UnknownPhase 4

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

Spain122 participantsStarted 2025-01

Plain-language summary

The PROVIDENCE Trial aims to explore the improvement of sexual health and self-perceived health related quality of life (measured by Patient Reported Outcome Measures) through a multimodal intervention that includes patient education on healthy habits and the prevention of vaginal dysfunction using vaginal moisturizers and topical estrogens. To achieve this, a randomized design is proposed to assess sexual health and quality of life in patients treated for cervical cancer who undergo this intervention compared to those who receive standard care.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Women older that 18 years, with initial or locally advanced primary cervical cancer * Squamous, adenocarcinoma or adenosquamous histology * Stage I-III cervical cancer treated with surgery and/or radiotherapy ± systemic treatment in - Gynecology Oncology Units of referral hospitals in Spain * Signed informed consent by the patient or legal guardian Exclusion Criteria: * Women younger tan 18 years * Pregnancy or breastfeeding * Patients with intraepithelial lesions of cervix uteri without invasive disease * Metastatic tumor in the cervix uteri or primary tumor with atypical histology * Inability to complete the questionnaires included in the study protocol * Contraindications for the use of topical vaginal estrogens * Patients undergoing fertility-preservation treatment (conization or trachelectomy) * Patients undergoing palliative treatment

What they're measuring

FSFI score

Timeframe: 12 months after completion of primary treatment for cervical cancer

Trial details

NCT IDNCT06031493

SponsorHospital Clinic of Barcelona

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02

Contact for this trial

Berta Díaz-Feijoo, MD, PhD

932 27 54 00 bdiazfe@clinic.cat