Brief Title
Impact of a Sexological Follow-up on the Sexual Function in Patients With Cervix or Vaginal Cancer Treated by Radiotherapy and Brachytherapy
Official Title
Impact of a Sexological Follow-up on the Sexual Function in Patients With Cervix or Vaginal Cancer Treated by Radiotherapy and Brachytherapy
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.
Study Type
Interventional
Primary Outcome
Female Sexual Function Index score (evolution between inclusion and 1 year after brachytherapy) assessed using FSFI (Female Sexual Function Index) Questionnaire
Secondary Outcome
Quality of life assessed using QLQ-C30 questionnaire (Quality of Life Questionnaire-Core 30)
Condition
Cervix Cancer
Intervention
Patients with cervix or vaginal cancer treated by radiotherapy and brachytherapy
Study Arms / Comparison Groups
Patients with cervix or vaginal cancer
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
60
Start Date
October 9, 2019
Completion Date
February 20, 2022
Primary Completion Date
February 20, 2022
Eligibility Criteria
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT03956498
Organization ID
19 GENF 02
Responsible Party
Sponsor
Study Sponsor
Institut Claudius Regaud
Study Sponsor
, ,
Verification Date
March 2022