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

Institut Claudius Regaud

Status: Completed

Conditions: Vaginal Cancer; Cervix Cancer

Treatments: Other: Patients with cervix or vaginal cancer treated by radiotherapy and brachytherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03956498

19 GENF 02

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Patients with cervix or vaginal cancer

Other group

Treatment:

Other: Patients with cervix or vaginal cancer treated by radiotherapy and brachytherapy