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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03956498
Recruitment Status : Completed
First Posted : May 20, 2019
Last Update Posted : March 24, 2022
Sponsor:
Information provided by (Responsible Party):
Institut Claudius Regaud

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.


Condition or disease Intervention/treatment Phase
Cervix Cancer Vaginal Cancer Other: Patients with cervix or vaginal cancer treated by radiotherapy and brachytherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Impact of a Sexological Follow-up on the Sexual Function in Patients With Cervix or Vaginal Cancer Treated by Radiotherapy and Brachytherapy
Actual Study Start Date : October 9, 2019
Actual Primary Completion Date : February 20, 2022
Actual Study Completion Date : February 20, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Patients with cervix or vaginal cancer Other: 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.




Primary Outcome Measures :
  1. Female Sexual Function Index score (evolution between inclusion and 1 year after brachytherapy) assessed using FSFI (Female Sexual Function Index) Questionnaire [ Time Frame: 12 months for each patient ]

Secondary Outcome Measures :
  1. Quality of life assessed using QLQ-C30 questionnaire (Quality of Life Questionnaire-Core 30) [ Time Frame: 12 months for each patient ]
  2. Quality of life specific for cervix cancer assessed using QLQ-CX24 questionnaire (Quality-of-Life questionnaire cervical cancer module) [ Time Frame: 12 months for each patient ]
  3. Vaginal symptoms assessed using NCI-CTCAE version 5 (National Cancer Institute Common Toxicity Criteria for Adverse Events) [ Time Frame: 12 months for each patient ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03956498


Locations
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France
Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse, France
Sponsors and Collaborators
Institut Claudius Regaud
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Responsible Party: Institut Claudius Regaud
ClinicalTrials.gov Identifier: NCT03956498    
Other Study ID Numbers: 19 GENF 02
First Posted: May 20, 2019    Key Record Dates
Last Update Posted: March 24, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Claudius Regaud:
Cervix Cancer
Vaginal Cancer
Sexual function
Brachytherapy
Radiotherapy
Additional relevant MeSH terms:
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Vaginal Neoplasms
Uterine Cervical Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Vaginal Diseases
Uterine Neoplasms
Uterine Cervical Diseases
Uterine Diseases