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

Not Applicable

Completed

• Conditions: Cervix Cancer; Vaginal Cancer
• Interventions: Other: Patients with cervix or vaginal cancer treated by radiotherapy and brachytherapy

• Registration Number: NCT03956498
• Lead Sponsor: Institut Claudius Regaud

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-16
• Study First Submitted QC: 2019-05-16
• Study First Posted: 2019-05-20
• Study Start: 2019-10-09
• Primary Completion: 2022-02-20
• Study Completion: 2022-02-20
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-23
• Last Update Posted: 2022-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with cervix or vaginal cancer	Patients with cervix or vaginal cancer treated by radiotherapy and brachytherapy	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Institut Universitaire du Cancer de Toulouse - Oncopole; 🇫🇷 Toulouse, France