Status:
UNKNOWN
A Multimodal Intervention Program to Improve Sexual Health and Self-perceived Quality of Life in Patients Treated for Cervical Cancer (PROVIDENCE)
Lead Sponsor:
Hospital Clinic of Barcelona
Collaborating Sponsors:
Hospital Universitario 12 de Octubre
Conditions:
Cervical Cancer
Sexual Dysfunction
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief 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 interventio...
Detailed Description
Cervical cancer treatment, both radical hysterectomy and chemoradiotherapy, can impair all scopes of daily life and, beyond the physical changes caused by treatment, has psychological and social impli...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT06031493
Start Date
January 1 2025
End Date
April 1 2025
Last Update
February 28 2024
Active Locations (2)
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1
Hospital Clínic de Barcelona
Barcelona, Spain, 08036
2
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041