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| Name | Class |
|---|---|
| BROSTCANCERFORENINGEN AMAZONA I STOCKHOLMS LAN | UNKNOWN |
| Karolinska Institutet | OTHER |
| Instituto de Investigacion Sanitaria INCLIVA | OTHER |
| FUNDACION PARA LA INVESTIGACION DEL HOSPITAL CLINICO DE LA COMUNITAT VALENCIANA, FUNDACION INCLIVA |
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Breast cancer (BC) is the most commonly diagnosed cancer in women worldwide, with early-onset cases increasing due to genetic and lifestyle factors. Traditional prevention strategies have shown limited effectiveness, creating the need for innovative approaches. The MELIORA project develops an AI-driven digital tool, the Virtual Coach (VC), to promote sustainable behaviour change in physical activity, diet, and alcohol use. Three randomized-controlled studies will be conducted: MELIORA-HEALTHY (women at risk, n=1080 in Greece, Lithuania, Spain), MELIORA-PATIENTS (women undergoing treatment, n=400 in Lithuania, Spain), and MELIORA-SURVIVORS (post-treatment survivors, n=600 in Lithuania, Spain, Sweden). Participants across diverse regions and backgrounds will be randomized to standard lifestyle advice or the same advice plus the MELIORA VC app. Each study lasts 12 months, with outcomes assessed at baseline, 6, and 12 months. The primary outcome is physical activity, with secondary outcomes including sedentary behaviour, diet, alcohol use, and quality of life. If effective, the MELIORA VC could offer a scalable, cost-effective model for BC prevention and survivorship care, providing valuable evidence to guide public health strategies.
Breast cancer (BC) is the most commonly diagnosed cancer among women worldwide, with early-onset cases rising rapidly due to interactions between genetics and lifestyle behaviours. Traditional efforts to modify these behaviours have had limited success, highlighting the need for innovative, multifaceted approaches. The Multimodal Engagement and Sustainable Lifestyle Interventions Optimizing Breast Cancer Risk Reduction Supported by Artificial Intelligence (MELIORA) project addresses this gap by promoting sustainable behaviour change through an innovative intervention using artificial intelligence (AI). The project will develop and evaluate an AI-driven behaviour change digital solution, the MELIORA virtual coach (VC), designed to enhance awareness, motivation, and promote healthier lifestyle choices related to physical activity, diet, and alcohol consumption, while addressing potential implementation barriers.
The MELIORA VC intervention consists of three separate studies: 1) the MELIORA-HEALTHY Study targeting healthy women at risk of BC (conducted in Greece, Lithuania, Spain), 2) the MELIORA-PATIENTS Study targeting BC patients (conducted in Lithuania, Spain), and 3) the MELIORA-SURVIVORS Study targeting BC survivors (conducted in Lithuania, Spain, Sweden), involving a total of 2,080 participants. The studies will encompass both urban and rural regions and will include participants across the socioeconomic spectrum and/or ethnic minority groups, allowing for the evaluation of how these factors moderate the effectiveness of the MELIORA behavioural change intervention. The studies will follow a randomized-controlled design. For the MELIORA-HEALTHY study, a total of 1080 adult women (360 per site), free of cancer and with at least one behavioural (i.e. low levels of physical activity, unhealthy diet, increased alcohol consumption) or metabolic (i.e. increased BMI) risk factor will be recruited. For the MELIORA-PATIENTS study, a total of 400 adult women diagnosed with BC and currently undergoing treatment (200 per site) will be recruited. For the MELIORA-SURVIVORS study, a total of 600 adult women diagnosed with BC and have completed primary therapy (200 per site) will be recruited.
