Clinical trial · Interventional
Study on Sexual Health and Self-perceived Quality of Life (PROMs) in Patients Treated for Cervical Cancer
Prospective Randomized Study on Sexual Health and Self-perceived Quality of Life (PROMs) in Patients Treated for Cervical Cancer
NCT07412873CI-TRIAL-00103392PROVIDENCEnot yet recruitingPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- 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)
To assess the improvement in sexual function and self-perceived quality of life using PROMs (Patient-Reported Outcomes) in patients treated for cervical cancer who undergo a multimodal intervention in the sexual sphere and lifestyle compared to those who undergo care within routine clinical practice.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sex hormones and modulators of the genital system. | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention Arm
- description
- Group that will undergo a multinodal intervention in the sexual sphere and lifestyle
- interventionNames
- Drug: Sex hormones and modulators of the genital system.
- type
- NO_INTERVENTION
- label
- Control Arm
- description
- Control group according to routine clinical practice
Primary outcomes (1)
- measure
- To evaluate the improvement in sexual function and self-perceived quality of life using Patient-Reported Outcomes in patients treated for cervical cancer who undergo a multimodal intervention in the sexual sphere and lifestyle.
- timeFrame
- Month 12(V5).
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women of legal age. * Patients with primary cervical cancer stage FIGO I-III (initial or locally advanced) of squamous histology, adenocarcinoma or adenosquamous. * Patients treated for cancer with surgery and/or radiotherapy ± systemic treatment in the Gynaecological Oncology Units of hospitals in Spain. * Complete response after oncospecific treatment was obtained. * Signature of the informed consent (IC) by the patient or responsible family member. Exclusion Criteria: * Patients under 18 years of age. * Pregnancy or breastfeeding. * Partial response after completion of oncospecific treatment. * Patients with premalignant pathology. * Diagnosis of a tumor of non-cervical origin or atypical histologies. * Impossibility of completing the questionnaires included in the protocol autonomously. * Contraindications to the use of vaginal estrogens. * Patients undergoing fertility-sparing treatment (trachelectomy or conization). * Patients undergoing palliative treatment.
References
Publications (0)
Data not yet available
No reference posted for this study.