A trial-ready cohort for finding unmet needs and improving quality of life among patients with esophageal cancer: A multicenter prospective cohort study

Jiyoon Han^1,2Genehee Lee^3,4Juhee Cho^1,2,5Somin You^1,2Young Mog Shim^3,4Yong Soo Choi³Jong Ho Cho³Seong Yong Park³Yeong Jeong Jeon³Junghee Lee³Danbee Kang^1,2*Hong Kwan Kim^3,4*

• ¹Department of Clinical Research Design and Evaluation, Samsung Advanced Institute for Health Sciences & Technology, Sungkyunkwan University, Gangnam-gu, Seoul, Republic of Korea
• ²Center for Clinical Epidemiology, Samsung Medical Center, Seoul, Republic of Korea
• ³Department of Thoracic and Cardiovascular Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
• ⁴Patient-Centered Outcomes Research Institute, Samsung Medical Center, Seoul, Republic of Korea
• ⁵Department of Health, Behavior and Society, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, United States

Although esophageal cancer survivors experience lower health-related quality of life (HRQoL), it is hard to provide proper supportive care due to difficulties to find potential target population. This study aims to develop a trial-ready cohort (TRC) to assess the unmet needs and HRQoL of survivors of esophageal cancer. This prospective, multicenter TRC study will include 600 patients diagnosed with primary esophageal cancer who have undergone curative treatment. Exclusion criteria include the presence of synchronous malignancies, severe cognitive impairment, and residence outside of Korea. Patients are recruited from both existing cohort studies and newly diagnosed cases beginning in June 2023. At the time of enrollment into the TRC, participants provide informed consent, including agreement to be contacted and considered for relevant clinical trials when suitable interventions become available. Data is collected across five domains: sociodemographic characteristics, health behaviors, disease and treatment information, nutritional status, and quality of life. Study visits are scheduled at diagnosis, prior to surgery, at 1, 3, 6, and 12 months post-surgery, and annually thereafter for up to 10 years. As of June 2025, a total of 448 participants have been enrolled, representing approximately 75% of the target. To achieve this, our TRC employs three key strategies. First, we leverage three existing prospective studies to efficiently identify and enroll longterm survivors. Second, we collect a wide range of data on HRQoL, health behaviors, and environmental factors to enable a multidimensional understanding of survivorship. Third, we collect multiple times within short-term interval points, allowing seamless linkage between the cohort and appropriate trials. This study effectively designs a trial-ready cohort of survivors of esophageal cancer using a unique strategy to overcome cohort construction challenges, aiming to generate valuable data on quality of life and serve as a platform for tailored interventions.