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#175 Empowerment and participation of women within clinical trials (EMPACT): a research program protocol in gynaecologic oncology
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  1. Sara Nasser1,2,
  2. Esra Bilir2,3,4,
  3. Andreas Kaufmann1,
  4. Andreas Ullrich1 and
  5. Jalid Sehouli1,2
  1. 1Department of Gynecology with Center of Oncological Surgery, Charite Global Health Center, Charite Universitatsmedizin Berlin, Berlin, Germany
  2. 2Pan-Arabian Research Society of Gynecological Oncology, Berlin, Germany
  3. 3Department of Obstetrics and Gynaecology, Die Klinik in Preetz, Preetz, Germany
  4. 4Department of Gynecologic Oncology, Koc University School of Medicine, Istanbul, Türkiye

Abstract

Introduction/Background Emerging data on the gynaecologic oncology publications based on income level revealed unproportioned contributions and leadership from the high-income level countries (HILC). Our aim is to identify determinants and barriers to the access to clinical trials and research activities among patients presenting to the gynaecology clinics in low- and middle-income countries (LMIC) and among healthcare professionals (HCP) with particular focus on female staff. We share our protocol and early collaborative results within the Empowerment and Participation of Women within Clinical Trials (EMPACT) project.

Methodology EMPACT project builds on the successful and well-established trans-African digital health network project (i-STARC). i-STARC Project built the foundations of a solid trans-African digital network for educational exchange. Its focus was interdisciplinary virtual tumour boards and interactive webinars. Our experience showed further the need of establishing research education programs involving HCP and the patients with gynaecologic cancers. We designed an exploratory mixed-method study with the goals of capturing and analysing significant themes and experiences as well as barriers and desires from the perspective of patients and healthcare staff.

Results We established collaborations between Morocco, Egypt, and Tanzania. Non-academic partners from local civil societies, Ministries of Health and World Health Organisation country offices in these countries, and international partners (e.g., Gynecological Cancer Intergroup, European Network for Gynaecological Oncology Trials) play a constitutional role in research. Our mixed method study includes coaching in research programs, patient advocate training program, good-clinical practice certification, implementation research, scientific writing, and focus-group interviews. The effectiveness of these interventions will be tested via multiple focus group assessments with surveys and interviews within 18 months after completion of the data collection and education phases.

Conclusion The core of EMPACT project is our strong transdisciplinary concept and involvement of HCP and patients. We will implement our research protocol to embrace the equity in LMICs.

Disclosures None

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