Article Text
Abstract
Introduction/Background Routine follow-up for patients treated for gynecological malignancies aims to detect early recurrence, provide support and to evaluate treatment related morbidity and mortality. Evidence-based follow-up strategies are still lacking and the effectiveness of routine follow-up procedures in terms of survival and quality of life needs to be redefined. The main objective of this project is to determine the range and prevalence of physical, psychological and social problems following gynecologic cancer treatment, to evaluate the impact of gynecologic cancer and its treatment on quality of life and to identify patterns of physical, psychological and social problems based on demographic and clinical factors.
Methodology The EORTC 1514-QLG-GCG is an international cross-sectional non-interventional follow-up study in patients who are disease-free at least 6 months but no more than 5 years since completion of primary treatment for cervical, endometrial, ovarian (including fallopian tube and peritoneal primary) or vulvar cancer. Institutional data, demographic data, tumour characteristics, treatment history and comorbidities are collected. The patient is required to complete a questionnaire set including the EORTC QLQ-C30, OUT-PATSAT-C7, QLQ-SHQ22 and Distress Thermometer, totalling 76 questions. A total of 1100 patients is expected to be enrolled, allowing estimation of prevalence rates with a 95% confidence interval no wider than 3% and 95% power to detect a 10% difference between two cohorts. Patients will be stratified by cancer site (ovarian; cervical; endometrial; vulvar) and treatment (Surgery only; Surgery + Radiotherapy; Surgery + Chemotherapy; Chemotherapy + Radiotherapy w/o surgery).
Results As of May 2022, the trial has recruited 960 patients from 21 institutions and is expected to complete recruitment by end of 2022.
Conclusion Information gained from this project will be useful for redefining follow-up programs including objective outcomes such as late adverse treatment effects as well as subjective outcomes such as patients’ psychosocial distress and quality of life.