Clinical trial · Interventional
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Quality of Life | — | UNRESOLVED | — |
| Sexual Dysfunction | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multimodal intervention on sexual dysfunction and quality-of-life | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Multimodal Intervention Group
- description
- Multimodal 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
- interventionNames
- Combination Product: Multimodal intervention on sexual dysfunction and quality-of-life
- type
- NO_INTERVENTION
- label
- Standard Care Group
- description
- Standard follow-up in Gynecological Oncology Units of participating centers after treatment for cervical cancer
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDGil-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 39924671