Side effects screening and early intervention to impact in quality of life of patients with gynecological cancers (HALIS study)

Abstract

BackgroundAdvances in the treatment of gynecological cancers have led to increased survival in patients with gynecological cancers. Nevertheless, patients may still experience prevalent long term consequences, including lower limb lymphedema, depression, anxiety, sexual dysfunction, malnutrition, and sarcopenia, that negatively impact their quality of life.Primary ObjectiveTo assess the impact on self-perceived quality of life of systematic screening and early treatment of lower limb lymphedema, anxiety and depression, sexual dysfunction, and sarcopenia and malnutrition compared with standard practice.Study HypothesisSystematic screening with validated questionnaires leading to early diagnosis and treatment of side effects will have a positive impact on quality of life.Trial DesignThis prospective clinical trial will randomize candidates for surgery to either standard of care or systematic screening every 2 months for 2 years. Quality of life data will be collected every 4 months. After randomization, patients in the control group will follow standard usual care. Their screening scales will not be considered. In the experimental group, positive screenings will generate an alert to the physician, and patients will be referred to the corresponding specific area (rehabilitation unit, psycho-oncology unit, sexual health unit, or nutrition unit).Major Inclusion and xclusion CriteriaPatients aged ≥18 years with ovarian, cervical, or endometrial cancer who are candidates for surgery will be included.Primary EndpointSelf-reported quality of life questionnaire score.Sample Size168 patients will be randomized to detect a difference of 6 points in the questionnaires.Estimated Dates for Completing Accrual and Presenting ResultsStudy completion is estimated for January 2026 and the results will be presented in May 2026.Trial Registration numberNCT05918770.