Participants at each site will be randomly assigned (1:1 allocation) to either the intervention group or the control group. The control group will receive the standard of care that is generic advice for a healthy lifestyle and BC prevention. The intervention group will receive the same generic advice along with the MELIORA VC intervention app. The total study duration for each participant will be 12 months, divided into two six-month periods: the intervention period and the follow-up period. Targeted behaviours will be assessed at three time points: baseline (0 months), end of the six-month intervention period (6 months), and end of the six-month follow-up period (12 months). The primary outcome that will be assessed is physical activity while secondary outcomes include sedentary behaviours, diet, alcohol consumption and health-related quality of life.
The MELIORA project represents an innovative approach to BC prevention by integrating an AI-driven digital health solution into real-world settings. The MELIORA studies highlight the role of technology in promoting sustainable behaviour change to prevent the onset or recurrence of BC. The VC tool that will be developed, tested and evaluated is a key outcome of the MELIORA project and aims to support preventive policies and health promotion guidelines for BC prevention. If successful, the MELIORA VC model could be expanded to other at-risk populations, reinforcing the potential of AI-driven, cost-effective health interventions in cancer prevention. Findings will provide valuable insights for policymakers and healthcare professionals on the feasibility, effectiveness, and cost-effectiveness of AI-supported lifestyle interventions, shaping future public health strategies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MELIORA Virtual Coach Intervention (VCI) Group | Experimental | The intervention group will receive generic advice on a healthy lifestyle and breast cancer (BC) prevention plus access to the full MELIORA VCI app. |
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| Control Group | Placebo Comparator | The control group will receive the standard of care that is generic advice for a healthy lifestyle and BC prevention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MELIORA Virtual Coach Intervention | Behavioral | Based on baseline assessments, the MELIORA VCI app will prompt intervention group participants to set weekly goals on lifestyle behaviours such as physical activity, diet, alcohol use, and sedentary time, and support daily self-monitoring and step count tracking. Goals will be dynamically adjusted by the virtual coach or the participant to remain realistic and achievable. Τhe app will also offer culturally adapted educational, motivational, and instructional support through mini-courses, tips, recommendations and an embedded library of relevant materials to ensure high adoption rates among women from diverse countries, socioeconomic backgrounds and minority groups. To boost motivation, it will include reminders, gamification features like badges and points, as well as personalized techniques such as action planning, problem solving, social reward, and positive self-talk. |
| Measure | Description | Time Frame |
|---|---|---|
| Physical activity levels - MVPA minutes | The primary outcome will be the mean change in physical activity levels as measured by MVPA minutes from baseline at the end of the six-month intervention period between the intervention and the control group. | From baseline (T0) until the end of the six-month intervention period (T1) |
| Physical activity levels - Step count | The primary outcome will be the mean change in physical activity levels as measured by step count from baseline at the end of the six-month intervention period between the intervention and the control group. | From baseline (T0) until the end of the six-month intervention period (T1) |
| Measure | Description | Time Frame |
|---|---|---|
| Physical activity levels - MVPA minutes | Mean changes in physical activity levels as measured by MVPA minutes, from baseline until the end of the 6-month intervention period, within groups. | From Baseline (T0) until the end of the six-month intervention period (T1) |
| Physical activity levels - MVPA minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Body mass index (BMI) | Mean changes in BMI, from baseline until the end of the 6-month intervention period and until the end of the 6-month follow-up period, within and between groups. | From Baseline (T0) until the end of the six-month intervention period (T1) and from T0 until the end of the 6-month follow-up period (T2) |
Inclusion Criteria:
