excitement.

Your body processes eustress as positive, and eustress can make you feel good as your body releases endorphins.

Distress, some aspects: Distress is an unpleasant experience of an emotional, psychological, social, or spiritual nature that interferes with the ability to cope with cancer treatment. It extends along a continuum, from common normal feelings of vulnerability, sadness, and fears, to problems that are disabling, such as depression, anxiety, panic, and feeling isolated or in a spiritual crisis.

Distress: • Causes anxiety • Can be short- or long-term • Is perceived as outside of our coping abilities • Feels unpleasant • Decreases performance • Can lead to mental and physical problems

NCCN, 1999

h c y Ps

l a i c o s o

s s e r t s i d

Mutual influence among components of psychosocial distress.

Importance of subjective evaluation of situation.

Specified social/environmental issues

Perception, recall, imagination, anticipation of personal disvalued attributes, behaviours and outcomes

Psychological distress

Personal attributes and behaviors, consequences for person of other behavior

Specified social/environmental issues

Personal needs, value system

Specified social/environmental issues Adaptation from Kaplan H., 1983

Stress and psychological distress

Persistent stress non resolved may lead to psychological distress

Psychosocial support in Melanoma What about psychosocial and psychological distress?

The words “psychological distress� refer to: excessive worry, rumination, irritability, difficult in concentration, insomnia, anhedonia, social avoidance, feelings of loneliness and helplessness and increased somatic complaints such as headache, nausea and heart palpitations.

Kasparian, 2013

Psychological distress in melanoma?

Psychological distress lead to poor health behaviour and quality of life and a worse quality of life conduct to a major psychological distress as in a vicious circle.

Psycho-social and psychological distress (including anxiety and depression) has been associated with patient delay in seeking medical advice, decreased adherence to treatment, lower quality of life, greater medical costs and reduced engagement in post-treatment screening and prevetive behaviors.

Boyle, 2009; Butow et al., 1999; DiMatteo et al., 2000; Kasparian, 2013; Tesio et al. not published

Literature about distress in melanoma - A recent review of the literature highlighted that approximately one-third of melanoma patients experiences clinically relevant levels of psychological distress that may have notable implications for the patient and his/her families.

- About the 44% of patients had relevant distress.

- Anxiety and depression were the most common psychological disorders in people diagnosed with melanoma. The clinical range of anxiety and depression was around 23% and 11% respectively.

- Subjective beliefs about melanoma, its treatment, prognosis and fear about recurrence may play a great role in determining stress responses as well as clinical characteristics of the disease, stage of illness and time since diagnosis.

Kasparian et al, 2009; Tesio et al., not published; Brandberg et al., 1992; Kelly et al. 1995; Kasaprian et al., 2013; Klitter et al., 2001

- Psychological needs of people with melanoma frequently go undetected and unmet.

- Illness perceptions are correlated with patients quality of life, anxiety and depression.

- Subjective factors may be more important than objective medical factors in predicting patient adjstment to illness.

- Importance of the influential role of psychological factors in individual susceptibility and adaptation to cancer.

- High percentage of anxiety (25%) and distress symptoms (44%) in patients with early stages melanoma, while depressive symptoms seem to be less frequent (8%).

Kasparian, 2013; Zivkovic et al., 2008; Hamama-Raz et al., 2007; Tesio et al. not published

-  The presence of psychological distress has a negative impact not only on cancer patients’ personal and social quality of life, but also on the course of the disease, with slower recovery and increased morbidity.

-  The psychological status of the patient is one of the key factors that influence the time of turning promptly to the specialist and the adherence to the medical prescription.

- The presence of distress has been associated not only with decreased adherence to treatments, delay in seeking medical advice for melanoma, reduced engagement in post-treatment skin cancer, screening and preventive behaviors, but it has also been associated with lower quality of life and increased rates of melanoma, recurrences and mortality.

Trask, et al. 2001; Kasparian et al., 2012; Kendall et al., 2011; Chida et al., 2008; Carlson et al., 2003; DiMatteo et al., 2000; Hay et al., 2005; Kasparian et al., 2009.

Distress and coping One of the variables that showed to be more related to the psychological status is the coping ability. The term “coping” includes “attitudes and behaviors that have an adaptive intent when dealing with a threatening situation”.

Maladaptive responses, and in particular self-blame, behavioral disengagement, substance use and denial at baseline were more strongly related to increased levels of psychological distress at follow-up.

