Cervical CancerPhase 4PROVIDENCENCT06031493
A Multimodal Intervention Program to Improve Sexual Health and Self-perceived Quality of Life in Patients Treated for Cervical Cancer (PROVIDENCE)
A Phase 4 study testing Multimodal intervention on sexual dysfunction and quality-of-life in people with Cervical Cancer and Sexual Dysfunction, run by Hospital Clinic of Barcelona at 2 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer, Sexual Dysfunction, Quality of Life
- What is being tested?
- Multimodal intervention on sexual dysfunction and quality-of-life
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 2 sitesSpain
- Study dates
- Jan 2025to Apr 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Blanca Gil-Ibáñez, MD, PhD contact
Spain2 sites
Hospital Clínic de Barcelona
Barcelona, 08036
Núria Carreras, MD PhD, ncarreras@clinic.cat
Hospital Universitario 12 de Octubre
Madrid, 28041
About this study
Official title: 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)
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.
Read the detailed description
Cervical cancer treatment, both radical hysterectomy and chemoradiotherapy, can impair all scopes of daily life and, beyond the physical changes caused by treatment, has psychological and social implications that influence health-related quality of life (HR-QoL). Patients undergoing treatment for cervical cancer have shown to score less in HR-QoL scales compared to healthy women. More than half of women with gynecological cancer experience sexual dysfunction, especially those affected by cervical cancer. In spite of the latest 2023 ESGO/ESTRO/ESP recommendations on the management of cervical cancer, several observational studies indicate that the percentage of cervical cancer patients receiving information and treatment for early menopause and sexual dysfunction, especially regarding hormone replacement therapy, does not exceed 50%.
The PROVIDENCE trial is a multi-institutional, national, randomized clinical trial which aims to demonstrate that a multimodal intervention including patient education on sexuality and healthy habits and the prevention of vaginal dysfunction reduces sexual disfunction and HR-QoL impairment in patients treated for cervical cancer. The recruitment period is scheduled from January 2024 to December 2026 and will be held in Gynecology Oncology Units of referral hospitals in Spain.
Patients will be randomized 1:1 at diagnosis of cervical cancer to control arm or intervention arm. After treatment for initial or locally advanced cervical cancer, patients in the control arm will undergo the standard follow-up and treatment of post-treatment morbidity will be performed following the standard procedures as determined by their referring physician. The proposed multimodal intervention for patients assigned to the intervention group (detailed below) includes education on healthy habits, the prevention of vaginal dysfunction using vaginal moisturizers and topical estrogens, and a systematic evaluation of the need of hormone replacement therapy.
- Conditions
- Cervical Cancer, Sexual Dysfunction, Quality of Life
- Being tested
- Multimodal intervention on sexual dysfunction and quality-of-life
- Keywords
- cervical cancer, sexual dysfunction
- Medical subject headings
- Uterine Cervical Neoplasms, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal intervention on sexual dysfunction and quality-of-lifeCombination product
Multimodal intervention includes education on healthy habits, the prevention of vaginal dysfunction using vaginal moisturizers and topical estrogens, and a systematic evaluation of the need of hormone replacement therapy.
| Study group | Role | What they receive |
|---|---|---|
| Multimodal Intervention Group | Experimental | 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 Receives: Combination Product: Multimodal intervention on sexual dysfunction and quality-of-life |
| Standard Care Group | No intervention | Standard follow-up in Gynecological Oncology Units of participating centers after treatment for cervical cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
FSFI score
global score in FSFI (Female Sexual Function Index) questionnaire
Measured: 12 months after completion of primary treatment for cervical cancer
Secondary outcomes (5)
FSFI (6 months)
global score in FSFI (Female Sexual Function Index) questionnaire
Measured: 6 months after completion of primary treatment for cervical cancer
EORTC QLQ-30
global score in EORTC (European Organisation for Research and Treatment of Cancer) QLQ-30 questionnaire
Measured: 12 months after completion of primary treatment for cervical cancer
EORTC QLQ-30 (6 months)
global score in EORTC QLQ-30 questionnaire
Measured: 6 months after completion of primary treatment for cervical cancer
EORTC Cx-24 (6 months)
global score in EORTC Cx-24 questionnaire
Measured: 6 months after completion of primary treatment for cervical cancer
EORTC Cx-24
global score in EORTC Cx-24 questionnaire
Measured: 12 months after completion of primary treatment for cervical cancer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study startJan 2025 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- 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
- Model description
- prospective, multi-institutional, national, randomized clinical trial with two parallel arms.