MELIORA-HEALTHY study participants must meet all of the following criteria in order to be deemed eligible for study participation:
MELIORA-PATIENTS study participants must meet all of the following criteria in order to be deemed eligible for study participation:
MELIORA-SURVIVORS study participants must meet all of the following criteria in order to be deemed eligible for study participation:
Exclusion Criteria:
MELIORA-HEALTHY study participants will be excluded from study participation if they meet any of the following criteria:
MELIORA PATIENTS and MELIORA SURVIVORS study participants will be excluded from study participation if they meet any of the following criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yannis Manios, Professor | Contact | +30 2109549156 | manios@hua.gr |
| Name | Affiliation | Role |
|---|---|---|
| Yannis Manios, Professor | Department of Nutrition and Dietetics, School of Health Science & Education, Harokopio University, Athens, Greece | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harokopio University | Recruiting | Athens | Greece |
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| Label | URL |
|---|---|
| MELIORA website link | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| UNKNOWN |
| LIETUVOS SVEIKATOS MOKSLU UNIVERSITETAS | UNKNOWN |
| PAGALBOS ONKOLOGINIAMS LIGONIAMS ASOCIACIJA | UNKNOWN |
| SWPS UNIWERSYTET HUMANISTYCZNOSPOLECZNY | UNKNOWN |
| EUROPEAN FOOD INFORMATION COUNCIL | UNKNOWN |
| PredictBy Research and Consulting, S.L | INDUSTRY |
| ETHNIKO KENTRO EREVNAS KAI TECHNOLOGIKIS ANAPTYXIS | UNKNOWN |
| EXUS SOFTWARE MONOPROSOPI ETAIRIA PERIORISMENIS EVTHINIS | UNKNOWN |
| RISA SICHERHEITSANALYSEN GMBH | UNKNOWN |
| BioAssist | INDUSTRY |
| EUROPEAN HEALTH MANAGEMENT ASSOCIATION | UNKNOWN |
| ETICAS DATA SOCIETY | UNKNOWN |
The MELIORA RCTs will employ a parallel-group, randomized controlled design with two groups: an intervention group and a control group. The study follows a superiority design, with individual-level randomization and a 1:1 allocation ratio.
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| Control (generic advice) | Other | The control group will receive the standard of care that is generic advice for a healthy lifestyle and BC prevention. A 'light' version of the MELIORA VCI app will be developed to host the control group materials, track participants' step counts, send reminders, and allow scheduling of follow-up visits. No other features will be available in this version of the app. |
|
Mean changes in physical activity levels as measured by MVPA minutes, from baseline until the end of the 6-month follow-up period between groups. |
| From Baseline (T0) until the end of the 6-month follow-up period (T2) |
| Physical activity levels - MVPA minutes | Mean changes in physical activity levels as measured by MVPA minutes, from baseline until the end of the 6-month follow-up period within groups. | From Baseline (T0) until the end of the 6-month follow-up period (T2) |
| Physical activity levels - Step count | Mean changes in physical activity levels as measured by step count, from baseline until the end of the 6-month intervention period, within groups. | From Baseline (T0) until the end of the six-month intervention period (T1) |
| Physical activity levels - Step count | Mean changes in physical activity levels as measured by step count, from baseline until the end of the 6-month follow-up period, between groups. | From Baseline (T0) until the end of the 6-month follow-up period (T2) |
| Physical activity levels - Step count | Mean changes in physical activity levels as measured by step count, from baseline until the end of the 6-month follow-up period, within groups. | From Baseline (T0) until the end of the 6-month follow-up period (T2) |
| Aerobic exercise minutes | Mean changes in aerobic exercise minutes, from baseline until the end of the 6-month intervention period between groups. | From Baseline (T0) until the end of the six-month intervention period (T1) |
| Aerobic exercise minutes | Mean changes in aerobic exercise minutes, from baseline until the end of the 6-month intervention period, within groups. | From Baseline (T0) until the end of the six-month intervention period (T1) |
| Aerobic exercise minutes | Mean changes in aerobic exercise minutes, from baseline until the end of the 6-month follow-up period, between groups. | From Baseline (T0) until the end of the 6-month follow-up period (T2) |
| Aerobic exercise minutes | Mean changes in aerobic exercise minutes, from baseline until the end of the 6-month follow-up period, within groups. | From Baseline (T0) until the end of the 6-month follow-up period (T2) |