Nielsen et al., 2014

- Patients that showed higher levels of emotional distress and depressive/anxiety symptoms are those patients that used more negative coping strategies, such as self-distraction, denial, behavioural-disengagement, and self-blame .

- The most useful coping strategies to adopt for an individual affected by melanoma patients are: facing the reality of one’s illness, maintaining hope and optimism, expressing one’s emotions, seeking support from others, adopting a participatory stance, and maintaining self-esteem.

Kneier et al., 2003; Tesio et al., not published

Risk factors - - - - -

Female sex.

Younger age.

The absence of a partner.

Lower/higher level of education.

Pshysical deterioration and visibility of body side were associated with altered body image and fears of recurrence.

- Lack of social support and avoidance coping style.

Kasparian et al., 2011; Tesio et al., not published; Atkinson et al., 2012; Roberts et al., 2012

Consequences of psychological distress - - - - - - -

Decreased adherence to treatment regimes Lower quality of life.

Reduced enrollment in follow-up programs.

Delay in seeking medical advice.

Increased medical costs.

Anxiety and depression.

Loss of appetite, insomnia.

Brown et al., 2000; Kennard et al., 2014; Letho et al., 2007; Sollner et al., 2001

What about real patients experiences

-­‐ What do you think about psychological distress?

-­‐ Is something you experienced?

-­‐ How do you face it?

-­‐ What do you think we could do to prevent or treat this side of cancer?

What about psysicians opinion on psychological distress in melanoma?

-­‐ What do you think people with melanoma need? (e.g. informations, support…)

-­‐ What do you think we could do to prevent or treat psychological distress?

How to identify and manage psychological distress – literature  The Na9onal Comprehensive Cancer Network has the broad goal of establishing standards of care so that all pa9ents experiencing psychosocial distress will be accurately and rou9nely iden9fied, recognized, and treated.

These guidelines include recommenda9ons for the following:  Screening.  Triage.  Ini9al evalua9on.

Also included are referral and treatment guidelines for each par9cipa9ng profession:  Mental health (psychology and psychiatry).  Social work.  Pallia9ve care.  Pastoral care.

The 9mes most likely to require screening include the following periods during the illness when distress is most likely to occur:  Shortly aeer diagnosis.  At start of treatment (surgery, radia9on, and chemotherapy).  At conclusion of a long course of treatment.  Periodically during post-­‐treatment and remission.  At 9me of recurrence.  With transi9on to pallia9ve care.

Example from literature – screening for patients

Treatment and prevention

A well -­‐timed psych ability ologic to cop e with al interven of acti tio a ve contri and positiv threatening n that focus bu si ed on e the pa melan te to redu strategies in tuation, str tients’ ce the e oma p s n t g e t a h d

e

atient

o n psycho f the n ing th s also e use logica egativ many l e

d o ist ne years a fter th ress experi , could e e remi ssion. nced by

Tesio et al., not published

References

• 1: Kasparian NA. Psychological care for people with melanoma: what, when, why and how? Semin Oncol Nurs.

2013 Aug;29(3):214-22.

• 2: Ridner SH. Psychological distress: concept analysis. J Adv Nurs. 2004 Mar;45(5):536-45.

• 3: Kasparian NA, McLoone JK, Butow PN. Psychological responses and coping strategies among patients with malignant melanoma: a systematic review of the literature. Arch Dermatol. 2009 Dec;145(12):1415-27.

• 4: Cornish D, Holterhues C, van de Poll-Franse LV, Coebergh JW, Nijsten T. A systematic review of health-related quality of life in cutaneous melanoma. Ann Oncol. 2009 Aug;20 Suppl 6:vi51-8.

• 5: Hamama-Raz Y, Solomon Z, Schachter J, Azizi E. Objective and subjective stressors and the psychological adjustment of melanoma survivors. Psychooncology.2007 Apr;16(4):287-94.

• 6: Hamama-Raz Y. Does psychological adjustment of melanoma survivors differs between genders?

Psychooncology. 2012 Mar;21(3):255-63. doi: 10.1002/pon.1889. Epub 2010 Dec 19 • 7. Thomas BC, NandaMohan V, Nair MK, Pandey M. Gender, age and surgery as a treatment modality leads to higher distress in patients with cancer. Support Care Cancer. 2010 Feb;19(2):239–50.

