Impact of a Sexological Follow-up on the Sexual Function in Patients With Cervix or Vaginal Cancer Treated by Radiotherapy and Brachytherapy
NCT ID: NCT03956498
Last Updated: 2022-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2019-10-09
2022-02-20
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Patients with cervix or vaginal cancer
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
FEMALE
No
Sponsors
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Institut Claudius Regaud
OTHER
Responsible Party
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Locations
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Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse, , France
Countries
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Other Identifiers
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19 GENF 02
Identifier Type: -
Identifier Source: org_study_id
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