A Multimodal Intervention Program to Improve Sexual Health and Self-perceived Quality of Life in Patients Treated for Cervical Cancer (PROVIDENCE)
PROVIDENCE
1 other identifier
interventional
122
1 country
2
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2025
Shorter than P25 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 4, 2023
CompletedFirst Posted
Study publicly available on registry
September 11, 2023
CompletedStudy Start
First participant enrolled
January 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2025
CompletedFebruary 28, 2024
August 1, 2023
1 month
September 4, 2023
February 27, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
FSFI score
global score in FSFI (Female Sexual Function Index) questionnaire
12 months after completion of primary treatment for cervical cancer
Secondary Outcomes (5)
FSFI (6 months)
6 months after completion of primary treatment for cervical cancer
EORTC QLQ-30
12 months after completion of primary treatment for cervical cancer
EORTC QLQ-30 (6 months)
6 months after completion of primary treatment for cervical cancer
EORTC Cx-24 (6 months)
6 months after completion of primary treatment for cervical cancer
EORTC Cx-24
12 months after completion of primary treatment for cervical cancer
Study Arms (2)
Multimodal Intervention Group
EXPERIMENTALMultimodal Intervention on sexual dysfunction and quality-of-life after treatment for cervical cancer: application of topical vaginal estrogens, systematic evaluation of the need of systemic hormone replacement therapy (and treatment if needed), application of hormone-free vaginal-vulvar moisturizing cream containing hyaluronic acid, use of a vaginal vibrator twice a week for 5 to 10 minutes each time with the help of intimate lubricant, access to online informational content about sexuality, access to online informational content about nutrition, access to online informational content about sports, access to online informational content about lifestyle habits
Standard Care Group
NO INTERVENTIONStandard follow-up in Gynecological Oncology Units of participating centers after treatment for cervical cancer
Interventions
Multimodal intervention includes education on healthy habits, the prevention of vaginal dysfunction using vaginal moisturizers and topical estrogens, and a systematic evaluation of the need of hormone replacement therapy.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital Clinic of Barcelonalead
- Hospital Universitario 12 de Octubrecollaborator
Study Sites (2)
Hospital Clínic de Barcelona
Barcelona, 08036, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Related Publications (1)
Gil-Ibanez B, Carreras-Dieguez N, Lopez G, Sanchez-Hoyo B, Nuno BC, Oliver-Perez R, Castelo-Branco C, Marina T, Torne A, Tejerizo A, Diaz-Feijoo B. 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). J Gynecol Oncol. 2025 Jul;36(4):e56. doi: 10.3802/jgo.2025.36.e56. Epub 2025 Jan 29.
PMID: 39924671DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Blanca Gil-Ibáñez, MD, PhD
Hospital Universitario 12 de Octubre
- STUDY DIRECTOR
Berta Díaz-Feijoo, MD, PhD
Hospital Clinic of Barcelona
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2023
First Posted
September 11, 2023
Study Start
January 1, 2025
Primary Completion
February 1, 2025
Study Completion
April 1, 2025
Last Updated
February 28, 2024
Record last verified: 2023-08