• 8. Loquai C, Scheurich V, Syring N, Schmidtmann I, Rietz S, Werner A, et al. Screening for distress in routine oncological care-a survey in 520 melanoma patients. PLoS One. 2013 Jan;8(7):e66800.

• 9. Beesley VL, Smithers BM, Khosrotehrani K, Khatun M, O'Rourke P, Hughes MC, Malt MK, Zonta MJ, Bayley GJ, Barbour AP, Brown LJ, D'Arcy J, Allan CP, Green AC. Supportive care needs, anxiety, depression and quality of life amongst newly diagnosed patients with localised invasive cutaneous melanoma in Queensland, Australia.

Psychooncology. 2014 Oct 29.

• 10. National Comprehensive Cancer Network (2012) NCCN Distress Management Clinical Practice Guidelines in Oncology.

• 11. Holland JC NCCN practice guidelines for the management of psychosocial distress, Oncology

(1999) 13:

113-147 .

• 12. Brown JE, Butow PN, Culjak G, Coates AS, Dunn SM. Psychosocial predictors of outcome: time to relapse and survival in patients with early stage melanoma. Br J Cancer. 2000 Dec;83(11):1448-53.

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14. Lehto US, Ojanen M, Dyba T, Aromaa A, Kellokumpu-Lehtinen P. Baseline psychosocial predictors of survival in localized melanoma. J Psychosom Res. 2007 Jul;63(1):9-15.

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15. Söllner W, DeVries A, Steixner E, Lukas P, Sprinzl G, Rumpold G, Maislinger S. How successful are oncologists in identifying patient distress, perceived social support, and need for psychosocial counselling? Br J Cancer. 2001 Jan;84(2): 179-85.

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16. Tesio V, Castelli L, Ribero S, Bassino S, Leombruni P, Caliendo V, Grassi M, Lauro D, Macripò G, Torta R. Psychological characteristics of early-stage melanoma patients: a cross-sectional study on 204 patients. European Journal of Cancer Care (not yet published).

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17. Selye H. Further thoughts on "stress without distress". Med Times. 1976 Nov;104(11):124-44.

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18. Nezu AM, Nezu CM, Felgoise SH, McClure KS, Houts PS. Project Genesis: assessing the efficacy of problemsolving therapy for distressed adult cancer patients. J Consult Clin Psychol. 2003 Dec;71(6):1036-48.

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19. Trask PC, Paterson AG, Hayasaka S, Dunn RL, Riba M, Johnson T. Psychosocial Characteristics of Individuals With Non–Stage IV Melanoma. J Clin Oncol. 2001;19(11):2844–50. 8.

MPNE 2015 WORKSHOPS EMA SESSION 30 par9cipants

MPNE 2015 WORKSHOPS DERMOSCOPY IN PRACTICE 9 par9cipants We took the summary guidelines And discussed each element To have the pa9ent perspec9ve on how feasible and helpful the strategy is and what aspects need tweaking.

MPNE 2015 WORKSHOPS

will follow up with their The Dermoscopy Ladies definiKve guidelines w hich have been decided Between the 4 experts and the paKents

MPNE 2015 WORKSHOPS STAGE 3 THERAPIES 13 Par9cipants

Thanks to Dirk And Jackie for notetaking

MPNE 2015 WORKSHOPS • All the stages were defined and explained – micro and macro nodal metastases • Survival 9mes and relapse poten9al • Radical lymph node dissec9on discussion is NOT cura9ve • Whether it benefits or not do you have no op9on but to do it ? 50% have no further occurrence ..

• radiotherapy for maJed nodal disease ?

MPNE 2015- The risk of NOT taking risks in Melanoma

5.2 Focus on Romania- one year later Ana- Maria Forsea, Romanian Skin Cancer Foundation, Romania/ MPNE ‘I acquired my dermatology specialty training in Bucharest, Romania and in Berlin, Germany, and my doctoral degree at the Free University of Berlin, Germany, with a fundamental research work in the field of experimental therapeutic molecules for melanoma. I completed my education in dermato-oncology with the Visiting Fellowship of the American Academy of Dermatology at Memorial Sloan-Kettering Cancer Center, New York, USA and pursued my post-doctoral research as Visiting Scientist at Harvard School of Public Health, Boston, USA, researching on strategies and education programs for skin cancer early detection.

