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Prospective randomized study on sexual health and self-perceived quality of life (PROMs) in patients treated for cervical cancer

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-521460-36-00
Acronym
Providence
Enrollment
120
Registered
2025-05-09
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical cancer

Brief summary

Global score on the FSFI (Female Sexual Function Index) form at the end of the first year after treatment.

Detailed description

Score on the FSFI form at diagnosis, after treatment (defined as baseline level: 1 month after surgery and 3 months after treatment with radiotherapy ± systemic treatment), at 6 and 12 months after treatment. The score in each of the sexual response domains that make up the FSFI (subjective desire and stimulus, lubrication, orgasm, satisfaction, and pain or discomfort) will also be evaluated individually., Score on the quality of life forms (EORTC QLQ-30, Cx-24, Cervantes- Reduced) at diagnosis, after treatment (baseline level), at 6 months and 12 months after treatment. The score on each of the 5 functional scales (physical functioning, daily activities, emotional functioning, cognitive functioning and social functioning), 3 symptom scales (fatigue, pain and nausea, vomiting), the global health status scale and the 6 independent items of EORTC QLQ-30, Adherence to multimodal treatment in the intervention arm, defined as the percentage of patients in the intervention arm who have undergone each of the items included in the multimodal treatment., Adverse effects with the use of treatments, assessing their number, severity and type (A - Augmented; B - Bizarre), Vaginal Health Index (VHI) score and thickness measured by ultrasound, for assessment of vaginal trophism at diagnosis, after treatment (baseline level), at 6 and 12 months after treatment.

Interventions

DRUGESTRADIOL HEMIHYDRATE
DRUGPROGESTERONE
DRUGESTRADIOL VALERATE

Sponsors

Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Global score on the FSFI (Female Sexual Function Index) form at the end of the first year after treatment.

Secondary

MeasureTime frame
Score on the FSFI form at diagnosis, after treatment (defined as baseline level: 1 month after surgery and 3 months after treatment with radiotherapy ± systemic treatment), at 6 and 12 months after treatment. The score in each of the sexual response domains that make up the FSFI (subjective desire and stimulus, lubrication, orgasm, satisfaction, and pain or discomfort) will also be evaluated individually., Score on the quality of life forms (EORTC QLQ-30, Cx-24, Cervantes- Reduced) at diagnosis, after treatment (baseline level), at 6 months and 12 months after treatment. The score on each of the 5 functional scales (physical functioning, daily activities, emotional functioning, cognitive functioning and social functioning), 3 symptom scales (fatigue, pain and nausea, vomiting), the global health status scale and the 6 independent items of EORTC QLQ-30, Adherence to multimodal treatment in the intervention arm, defined as the percentage of patients in the intervention arm who have under

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026