Clinical trial NCT06031493: A Multimodal Intervention Program to Improve Sexual Health and Self-perceived Quality of Life in Patients Treated for Cervical Cancer (PROVIDENCE)
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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Cervical Cancer
Sexual Dysfunction
Quality of Life
Keywords: cervical cancer
sexual dysfunction
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Hospital Universitario 12 de Octubre
First posted: 2023-09-11
Enrollment: 122
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, multi-institutional, national, randomized clinical trial with two parallel arms.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: FSFI score
timeFrame: 12 months after completion of primary treatment for cervical cancer
Secondary outcomes:
measure: FSFI (6 months)
timeFrame: 6 months after completion of primary treatment for cervical cancer
measure: EORTC QLQ-30
timeFrame: 12 months after completion of primary treatment for cervical cancer
measure: EORTC QLQ-30 (6 months)
timeFrame: 6 months after completion of primary treatment for cervical cancer
measure: EORTC Cx-24 (6 months)
timeFrame: 6 months after completion of primary treatment for cervical cancer
measure: EORTC Cx-24
timeFrame: 12 months after completion of primary treatment for cervical cancer
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
Study officials:
affiliation: Hospital Universitario 12 de Octubre
name: Blanca Gil-Ibáñez, MD, PhD
role: STUDY_DIRECTOR
affiliation: Hospital Clinic of Barcelona
name: Berta Díaz-Feijoo, MD, PhD
role: STUDY_DIRECTOR
References: