A Multimodal Intervention Program to Improve Sexual Health and Self-perceived Quality of Life in Patients Treated for Cervical Cancer (PROVIDENCE)

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Cervical Cancer, Sexual Dysfunction, Quality of Life

Intervention / Treatment
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* Combination Product: Multimodal intervention on sexual dysfunction and quality-of-life


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective, multi-institutional, national, randomized clinical trial with two parallel arms.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multimodal Intervention Group<br>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 | Combination Product: Multimodal intervention on sexual dysfunction and quality-of-life<br>* 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.<br>|
| No Intervention: Standard Care Group<br>Standard follow-up in Gynecological Oncology Units of participating centers after treatment for cervical cancer | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FSFI score | global score in FSFI (Female Sexual Function Index) questionnaire | 12 months after completion of primary treatment for cervical cancer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FSFI (6 months) | global score in FSFI (Female Sexual Function Index) questionnaire | 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 | 12 months after completion of primary treatment for cervical cancer | 
| EORTC QLQ-30 (6 months) | global score in EORTC QLQ-30 questionnaire | 6 months after completion of primary treatment for cervical cancer | 
| EORTC Cx-24 (6 months) | global score in EORTC Cx-24 questionnaire | 6 months after completion of primary treatment for cervical cancer | 
| EORTC Cx-24 | global score in EORTC Cx-24 questionnaire | 12 months after completion of primary treatment for cervical cancer | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical cancer, sexual dysfunction