| Muscle strengthening minutes | Mean changes in muscle strengthening minutes, from baseline until the end of the 6-month intervention period within groups. | From Baseline (T0) until the end of the six-month intervention period (T1) |
| Muscle strengthening minutes | Mean changes in muscle strengthening minutes, from baseline until the end of the 6-month intervention period between groups. | From Baseline (T0) until the end of the six-month intervention period (T1) |
| Muscle strengthening minutes | Mean changes in muscle strengthening minutes, from baseline until the end of the 6-month follow-up period, within groups. | From Baseline (T0) until the end of the 6-month follow-up period (T2) |
| Muscle strengthening minutes | Mean changes in muscle strengthening minutes, from baseline until the end of the 6-month follow-up period, between groups. | From Baseline (T0) until the end of the 6-month follow-up period (T2) |
| Sedentary minutes | Mean changes in sedentary minutes, from baseline until the end of the 6-month intervention period between groups. | From Baseline (T0) until the end of the six-month intervention period (T1) |
| Sedentary minutes | Mean changes in sedentary minutes, from baseline until the end of the 6-month intervention period within groups. | From Baseline (T0) until the end of the six-month intervention period (T1) |
| Sedentary minutes | Mean changes in sedentary minutes, from baseline until the end of the 6-month follow-up period, within groups. | From Baseline (T0) until the end of the 6-month follow-up period (T2) |
| Sedentary minutes | Mean changes in sedentary minutes, from baseline until the end of the 6-month follow-up period, between groups. | From Baseline (T0) until the end of the 6-month follow-up period (T2) |
| Αlcohol consumption | Mean changes in alcohol consumption (servings/week), from baseline until the end of the 6-month intervention period within groups. | From Baseline (T0) until the end of the six-month intervention period (T1) |
| Αlcohol consumption | Mean changes in alcohol consumption (servings/week), from baseline until the end of the 6-month intervention period between groups. | From Baseline (T0) until the end of the six-month intervention period (T1) |
| Αlcohol consumption | Mean changes in alcohol consumption (servings/week), from baseline until the end of the 6-month follow-up period, within groups. | From Baseline (T0) until the end of the 6-month follow-up period (T2) |
| Αlcohol consumption | Mean changes in alcohol consumption (servings/week), from baseline until the end of the 6-month follow-up period, between groups. | From Baseline (T0) until the end of the 6-month follow-up period (T2) |
| Diet quality | Mean changes in rapid Prime Diet Quality Score Screener (rPDQS) diet score (0-26 points with higher scores meaning a better diet quality) and individual dietary components, from baseline until the end of the 6-month intervention period within groups. | From Baseline (T0) until the end of the six-month intervention period (T1) |
| Diet quality | Mean changes in rapid Prime Diet Quality Score Screener (rPDQS) diet score (0-26 points with higher scores meaning a better diet quality) and individual dietary components, from baseline until the end of the 6-month intervention period between groups. | From Baseline (T0) until the end of the six-month intervention period (T1) |
| Diet quality | Mean changes in rapid Prime Diet Quality Score Screener (rPDQS) diet score (0-26 points with higher scores meaning a better diet quality) and individual dietary components, from baseline until the end of the 6-month follow-up period, within groups. | From Baseline (T0) until the end of the 6-month follow-up period (T2) |
| Diet quality | Mean changes in diet score and individual dietary components, from baseline until the end of the 6-month follow-up period, between groups. | From Baseline (T0) until the end of the 6-month follow-up period (T2) |
| Health-related quality of life | Mean changes in quality of life [EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L, scale 1-5 with greatest values meaning worst outcomes)] , from baseline until the end of the 6-month intervention period within groups. | From Baseline (T0) until the end of the six-month intervention period (T1) |
| Health-related quality of life | Mean changes in quality of life [EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L, scale 1-5 with greatest values meaning worst outcomes)], from baseline until the end of the 6-month intervention period between groups. | From Baseline (T0) until the end of the six-month intervention period (T1) |
| Health-related quality of life | Mean changes in quality of life [EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L, scale 1-5 with greatest values meaning worst outcomes)], from baseline until the end of the 6-month follow-up period, within groups. | From Baseline (T0) until the end of the 6-month follow-up period (T2) |
