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

Cervix Cancer Clinical Trial

— FEMINICOL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03956498
• Other study ID #: 19 GENF 02
• Status: Completed
• Phase: N/A
• Start date: October 9, 2019
• Est. completion date: February 20, 2022

Study information

• Verified date: March 2022
• Source: Institut Claudius Regaud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 20, 2022
• Est. primary completion date: February 20, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervix Cancer
• Uterine Cervical Neoplasms
• Vaginal Cancer
• Vaginal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
France	Institut Universitaire du Cancer de Toulouse - Oncopole	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Institut Claudius Regaud

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Female Sexual Function Index score (evolution between inclusion and 1 year after brachytherapy) assessed using FSFI (Female Sexual Function Index) Questionnaire		12 months for each patient
Secondary	Quality of life assessed using QLQ-C30 questionnaire (Quality of Life Questionnaire-Core 30)		12 months for each patient
Secondary	Quality of life specific for cervix cancer assessed using QLQ-CX24 questionnaire (Quality-of-Life questionnaire cervical cancer module)		12 months for each patient
Secondary	Vaginal symptoms assessed using NCI-CTCAE version 5 (National Cancer Institute Common Toxicity Criteria for Adverse Events)		12 months for each patient