Melanoma has always been my main scientific interest, but my latest work, both in research and in patient advocacy is spurred by the challenges I face in the daily care for skin cancer patients in Romania. Late detection of advanced tumours, lack of awareness both in patients and physicians, lack of epidemiologic data and control, shortages in diagnostic and care facilities and lately lack of access to new treatments and trials are the dramatic reality that Romania shares with much of the Eastern half of Europe, for skin cancer and cancer in general. Consequently my research is directed at strategies and techniques for skin cancer early detection, cancer registration, and medical and public education for cancer prevention, with a strong focus on intra-European disparities in skin cancer burden and access to care.’

ESO:M:ICAB CONFERENCE 28-30 March 2014 - Brussels, Belgium

PATIENT PARTICIPATION IN MELANOMA CLINICAL RESEARCH Focus on…

Large differences exists in terms of melanoma prognosis but also of melanoma advocacy activity between European countries The network of existing European melanoma advocates has the shared knowledge and experience to help boost the action in the countries where it is most needed.

Join us for the Focus session, in order to bring together our knowledge, network and ideas to find solution for our problems- one by one.

ROMANIA

Priority areas ¨

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Early detection ¤ Patients awareness ¤ Physicians education Access to treatment/clinical trials ¤ Information points for patients ¤ Clinical trials database ¤ Lobby for n improved regulation of cancer health care n Interdisciplinary care Registration ¤ Lobby for cancer registration

Focus proposals (2014) EARLY DETECTION 1. Patients awareness Reaching rural population: ¨ Video/TV ¨ schools-teachers ¨ men's club (pub) ¨ touring dermatologists ¨ football/bier mat ¨ UV-sensitive objects (kids?)

Reaching Urban population ¨ Euro-melanoma Day ¨ Women magazines 2. Physicians education ¨ - Existing materials C. REGISTRATION Lobby for cancer registration

B. ACCESS TO TREATMENT/ TRIALS 1. Information points for patient ¨ Written materials for physicians offices ¨ Legal requirement to hand out written Still no reimbursed new drugs information to patients ¨ Approved by national medical board + backed by official authority 2. Clinical Trials Map reasons for the lack of clinical trials 3. Lobby Improved regulation of cancer care - certification for interdisciplinary center Reward interdisciplinary care - "Doctor of the heart" - "Best interdisciplinary team /institution" - Awareness for Politicians

Patient advocacy in melanoma volunteering work Romania 2014 q

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Set up of a blog Melanom Romania displaying latest info on clinical trials and innovative treatments.

Facebook page and a Twitter account Melanom Romania Starting the NGO Melanoma Patients Association Founded a Melanoma Patient Group – a forum where patients can meet online share , support each other and learn about treatments and tests in melanoma.

Implementing the educational program for patients advocates EUPATI.

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Eurodermoscopy logo

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33 participating European countries > 8500 Responses 23% of all European registered dermatologists 36% Overall response rate 74.9% Dermoscopy use

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Research/ education projects melanoma Application Horizon 2020 ESSCAPE European Strategies for Skin Cancer Screening and Prevention ¨

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Evaluating existing screening and prevention programmes in Europe 13 partners consortium

National TE grant application MULTISCAN Multifactorial Study On The Determinants Of Skin Cancer Late Detection Towards The Elaboration Of Strategic Directions For Intervention ¨

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European School of Dermato-Oncology Scholarship of Romanian Dermatologic Society for a dermatology resident

A spotless future – Melanoma Awareness Campaign (2013 & 2014) May – July 2013

June-September 2014

Campaign Goal

• Start awareness on melanoma at national level

• Continue to communicate on melanoma

Objectives

• Educate young people, media and PAGs on prevention ,early detection, monitor and treatment of the disease

• Increase education of general public • Create media debate on prevention and early detection

Target Groups

• Young Adults

• General Public • Journalists • Authorities

• Journalists • Authorities

Activities

• Disease training for journalists and PAGs • Meetings with students communities- Bucharest, Brasov, Cluj • Press conference • One-day campaign in Romanian Parliament • www.info-melanom.ro – launch, including patient testimonial

• Press conference • Mee+ngs with general public during sports events – free tests at Bucharest, Brasov, Cluj • Bloggers involvement • www.facebook.com/unviitorfarapata -­‐ launch • Melanoma info graphic – launch • One-day campaign in Romanian Parliament 5/15/15

