A Multimodal Intervention Program to Improve Sexual Health and Self-perceived Quality of Life in … (NCT06031493) | Clinical Trial Compass
UnknownPhase 4
A Multimodal Intervention Program to Improve Sexual Health and Self-perceived Quality of Life in Patients Treated for Cervical Cancer (PROVIDENCE)
Spain122 participantsStarted 2025-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
FSFI score
Timeframe: 12 months after completion of primary treatment for cervical cancer