A Multimodal Intervention Program to Improve Sexual Health and Self-perceived Quality of Life in Patients Treated for Cervical Cancer (PROVIDENCE)

A multimodal intervention program to improve sexual health and self-perceived quality of life in patients treated for cervical cancer: a randomized prospective study (PROVIDENCE trial)

Patients with cervical cancer treatment experience an impairment of sexual function and quality of life. This issue is usually underreported and undertreated, and evidence-based interventions are lacking. Prevention of sexual dysfunction is a crucial pillar in improving the quality of life of these patients. The primary objective of this trial is to evaluate the impact of a multimodal intervention, encompassing prevention of vaginal dysfunction and patient education, on sexual function and quality of life in cervical cancer survivors utilizing patient-reported outcome measurements. Multi-institutional, randomized clinical trial where patients will be randomized 1:2 at diagnosis of initial or locally advanced cervical cancer to control arm or intervention arm. After treatment, control arm patients will undergo standard follow-up by their referring physician. The multimodal intervention for patients in the intervention group includes application of vaginal estrogens plus hyaluronic-acid cream along with use of vaginal vibrator, systematic evaluation of the need of systemic hormone replacement therapy and treatment if needed, and access to online content about sexuality, nutrition, sports and lifestyle habits. Through 4 appointments (at diagnosis, 1, 6, and 12 months after treatment), sexual health, vaginal trophism and self-perceived quality of life of patients in both arms will be assessed with validated questionnaires as female sexual function index (FSFI), European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30, and Cx-24, Cervantes Scale, vaginal health index and vaginal thickness assessed by ultrasound. The major inclusion criteria will be patients aged ≥18 years with the International Federation of Gynecology and Obstetrics stage I-III cervical cancer treated with surgery and/or radiotherapy. The primary endpoint will be FSFI score 12 months after treatment, which will be compared between groups. Uni- and multivariate analysis will be performed to identify factors influencing sexual function recovery after treatment. The sample size will be of 120 eligible patients, who will be randomized to detect an improvement of 5.2 points in FSFI score. Complete accrual is estimated in March 2026. To date, the present study has no external funding. ClinicalTrials.gov Identifier: NCT06031493.

Alvaro Tejerizo

Aureli Torné

Beatrice Conti Nuño

Beatriz Sánchez-Hoyo

Berta Díaz-Feijoo

Blanca Gil-Ibañez

Dr. Blanca Gil Ibañez is a medical doctor specializing in Gynecology and Obstetrics and a clinical researcher subspecialized in Gynecologic Oncology. She was the first Spanish gynecologic oncologist to obtain European accreditation from the European Society of Gynaecological Oncology (ESGO). She has completed training fellowships at Charité Hospital (Humboldt University, Berlin) and the Herbert Irving Comprehensive Cancer Center (Columbia University, New York). She holds a Master’s degree in Gynecologic Endoscopy from the University of Barcelona, where she currently serves as a faculty member. Since 2021, she has co-coordinated the Spanish National Research Network in Gynecologic Oncology (Spain-GOG) and has led the 2025 update of the Spanish national guidelines on cervical cancer (SEGO). She is a member of GEICO (Spanish Group for Research in Gynecologic Cancer), where she acts as Coordinator of the Surgical Committee and Member of the Quality of Life Working Group, promoting research lines focused on surgical innovation and the well-being of gynecologic oncology patients. Her research activity focuses on fertility preservation in early-stage cervical cancer (CEFER study) and on the quality of life of gynecologic oncology patients. She is the principal investigator of the multicenter HALIS study (screening of sequelae through telemedicine-based PROMs, funded by La Marató de TV3) and of the PROVIDENCE trial (a prospective randomized study on sexual health and quality of life after cervical cancer treatment, funded by the Instituto de Salud Carlos III – AES 2024). She is an active member of the ESGO Accreditation Committee for Training Centers and the ESGO Education Committee, where she leads the Working Group on Subspecialty Training and Curriculum Development. She is also part of the International Network on Cancer, Infertility and Pregnancy (INCIP), coordinating the ABCIP Advisory Board for Spain and Central America. Dr. Gil Ibañez supervises PhD theses at the Universities of Barcelona and Complutense of Madrid and participates in national and international clinical trials. She has published as first and last author in high-impact (Q1) scientific journals and received the 2023 Young Investigator Award in Oncology from the AstraZeneca–ISCIII Foundation. She currently carries out her clinical and research activity at the Gynecologic Oncology Unit of Hospital Universitario 12 de Octubre (Madrid), an ESGO-accredited training center for subspecialists, where she also leads teaching activities, surgical courses, and resident training. In 2025, she was invited by the Spanish Agency for International Development Cooperation (AECID) as an international speaker at the Global Forum on Cervical Cancer Elimination.

Camil Castelo-Branco

Gregorio López

Núria Carreras

Oliver Pérez María de los Reyes

Tiermes Marina Martin