MPNE 2015- The risk of NOT taking risks in Melanoma

5.3 Networks driving research- The Melanoma susceptibility project Antonella Romanini, ACM, Italy/ MPNE ‘I am an oncologist taking care of melanoma patients for the last 20 years, President of a patients organization : Associazione contro il Melanoma ONLUS, which I founded several years ago, www.associazionecontromelanoma.it I like travelling, photography, reading, scuba diving, friends and any human being. I am especially thankful to my patients who did me much more than I was able to do for them’

The Melanoma susceptibility project Antonella Romanini, MD on behalf of Associazione Contro il Melanoma O.N.L.U.S. Pisa, Italy

Introduction • We alll know that detecting melanoma early in its developement is still nowadays the most effective way to save lives. That is why the Associazione Contro il Melanoma dedicates a consistent part of its mission to educate children at school and to study the best possible way to detect melanoma at its early stage.

• Guidelines all over the world recommend selecting the population at risk. Different countries recommend more or less the same known risk factors Subjects at high risk: Many melanocytic naevi, dysplastic naevi, family history, large congenital naevi and Fitzpatrick I-II skin types.

C.G. Watts et al. Br. J. of dermatology 2014

Risk factors for CM development Meta-analysis (354 papers) •

Intermittent sun exposure:

SRR=1.61 (1.31; 1.99)

Sunburns: •

Skintype/Phenotype at increased risk: Phototype I vs IV-V: Freckles: Naevi (>100): Red hair vs dark:

•

SRR= 2.03 (1.73; 2.37)

Family history:

SRR=2.09 (1.67, 2.58) SRR=2.10 (1.80, 2.45) SRR=6.89 (4.63; 10.25) SRR=3.64 (2.56, 5.37) SRR=1.74 (1.41, 2.14)

The WHO estimates 65,161 people a year worldwide die from too much sun.

We all know that dark skin subjects do develop melanoma, but they are usually left out from screening programs Gandini et al. Eur J Cancer 2005. Environmental Burden of Disease Series, N.13. 2006.

RM1

Pooled analysis: 17 studies on MC1R (MSKIP) 5 160 cases and 12 119 controls

MC1R variants are very common: 66% of this study population had at least one variant.

Risk attributable to MC1R variants was 28%.

For darker-pigmented subjects with MC1R variants: SOR=3.14 (2.06-4.80) Preventive strategies may be directed not only to fair-skinned subjects but also darker-pigmented Caucasians with MC1R variants.

Pasquali et al. International Journal of Cancer. 2014

MCR6

MC1R is highly polymorphic in the Caucasian population •

MC1R maps to chromosome 16q24.3

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It is expressed on 14 cell types, including melanocytes

•

About 100 variants of MC1R protein have been described, of which 9 have been demonstrated to be loss of function variants.

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MC1R variants have also been found to be associated with both MM and non-melanoma skin cancer (NMSC) risks Variants

Function

Val60Leu Ile40Thr Arg142His Arg151Cys Arg162Pro Arg160Trp Asp294His

weacker stimulators of cAMP production

Val122Met

decreased a-MSH binding affinity red hair and fair skin phenotype (RHC)

Arg151Cys Arg160Trp Asp294His

Three-dimensional predicted structural model of MC1R

Val60Leu, 86insA Asp84Glu Arg142His Ile155Thr 537insC His260Pro

full or partial RHC causing alleles

MC1R melanocortin receptor 1 •

Encodes a G protein coupled receptor with 7 transmembrane domains

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MC1R is the receptor of two melanocortin peptides synthesised in the pituitary gland, alpha melanocyte stimulating hormone (α-MSH) and ACTH

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These have the same affinity for MC1R, and are cleavage products of the large precursor peptide proopiomelanocortin

•

Their binding to this receptor promotes: adenylate cyclase activity and consequent c-AMP production

Leading to: Ø enhanced tyrosinase transcription and transduction Ø production of photoprotective eumelanin Ø melanocytes proliferation.

MCR1

MC1R signaling in melanomagenesis beyond melanogenesis •

In darkly pigmented Caucasians MC1R variants are detected in 15% to 33% among dark-haired individuals and to 42% among darkeyed individuals (Kanetsky PA, Cancer 2010)

•

MC1R variants are more frequently detected in melanomas with somatic Braf mutation, suggesting that MC1R variants may have more specific roles in UV-induced mutagenesis

q q

Landi MT, Science, 2006; Fargnoli MC, J. Invest. Dermathol, 2008; Scherer, D J. Invest.