- Masking
- None (open label)
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario 12 de Octubre
- Responsible party
- Sponsor
- Investigators
- Blanca Gil-Ibáñez, MD, PhD, Study director, Hospital Universitario 12 de OctubreBerta Díaz-Feijoo, MD, PhD, Study director, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06031493
- Sponsor's protocol ID
- PROVIDENCE
- Acronym
- PROVIDENCE
- Status last verified
- Aug 2023
- First submitted
- 4 Sep 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gil-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.
PubMed 39924671
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06031493
- Acronym / sponsor ID
- PROVIDENCE / PROVIDENCE
- Conditions
- Cervical Cancer, Sexual Dysfunction, Quality of Life
- Keywords
- cervical cancer, sexual dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Hospital Universitario 12 de Octubre
- Study start
- Jan 2025 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 11 Sep 2023 (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.
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.
Detailed description
Cervical cancer treatment, both radical hysterectomy and chemoradiotherapy, can impair all scopes of daily life and, beyond the physical changes caused by treatment, has psychological and social implications that influence health-related quality of life (HR-QoL). Patients undergoing treatment for cervical cancer have shown to score less in HR-QoL scales compared to healthy women. More than half of women with gynecological cancer experience sexual dysfunction, especially those affected by cervical cancer. In spite of the latest 2023 ESGO/ESTRO/ESP recommendations on the management of cervical cancer, several observational studies indicate that the percentage of cervical cancer patients receiving information and treatment for early menopause and sexual dysfunction, especially regarding hormone replacement therapy, does not exceed 50%.
The PROVIDENCE trial is a multi-institutional, national, randomized clinical trial which aims to demonstrate that a multimodal intervention including patient education on sexuality and healthy habits and the prevention of vaginal dysfunction reduces sexual disfunction and HR-QoL impairment in patients treated for cervical cancer. The recruitment period is scheduled from January 2024 to December 2026 and will be held in Gynecology Oncology Units of referral hospitals in Spain.
Patients will be randomized 1:1 at diagnosis of cervical cancer to control arm or intervention arm. After treatment for initial or locally advanced cervical cancer, patients in the control arm will undergo the standard follow-up and treatment of post-treatment morbidity will be performed following the standard procedures as determined by their referring physician. The proposed multimodal intervention for patients assigned to the intervention group (detailed below) includes education on healthy habits, the prevention of vaginal dysfunction using vaginal moisturizers and topical estrogens, and a systematic evaluation of the need of hormone replacement therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective, multi-institutional, national, randomized clinical trial with two parallel arms.
| Arm | Type | Receives |
|---|---|---|
| Multimodal Intervention Group | Experimental | Combination Product: Multimodal intervention on sexual dysfunction and quality-of-lifeMultimodal 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 |
| Standard Care Group | No intervention | –Standard follow-up in Gynecological Oncology Units of participating centers after treatment for cervical cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Multimodal intervention on sexual dysfunction and quality-of-lifeMultimodal intervention includes education on healthy habits, the prevention of vaginal dysfunction using vaginal moisturizers and topical estrogens, and a systematic evaluation of the need of hormone replacement therapy. | Combination product | Multimodal Intervention Group |
Primary outcome
FSFI score
Time frame: 12 months after completion of primary treatment for cervical cancer
global score in FSFI (Female Sexual Function Index) questionnaire
5 secondary outcomes
FSFI (6 months)
Time frame: 6 months after completion of primary treatment for cervical cancer
EORTC QLQ-30
Time frame: 12 months after completion of primary treatment for cervical cancer
EORTC QLQ-30 (6 months)
Time frame: 6 months after completion of primary treatment for cervical cancer
EORTC Cx-24 (6 months)
Time frame: 6 months after completion of primary treatment for cervical cancer
EORTC Cx-24
Time frame: 12 months after completion of primary treatment for cervical cancer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Derived from this study: PubMed 39924671Gil-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.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Blanca Gil-Ibáñez, MD, PhD contact
Blanca Gil-Ibáñez, MD, PhD study director
Hospital Universitario 12 de Octubre
Berta Díaz-Feijoo, MD, PhD study director
Hospital Clinic of Barcelona
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Multimodal intervention on sexual dysfunction and quality-of-life in people with Cervical Cancer and Sexual Dysfunction, run by Hospital Clinic of Barcelona at 2 sites 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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Berta Díaz-Feijoo, MD, PhD (932 27 54 00, bdiazfe@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FSFI score (time frame: 12 months after completion of primary treatment for cervical cancer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06031493, which also lists 1 linked publication.
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 28 Feb 2024.