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

Quality of Life Clinical Trial

— 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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06031493
• Other study ID #: PROVIDENCE
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: January 2025
• Est. completion date: April 2025

Study information

• Verified date: August 2023
• Source: Hospital Clinic of Barcelona
• Contact: Berta Díaz-Feijoo, MD, PhD
• Phone: 932 27 54 00
• Email: bdiazfe[@]clinic.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 122
• Est. completion date: April 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Quality of Life
• Sexual Dysfunction
• Uterine Cervical Neoplasms

Intervention

Combination Product:
• Multimodal intervention on sexual dysfunction and quality-of-life
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.

Locations

Country	Name	City	State
Spain	Hospital Clínic de Barcelona	Barcelona
Spain	Hospital Universitario 12 de Octubre	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona	Hospital Universitario 12 de Octubre

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FSFI score	global score in FSFI (Female Sexual Function Index) questionnaire	12 months after completion of primary treatment for cervical cancer
Secondary	FSFI (6 months)	global score in FSFI (Female Sexual Function Index) questionnaire	6 months after completion of primary treatment for cervical cancer
Secondary	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
Secondary	EORTC QLQ-30 (6 months)	global score in EORTC QLQ-30 questionnaire	6 months after completion of primary treatment for cervical cancer
Secondary	EORTC Cx-24 (6 months)	global score in EORTC Cx-24 questionnaire	6 months after completion of primary treatment for cervical cancer
Secondary	EORTC Cx-24	global score in EORTC Cx-24 questionnaire	12 months after completion of primary treatment for cervical cancer