Dermathol, 2010; Kim RD, Pigmented Cell Mel. Res, 2008.

q

MCR3

Between 8 to 33% of all melanomas could be detected early in their natural history and potentially cured by screening for MC1R [R] variants among persons with protective phenotypes.

Kanetsky PA, Cancer. 2010 May 15; 116(10): 2416–2428.

MeSu Study proposal • Case control prospective study • Statistical considerations Based on multiple logistic regression • It tests the relationships between independent variables (risk factors) and dependent variable (presence of melanoma), since the dependent variable is binary • It produces probabilities of the presence/absence of melanoma given the risk factors, based on odds ratio

MeSu Study proposal: Population and methods • Dark skin Caucasians, age range 18-65, from screening melanoma campaigns tested for MC1R polymorfisms • Dark skin Caucasians harbouring MC1R polymorfism at risk (case) • Dark skin Caucasians MC1R wild type (control) • Prospectively followed for 5 years • Data on other known melanoma risk factors and sun bed use collected • At least 500 dark skin Caucasian subjectsenrolled in all Europe 2–3 ml of saliva will be collected in a sterile plastic tube with Oragene® solution Samples do not need to be frozen, may be stored at room temperature DNA sequencing will be centralyzed in Pisa Each test will cost approximately 25 € Estimated total costs: 15.000 €

MeSu Study proposal: objectives • To prospectively validate MC1R polymorfisms as a risk factor in dark skin Caucasians • To determine RR of developing a melanoma in dark skin Caucasians harbouring MC1R polymorfisms compared to dark skin Caucasians harbouring wt MC1R • To evaluate the inclusion of DNA test for MC1R polymorfism in melanoma screening programs

MPNE 2015- The risk of NOT taking risks in Melanoma

5.4 The EUPATI- experience Violeta Astratinei, Melanom Romania, Netherlands/ Romania/ MPNE Violeta is a biologist with eighteen years research and consultancy experience. She was carer for her sister who died of melanoma in August 2014. Presently she is enrolled as patient advocate into the EUPATI – European Expert Training Course for Patients and Patient Representatives on the Medicines Research & Development. She set up recently an website and a Facebook page for the Romanian patients, targeting evidence based education on latest melanoma treatments and clinical trials. She is also acting as melanoma advocate within the core group of Melanoma Patient Network Europe, volunteering for Stichting Melanoom Netherlands and is the founder of the patients group Melanom Romania http://www.melanomromania.com

PATIENT EXPERT TRAINING COURSE MPNE Brussels 24-26 April 2015

Violeta Astratinei Roald Nystad

European Patients' Academy on Therapeutic Innovation q A patient-centered project of 30 organizations !

• patient organizations • universities • non-profit organizations - expert in patient and public engagement • European pharmaceutical companies

q Main project goal - to educate and facilitate patient involvement in R&D of drugs q Knowledge – Influence - Decision

A very popular Training Course

300 persons from whole Europe applied!

55 trainees taken onboard 24 different countries in Europe

Upon completion of the course, trainees will get the knowledge to: •  become qualified partners in medicines research and development to improve patient outcomes.

EUPATI PATIENT EXPERT TRAINING

q Course consist in •

independent e-learning

•

two training sessions in Barcelona

q Duration: • October 2014 until December 2015 • 250 hours of e-learning study • 10 days face to face meetings

EUPATI PATIENT EXPERT TRAINING Start: October 2014 End: December 2015

EUPATI Patient Expert Training Course MODULE 1: Discovery of Medicines and Planning of Medicines Development MODULE 2: Non-Clinical Testing and Pharmaceutical Development MODULE 3: Exploratory and Confirmatory Clinical Development MODULE 4: Clinical Trials

MODULE 5: Regulatory Affairs, Pharmacovigilance and Pharmacoepidemiology MODULE 6: Health Technology Assessment (HTA) principles and practices

EUPATI Patient Expert Training Course

BARCELONA: q 29 March-2 April 2015 - evidence-based medicine, clinical methodology, statistics, ethics, marketing authorisation, the European Medicines’ Agency (EMA)

FACE TO FACE MEETINGS!

q 14-18 September 2015 - risk/benefit of medicines and health technology assessment.

EUPATI Patient Expert Training Course AREAS of APLICATION: 1.  Patient Representation: by interacting with scientific committees, Health Technology Assessment agencies, industry, regulatory bodies, academia and other relevant stakeholders.