| Health-related quality of life | Mean changes in quality of life [EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L, scale 1-5 with greatest values meaning worst outcomes)], from baseline until the end of the 6-month follow-up period between groups. | From Baseline (T0) until the end of the 6-month follow-up period (T2) |
| Role modelling behaviours |
Mean changes in role modelling behaviours, from baseline until the end of the 6-month intervention period and until the end of the 6-month follow-up period, within and between groups. An eleven-item tool was developed specifically for the purpose of this research to assess the potential impact of the intervention on health behaviours of participants' daughters. These items assess mothers' efforts to inform their daughter(s) about their participation in the intervention, to practise health behaviours in front of or along with their daughter(s), and to motivate their daughter(s) to also improve their health behaviours, as well as the perceived effect of mothers' participation on the daughter(s)' eating habits, physical activity, sedentary behaviour, alcohol consumption, and health literacy. |
| From Baseline (T0) until the end of the six-month intervention period (T1) and from T0 until the end of the 6-month follow-up period (T2) |
| Health literacy | Mean changes in health (European Health Literacy Survey Questionnaire (HLS-EU-Q) using 4-point Likert scales ranging from 1 = very easy to 4 = very difficult) from baseline until the end of the 6-month intervention period and until the end of the 6-month follow-up period, within and between groups. | From Baseline (T0) until the end of the six-month intervention period (T1) and from T0 until the end of the 6-month follow-up period (T2) |
| e-health literacy | Mean changes in e-health literacy (modified version of the Application subscale of the eHealth Literacy Scale in Web 3.0 context (eHLS Web 3.0) that uses 5-point Likert scales ranging from 1 = strongly disagree to 5 = strongly agree) from baseline until the end of the 6-month intervention period and until the end of the 6-month follow-up period, within and between groups. | From Baseline (T0) until the end of the six-month intervention period (T1) and from T0 until the end of the 6-month follow-up period (T2) |
| Psychosocial parameters - Physical capability | Mean changes in physical capability, from baseline until the end of the 6-month intervention period and until the end of the 6-month follow-up period, within and between groups. Physical capability will be measured with a modified version of the physical competence subscales of the Physical Literacy in Adults Scale (PLAS), which assess one's perceived physical strength (3 items) and coordination/ balance (3 items) using 7-point Likert scales ranging from 1 = very untrue to 7 = very true. | From Baseline (T0) until the end of the six-month intervention period (T1) and from T0 until the end of the 6-month follow-up period (T2) |
| Psychosocial parameters - Psychological capability | Mean changes in psychological capability, from baseline until the end of the 6-month intervention period and until the end of the 6-month follow-up period, within and between groups. A 6-item scale developed by Sniehotta, Scholz, & Schwarzer (2005) and later adapted by Willmott, Pang, & Rundle-Thiele (2021) will be used to assess the extent to which participants tried to self-monitor their physical activity behaviour (i.e., action control) in the last four weeks using 7-point Likert scales ranging from 1 = very untrue to 7 = very true. | From Baseline (T0) until the end of the six-month intervention period (T1) and from T0 until the end of the 6-month follow-up period (T2) |
| Psychosocial parameters - Psychological capability | Mean changes in psychological capability, from baseline until the end of the 6-month intervention period and until the end of the 6-month follow-up period, within and between groups. A10-item scale (Sniehotta, Schwarzer, Scholz, & Schüz, 2005) will be employed to assess the extent to which participants have planned when, where, how often, and how to engage in physical activity (i.e., action planning, 4 items) as well as how to overcome potential barriers for being physically active (i.e., coping planning, 6 items) using 4-point Likert scales ranging from 1 = completely disagree to 4 = totally agree. | From Baseline (T0) until the end of the six-month intervention period (T1) and from T0 until the end of the 6-month follow-up period (T2) |
| Psychosocial parameters - Social support for physical activity | Mean changes in social support for physical activity, from baseline until the end of the 6-month intervention period and until the end of the 6-month follow-up period, within and between groups. Social support for physical activity will be measured with the Exercising together subscale (5 items) of the Social Support for Exercise Behaviour Scale (SSEBS) (Sallis, Grossman, Pinski, Patterson, & Nader, 1987), as used in Howlett, Schulz, Trivedi, Troop, & Chater (2019). Specifically, participants will indicate how often their friends and family members supported them in being physically active during the past three months using 5-point Likert scales ranging from 1 = none to 5 = very often. | From Baseline (T0) until the end of the six-month intervention period (T1) and from T0 until the end of the 6-month follow-up period (T2) |
| Psychosocial parameters - Reflective motivation | Mean changes in reflective motovation, from baseline until the end of the 6-month intervention period and until the end of the 6-month follow-up period, within and between groups. The 5-item self-efficacy for physical activity scale by Marcus, Selby, Niaura, & Rossi (1992) will be used to assess participants' confidence in their ability to perform physical activity under various challenging circumstances. The measurement instrument uses 5-point Likert scales ranging from 1 = not confident at all to 5 = extremely confident and has been extensively used in prior research to assess self-efficacy for physical activity. | From Baseline (T0) until the end of the six-month intervention period (T1) and from T0 until the end of the 6-month follow-up period (T2) |
| Psychosocial parameters - Automatic motoivation | Mean changes in automatic motivation, from baseline until the end of the 6-month intervention period and until the end of the 6-month follow-up period, within and between groups. The International Positive and Negative Affect Schedule Short Form (I-PANAS-SF) (Thomson, 2007) will be used to assess positive (5 items) and negative (5 items) affective responses towards physical activity, as used in Willmott, Pang, & Rundle-Thiele (2021). The measurement instrument uses 5-point Likert scales ranging from 1 = never to 5 = always to assess to what extent an individual generally feels positive and negative emotions about physical activity. | From Baseline (T0) until the end of the six-month intervention period (T1) and from T0 until the end of the 6-month follow-up period (T2) |
| Psychosocial parameters - Injunctive social norms for physical activity | Mean changes in injunctive social norms for physical activity, from baseline until the end of the 6-month intervention period and until the end of the 6-month follow-up period, within and between groups. Injunctive social norms for physical activity will be assessed with two items developed by Courneya, Friedenreich, Arthur, & Bobick (1999), which measure the extent to which important others expect or support the individual to be physically active in the coming 4 months. | From Baseline (T0) until the end of the six-month intervention period (T1) and from T0 until the end of the 6-month follow-up period (T2) |
| Psychosocial parameters - Descriptive norms for physical activity | Mean changes in descriptive norms for physical activity, from baseline until the end of the 6-month intervention period and until the end of the 6-month follow-up period, within and between groups. Descriptive norms will be assessed with three items, measuring to what extent family, friends, and co-workers engage in physical activity themselves (Rhodes & Courneya, 2003). Both measurement instruments use 7-point Likert scales ranging from 1 = strongly disagree to 7 = strongly agree. | From Baseline (T0) until the end of the six-month intervention period (T1) and from T0 until the end of the 6-month follow-up period (T2) |
| Lietuvos Sveikatos Mokslų Universitetas (Lsmu) | Recruiting | Kaunas | Lithuania |
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| Pagalbos Onkologiniams Ligoniams Asociacija (Pola L T) | Recruiting | Kaunas | Lithuania |
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| Fundación Para El Fomento de La Investigación Sanitaria Y Biomédica de La Comunitat Valenciana (Fisabio) | Recruiting | Valencia | Spain |
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| INCLIVA - Instituto de Investigación Sanitaria | Recruiting | Valencia | Spain |
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| Bröstcancerföreningen Amazona I Stockholms Län (Amazona) | Recruiting | Stockholm | Sweden |
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| Karolinska Institutet | Recruiting | Stockholm | Sweden |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D001519 | Behavior |