Cervical CancerPhase 4PROVIDENCENCT07412873
Study on Sexual Health and Self-perceived Quality of Life (PROMs) in Patients Treated for Cervical Cancer
A Phase 4 study testing Sex hormones and modulators of the genital system. in people with Cervical Cancer, run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Sex hormones and modulators of the genital system.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 2 Mar 2026to 30 Jun 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Contraindications to the use of vaginal estrogens.
- Patients undergoing fertility-sparing treatment (trachelectomy or conization).
- Patients undergoing palliative treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Laura Burunat
Teià, Barcelona, 08329
Laura B Burunat, Chemistry, 0034932275400 ext. 4198, burunat@recerca.clinic.cat
Berta D Diaz, MDPhD
About this study
Official title: Prospective Randomized Study on Sexual Health and Self-perceived Quality of Life (PROMs) in Patients Treated for Cervical Cancer
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.
Read the detailed description
Prospective, randomized 2:1 study in favor of the intervention group, multicenter, superiority, to be performed in patients treated for cervical cancer divided into 2 study groups: 1) intervention group that will undergo a multimodal intervention in the sexual sphere and lifestyle; and 2) control group according to routine clinical practice.
- Conditions
- Cervical Cancer
- Being tested
- Sex hormones and modulators of the genital system.
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sex hormones and modulators of the genital system.Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Group that will undergo a multinodal intervention in the sexual sphere and lifestyle Receives: Drug: Sex hormones and modulators of the genital system. |
| Control Arm | No intervention | Control group according to routine clinical practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Global score on the Female Sexual Function Index (FSFI) form at the end of the first year after treatment. The values go from zero to five, or from 1 to 5. A higher score mean a better outcome.
Measured: Month 12(V5).
Secondary outcomes (7)
To evaluate sexual function (using the Female Sexual Function Index (FSFI) questionnaire) in women treated for cervical cancer after completion of treatment and its evolution over one year.
Score on the Female Sexual Function Index (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. The Female Sexual Function Index values go from zero to 5 or from 1 to 5. The higher scores the better outcome.
Measured: Baseline level(V2), 3 months after treatment(V3), at 6 month(V4) and 12 months after treatment(V5).
To evaluate self-perceived quality of life questionnaires in women treated for cervical cancer after completing treatment and its evolution over one year.
Score on the quality of life forms at diagnosis, at baseline level(after treatment), at 6 months and 12 months after baseline level(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 (dyspnea, insomnia, anorexia, constipation, diarrhoea and economic impact) that make up the European Organisation for Research and treatment of Cancer(EORTC QLQ-30) will also be assessed individually. The first 28 questions got values which go from 1 to 4 and the lower score the better outcome. The other two last ones have values go from 1 to 7 and the higher scores the better outcome.
Measured: At diagnosis(V1), after treatment(V2), at month 6(V4), and month 12(V5) after the treatment
To detect the needs of the treated patients based on the Patient-Reported Outcome Measures(PROMs) questionnaires, that allow proposing improvement strategies that can increase their sexual health and quality of life.
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. The items included in the multimodal treatment are the use of moisturizing creams vaginal and vulvar without hormones and topical vaginal estrogens with their dosage, the use of the personal massager staff, and access to the informative content about life habits.
Measured: Month 12(V5)
To evaluate vaginal trophism more objectively using the Vaginal Health Index (VHI) in women with cervical cancer after completion of treatment and over the course of one year.
Number of adverse effects related with the use of treatments, assessing their number, severity and type (A - Augmented; B - Bizarre)
Measured: Through study completion, an average of one year
To evaluate adherence to the proposed multimodal treatment and the adverse effects reported.
Vaginal Health Index (VHI) score for assessment of vaginal trophism at diagnosis, baseline level(after treatment), at 6 and 12 months after baseline level.
Measured: At Baseline level(V2), at month 6(V4) and month 12(V5)
To evaluate vaginal trophism more objectively using the vaginal thickness measured by ultrasound in women with cervical cancer after completion of treatment and over the course of one year.
Number of adverse events related to the use of treatments, assessing their number, severity and type(A-Augmented; B-Bizarre)
Measured: Throught study completion, an average of one year
To evaluate adherence to the proposed multimodal treatment and the adverse effects reported.
Thickness measured by ultrasound for assessment of vaginal trophism at diagnosis, baseline level(after treatment), at 6 and 12 months after baseline level.
Measured: At Baseline level(V2), at month 6 (V4), and month 12 (V5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start2 Mar 2026 (estimated)
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Clinic per a la Recerca Biomédica
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07412873
- Sponsor's protocol ID
- 2025-521460-36-00
- Other IDs
- 2025
- Acronym
- PROVIDENCE
- Status last verified
- Feb 2026
- First submitted
- 30 Sep 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study on Sexual Health and Self-perceived Quality of Life (PROMs) in Patients Treated for Cervical Cancer
- ClinicalTrials.gov ID
- NCT07412873
- Acronym / sponsor ID
- PROVIDENCE / 2025-521460-36-00
- Conditions
- Cervical Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fundacion Clinic per a la Recerca BiomédicaUniversity, hospital or other
- Study start
- 2 Mar 2026 (estimated)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Prospective, randomized 2:1 study in favor of the intervention group, multicenter, superiority, to be performed in patients treated for cervical cancer divided into 2 study groups: 1) intervention group that will undergo a multimodal intervention in the sexual sphere and lifestyle; and 2) control group according to routine clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Drug: Sex hormones and modulators of the genital system.Group that will undergo a multinodal intervention in the sexual sphere and lifestyle |
| Control Arm | No intervention | –Control group according to routine clinical practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sex hormones and modulators of the genital system.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. | Drug | Intervention Arm |
Primary outcome
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.
Time frame: Month 12(V5).
Global score on the Female Sexual Function Index (FSFI) form at the end of the first year after treatment. The values go from zero to five, or from 1 to 5. A higher score mean a better outcome.
7 secondary outcomes
To evaluate sexual function (using the Female Sexual Function Index (FSFI) questionnaire) in women treated for cervical cancer after completion of treatment and its evolution over one year.
Time frame: Baseline level(V2), 3 months after treatment(V3), at 6 month(V4) and 12 months after treatment(V5).
To evaluate self-perceived quality of life questionnaires in women treated for cervical cancer after completing treatment and its evolution over one year.
Time frame: At diagnosis(V1), after treatment(V2), at month 6(V4), and month 12(V5) after the treatment
To detect the needs of the treated patients based on the Patient-Reported Outcome Measures(PROMs) questionnaires, that allow proposing improvement strategies that can increase their sexual health and quality of life.
Time frame: Month 12(V5)
To evaluate vaginal trophism more objectively using the Vaginal Health Index (VHI) in women with cervical cancer after completion of treatment and over the course of one year.
Time frame: Through study completion, an average of one year
To evaluate adherence to the proposed multimodal treatment and the adverse effects reported.
Time frame: At Baseline level(V2), at month 6(V4) and month 12(V5)
To evaluate vaginal trophism more objectively using the vaginal thickness measured by ultrasound in women with cervical cancer after completion of treatment and over the course of one year.
Time frame: Throught study completion, an average of one year
To evaluate adherence to the proposed multimodal treatment and the adverse effects reported.
Time frame: At Baseline level(V2), at month 6 (V4), and month 12 (V5)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sex hormones and modulators of the genital system. in people with Cervical Cancer, run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura B Burunat, Graduate (+342275400 ext. 4198, burunat@recerca.clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Month 12(V5).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.