2. Communication: raising awareness on patient involvement in medicines R-D: articles and press releases; press conferences cooperation with media; TV and radio programs; social networks and blogs.

3. Education/formation: dissemination of the acquired education on medicine R-D: training to patient advocates; leading workshops; running information sessions for people interested in participating in clinical trials

Quality of EUPATI material

Impartial Evidence based Up to date Reliable Understandable Transparent Patient-oriented Relevant

After 6 months study § Studied 4 out of 6 modules, total 34 lessons § Took 34 tests after each lesson § Wrote 10 short esays § Performed 2 exams § Participated in 6 webinars § Participated to the 1st seminar in Barcelona § 46 students, 21 countries, in total 80 participants § mix of intensive sessions and group exercises sessions § expert speakers - patient organizations, academia, pharma, industry or regulators § UK, Germany, Spain, France, Netherlands, Belgium, Italy, Denmark and Hungary.

Start making things happen – EUPATI in ROMANIA! Medical Journals

Stakeholder database

Press agencies Conferences Workshops Trainings Meetings

Facebook group

From now till December 2015 2 more modules to repeat 2 more modules to be studied 1 more seminar 4 more exams

Over 40 lessons Over 40 tests Over 15 essays

EUPATI Patient Expert Training Course EVALUATION: q Tests at the end of each lesson q Multiple-choice assessments to the end of each module – EXAM 70% q

Active participation to the face to face events – ask questions, do comments, analyze documents, articles, protocol and to the online forum (reflective questions); CERTIFICATION:

q Official certificate upon successful completion Eupati Training Course q Organizations/institutes/companies recognize the certificate.

Excellent training!

Excellent networking!

Excellent teambuilding! J

Do you know what "Eupa/" poten/ally means in Greek?

The EU "ef" in any Greek word means "good“.

1st Eupa) in my Greek eyes means ‘’the first good road".

A really great name for a great cause!

Victoria Fonsou, Greece, Eupa2 student

MPNE 2015- The risk of NOT taking risks in Melanoma

5.6 How to make the MPNE network work- our communication strategy.

Lori Murdoch, Melanoma Network UK founder, patient advocate and Stage IV Melanoma patient, UK ‘I am a 59 year old mother of three beautiful, healthy, happy, successful children and a retired solicitor and university law lecturer. I paint seascapes and vibrant abstracts and I am a passionate sailor. I am the owner of a small black and white terrier who hates everyone save for her family and friends whom she totally adores.

I am fortunate enough to live on a beautiful river where I keep my small yacht, Panache and I love to sail the south coast of England and meander up the many gorgeous rivers in my bilge keeler.

I am also a stage IV melanoma patient with a life expectancy of a few months. Over the summer of 2013 and 2014 I sailed around the UK in an old leaky wooden yacht to raise awareness of mm and money for local charities. I recently set up Melanoma Network UK on Facebook to disseminate information about melanoma and I am a keen patient advocate.’ Watch Lori’s story

How to make the MPNE network work Our communica+on strategy Lori Murdock Melanoma Network UK

Discussion group The ideas contained in these slides are designed to trigger thought, discussion and an ongoing dialogue-­‐it is by no means a definiCve list

Lori Murdock

MPNE2015

CommunicaCng knowledge empowers paCents • A diagnosis of melanoma can make a paCent feel isolated and thirsty for knowledge • InformaCon is power and offers choice • The internet is full of informaCon. How do we use it? Easy to feel overwhelmed • Our strategy: reviewing what MPNE has achieved • What could be added?

• The concept of local to global Lori Murdock

MPNE2015

Fabulous site: how do we make it more visible?

• Personal recommendaCon • Search engine opCmisaCon. PosCng links elsewhere will bring MPNE up search engine rankings • Links from naConal sites • Use of media

Lori Murdock

MPNE2015

CommunicaCon: local to global MPNE website -­‐ • Search engine links • Newly-­‐diagnosed paCents • Inclusion in informaCon packs given out by hospitals • Leaflets in clinics

Lori Murdock

MPNE2015

MPNE contains a lot of informaCon but what could be added?

• Different types of melanoma • Understanding your pathology • Great referencing ‘not reinvenCng the wheel’ Links to other sites either on a naConal or internaConal level • Centres of melanoma excellence naConally and internaConally • Finding the right doctor

MPNE2015 Lori Murdock

MPNE contains a lot of informaCon but what could be added?

