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

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Vaginal cancer
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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

September 2021

Primary Completion Date

September 2021

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

, ,

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

January 2021