Article Text

other Versions

Download PDFPDF
Side effects screening and early intervention to impact in quality of life of patients with gynecological cancers (HALIS study)
  1. Blanca Gil-Ibanez1,
  2. Alvaro Tejerizo-Garcia1,
  3. M Reyes Oliver1,
  4. Ainhoa Madariaga2,
  5. Maria Maiz Jimenez3,
  6. Alejandra Gil Garcia4 and
  7. Gregorio Lopez-Gonzalez1
  1. 1Gynecologic Oncology and Minimally Invasive Gynecologic Surgery Unit (Departament of Obstetrics and Gynecology), Hospital Universitario 12 de Octubre, Madrid, Spain
  2. 2Medical Oncology and Hematology, Hospital Universitario 12 de Octubre, Madrid, Spain
  3. 3Endocrinology and Nutrition Department, Hospital Universitario 12 de Octubre, Madrid, Spain
  4. 4Physical Medicine and Rehabilitation Department, Hospital Universitario 12 de Octubre, Madrid, Spain
  1. Correspondence to Dr Gregorio Lopez-Gonzalez, Gynaecologic Oncology, Hospital Universitario 12 de Octubre, Madrid, 28041, Spain; goyolopez2{at}hotmail.com

Abstract

Background Advances 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 Objective To 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 Hypothesis Systematic screening with validated questionnaires leading to early diagnosis and treatment of side effects will have a positive impact on quality of life.

Trial Design This 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 Criteria Patients aged ≥18 years with ovarian, cervical, or endometrial cancer who are candidates for surgery will be included.

Primary Endpoint Self-reported quality of life questionnaire score.

Sample Size 168 patients will be randomized to detect a difference of 6 points in the questionnaires.

Estimated Dates for Completing Accrual and Presenting Results Study completion is estimated for January 2026 and the results will be presented in May 2026.

Trial Registration number NCT05918770.

  • Quality of Life (PRO)/Palliative Care
  • Surgical Oncology

Data availability statement

All data relevant to the study are included in the article.

Statistics from Altmetric.com

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

Data availability statement

All data relevant to the study are included in the article.

View Full Text

Footnotes

  • Twitter @BlancaG24130028, @AinhoaMada

  • Contributors BG-I and GLG are involved in study conception and design, drafting the manuscript, protocol design, data collection, analysis and interpretation of results, and as guarantor of the study. AT-G, MRO, and AM will contribute to data collection. AB, AN, AG, MMJ, AGG, and PFR contributed to study conception, protocol design, and analysis and interpretation of results. All authors have read and agreed to the published version of the manuscript.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial, or not-for-profit sectors.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; internally peer reviewed.