• More on prevenCon and self-­‐examinaCon • InformaCon specific to recently diagnosed paCents • Standard surgery procedures explained • Carer support • Financial support • Don’t see what you want? What else do you need?

Lori Murdock

MPNE2015

Do we need a paCent/carer forum?

What exists?

• Facebook • Melanoma InternaConal FoundaCon • Macmillan • Melanoma.org • Language-­‐specific?

• Good way to idenCfy common problems/gaps in knowledge

Lori Murdock

MPNE2015

MPNE 2015- The risk of NOT taking risks in Melanoma

5.7 Knowledge is power- our education strategy.

Gilly Spurrier, MelanomeFrance, France Gilly is the founder and driving force behind MĂŠlanome France and spouse to a Melanoma Stage 4 patient.

Gilly is passionate about Patient Empowerment - French Melanoma Patients are under-represented in Europe and have difficulty in accessing relevant information if they don’t speak English.

She strongly believes that Patients are the main stakeholders in their own health and in the fight for equality of care and that they need help to get informed.

She therefore set up MelanomeFrance in 2014 and currently runs the forum, website and admin of the organisation and will do pretty much anything it takes to get patients access to treatments and clinical trials and to help them feel equal partners in their therapy!

www.melanomefrance.com

KNOWLEDGE IS POWER : EDUCATING PATIENT ADVOCATES MPNE Educa9on strategy Gilliosa Spurrier Mélanome France

Gilliosa Spurrier-­‐ Mélanome France-­‐@MelanomFrance

WHY ?

KNOW YOUR ENEMY : MELANOMA, THE SCIENCE AND THE SYSTEM

EVERYONE ELSE HAS AN AGENDA OR A STAKE HOLD : ONLY OURS IS LIFE OR DEATH

KNOW YOUR FRIENDS : MANY MORE THAN YOU WOULD THINK !

MPNE2015 Gilliosa Spurrier

HOW ?

• Get to know the health system in your country : who does what and why – know their responsibiliPes, accessibility and their moPvaPons and use them.

• Who makes the decisions and how they are made.

• Ask the people who know : established effecPve paPents organizaPons Industry, health policy people, clinicians : some will help , use them.

• Ask Each other : FORUMS-­‐ we know that paPent Forums contain Experts in every field and they share our goals and headaches.

• Know who are the movers and shakers in each field • Know the Language : ACRONYMS and TERMINOLOGY – Glossary -­‐ medicaPons and treatments • USE the opportuniPes offered – take up the offers of training , parPcipaPon seminars and conferences • Ask for free entry to events and conferences – if you don’t ask you don’t get • Show willing, ask everyone and say what you don’t know and people will give you informaPon

Gilliosa Spurrier

MPNE2015

WHERE ?

Online : sign up for alerts, mailing lists, newsleZers – its free Don’t re-­‐invent the wheel : look at what other paPents groups/consumer groups/research groups do and adapt it Know your way around the trials databases : they tell you a lot more than what and where.

Forums : PaPents will tell you like it is – they will show you the real prioriPes. Everyone who knows more than you !

Gilliosa Spurrier

MPNE2015

ONCE YOU KNOW : SHARE • • • • • • •

Forums, mailing list, Facebook, TwiZer Network Respect privacy and Permissions Be truthful and frank Look out for each others backs Co-­‐operate You cant do everything Gilliosa Spurrier

MPNE2015

ADVOCACY “Never doubt that a small group of thoughtful, committed citizens can change the world; indeed, it's the only thing that ever has”

(Margaret Mead – renowned anthropologist and first class grumpy old woman !)

Gilliosa Spurrier

MPNE2015

That’s why we do it-­‐ A Norwegian mother to 4 children 4 months, 2, 4 and 6 years old advised 2 hours ago

Gilliosa Spurrier

MPNE2015

Topics to come up in MPNE 2015/2016 Pre-­‐conference priming Workshops KrisPn’s Glossary, EupaP, Events LisPngs Accessible/searchable informaPon and research database Network DELEGATE !!

MPNE2015 Gilliosa Spurrier

MPNE 2015- The risk of NOT taking risks in Melanoma

Thank you We thank our speakers for contributing to the success of this conference, their commitment to MPNE and for sharing their slides.

Feel free to share but please acknowledge the rightful authors!

Melanoma Patient Network Europe www.melanomapatientnetworkeu.org

MPNE 2015 The risk of not taking risks in Melanoma.

24th- 26th April 2015, Brussels, Belgium