Impact of a Sexological Follow-up on the Sexual Function in Patients With Cervix or Vaginal Cancer Treated by Radiotherapy and Brachytherapy (FEMINICOL)

March 23, 2022 updated by: Institut Claudius Regaud

Prospective, monocentric study evaluating the impact of a nurse-led sexological follow-up on sexual function in patients with cervix or vaginal cancer treated by radiotherapy and brachytherapy.

The study procedure will consist of nurse-led sexological consultations, beginning before brachytherapy and until 2 months after brachytherapy.

Evolution of female sexual function and vaginal symptoms will be done through clinical examinations and completion of quality of life and female sexual function questionnaires during radiation oncologist consultation and/or nurse-led sexological consultations until one year after end of brachytherapy.

Study participation of each patient will be 12 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • France
      • Toulouse, France
        • Institut Universitaire du Cancer de Toulouse - Oncopole

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. 18 years or older
  2. Woman diagnosed with cervix or vaginal cancer, for whom a treatment by radiotherapy and brachytherapy has been decided
  3. Patient receiving for the first time an utero-vaginal or vaginal brachytherapy at "Institut Universitaire du Cancer de Toulouse - Oncopole"
  4. Easter Cooperative Oncology Group (ECOG) Performance Status ≤ 2
  5. All patients are eligible, regardless of their relationship status (in couple or not), their sexual orientation, and their hormonal status
  6. Patient willing to give informed consent before the study and before performing any study-related procedures
  7. Patient affiliated to a Social Health Insurance in France

Exclusion Criteria:

  1. Patient not understanding the French language
  2. Patient for whom surgical treatment and brachytherapy has been decided
  3. Any psychological, familial, sociological or geographical condition that potentially hampers compliance with the study protocol and follow-up after treatment discontinuation schedule
  4. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice

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: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Patients with cervix or vaginal cancer
Other: Patients with cervix or vaginal cancer treated by radiotherapy and brachytherapy
  • Nurse-led sexological consultations, beginning before brachytherapy and until 2 months after brachytherapy.
  • Questionnaires to be completed by the patient before brachytherapy, 2 months after the end of brachytherapy and 1 year after the end of brachytherapy : Female Sexual Function Index (FSFI), Quality of Life Questionnaire-Core 30 (QLQ-C30), and Quality-of-Life questionnaire cervical cancer module QLQ-CX24.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Female Sexual Function Index score (evolution between inclusion and 1 year after brachytherapy) assessed using FSFI (Female Sexual Function Index) Questionnaire
Time Frame: 12 months for each patient
12 months for each patient

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life assessed using QLQ-C30 questionnaire (Quality of Life Questionnaire-Core 30)
Time Frame: 12 months for each patient
12 months for each patient
Quality of life specific for cervix cancer assessed using QLQ-CX24 questionnaire (Quality-of-Life questionnaire cervical cancer module)
Time Frame: 12 months for each patient
12 months for each patient
Vaginal symptoms assessed using NCI-CTCAE version 5 (National Cancer Institute Common Toxicity Criteria for Adverse Events)
Time Frame: 12 months for each patient
12 months for each patient

Collaborators and Investigators

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

Sponsor

Institut Claudius Regaud

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 (ACTUAL)

October 9, 2019

Primary Completion (ACTUAL)

February 20, 2022

Study Completion (ACTUAL)

February 20, 2022

Study Registration Dates

First Submitted

May 16, 2019

First Submitted That Met QC Criteria

May 16, 2019

First Posted (ACTUAL)

May 20, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 24, 2022

Last Update Submitted That Met QC Criteria

March 23, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19 GENF 02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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