Clinical trial · Interventional
Impact of a Sexological Follow-up on the Sexual Function in Patients With Cervix or Vaginal Cancer Treated by Radiotherapy and Brachytherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervix Cancer | — | UNRESOLVED | — |
| Vaginal Cancer | Malignant Vaginal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Patients with cervix or vaginal cancer treated by radiotherapy and brachytherapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Patients with cervix or vaginal cancer
- interventionNames
- Other: Patients with cervix or vaginal cancer treated by radiotherapy and brachytherapy
Primary outcomes (1)
- measure
- Female Sexual Function Index score (evolution between inclusion and 1 year after brachytherapy) assessed using FSFI (Female Sexual Function Index) Questionnaire
- timeFrame
- 12 months for each patient
Secondary outcomes (3)
- measure
- Quality of life assessed using QLQ-C30 questionnaire (Quality of Life Questionnaire-Core 30)
- timeFrame
- 12 months for each patient
- measure
- Quality of life specific for cervix cancer assessed using QLQ-CX24 questionnaire (Quality-of-Life questionnaire cervical cancer module)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available