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

February 27, 2024 updated by: Hospital Clinic of Barcelona

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

122

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Barcelona, Spain, 08036
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multimodal Intervention Group
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
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.
No Intervention: Standard Care Group
Standard follow-up in Gynecological Oncology Units of participating centers after treatment for cervical cancer

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Collaborators

Hospital Universitario 12 de Octubre

Investigators

  • Study Director: Blanca Gil-Ibáñez, MD, PhD, Hospital Universitario 12 de Octubre
  • Study Director: Berta Díaz-Feijoo, MD, PhD, Hospital Clinic of Barcelona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

September 4, 2023

First Submitted That Met QC Criteria

September 4, 2023

First Posted (Actual)

September 11, 2023

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROVIDENCE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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