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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)

Primary Purpose

Cervix Cancer, Vaginal Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Patients with cervix or vaginal cancer treated by radiotherapy and brachytherapy
Sponsored by
Institut Claudius Regaud
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cervix Cancer focused on measuring Cervix Cancer, Vaginal Cancer, Sexual function, Brachytherapy, Radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Institut Universitaire du Cancer de Toulouse - Oncopole

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients with cervix or vaginal cancer

Arm Description

Outcomes

Primary Outcome Measures

Female Sexual Function Index score (evolution between inclusion and 1 year after brachytherapy) assessed using FSFI (Female Sexual Function Index) Questionnaire

Secondary Outcome Measures

Quality of life assessed using QLQ-C30 questionnaire (Quality of Life Questionnaire-Core 30)
Quality of life specific for cervix cancer assessed using QLQ-CX24 questionnaire (Quality-of-Life questionnaire cervical cancer module)
Vaginal symptoms assessed using NCI-CTCAE version 5 (National Cancer Institute Common Toxicity Criteria for Adverse Events)

Full Information

First Posted
May 16, 2019
Last Updated
March 23, 2022
Sponsor
Institut Claudius Regaud
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1. Study Identification

Unique Protocol Identification Number
NCT03956498
Brief Title
Impact of a Sexological Follow-up on the Sexual Function in Patients With Cervix or Vaginal Cancer Treated by Radiotherapy and Brachytherapy
Acronym
FEMINICOL
Official Title
Impact of a Sexological Follow-up on the Sexual Function in Patients With Cervix or Vaginal Cancer Treated by Radiotherapy and Brachytherapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
October 9, 2019 (Actual)
Primary Completion Date
February 20, 2022 (Actual)
Study Completion Date
February 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Claudius Regaud

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervix Cancer, Vaginal Cancer
Keywords
Cervix Cancer, Vaginal Cancer, Sexual function, Brachytherapy, Radiotherapy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with cervix or vaginal cancer
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Patients with cervix or vaginal cancer treated by radiotherapy and brachytherapy
Intervention Description
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 Measure Information:
Title
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 Measure Information:
Title
Quality of life assessed using QLQ-C30 questionnaire (Quality of Life Questionnaire-Core 30)
Time Frame
12 months for each patient
Title
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
Title
Vaginal symptoms assessed using NCI-CTCAE version 5 (National Cancer Institute Common Toxicity Criteria for Adverse Events)
Time Frame
12 months for each patient

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years or older Woman diagnosed with cervix or vaginal cancer, for whom a treatment by radiotherapy and brachytherapy has been decided Patient receiving for the first time an utero-vaginal or vaginal brachytherapy at "Institut Universitaire du Cancer de Toulouse - Oncopole" Easter Cooperative Oncology Group (ECOG) Performance Status ≤ 2 All patients are eligible, regardless of their relationship status (in couple or not), their sexual orientation, and their hormonal status Patient willing to give informed consent before the study and before performing any study-related procedures Patient affiliated to a Social Health Insurance in France Exclusion Criteria: Patient not understanding the French language Patient for whom surgical treatment and brachytherapy has been decided Any psychological, familial, sociological or geographical condition that potentially hampers compliance with the study protocol and follow-up after treatment discontinuation schedule Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice
Facility Information:
Facility Name
Institut Universitaire du Cancer de Toulouse - Oncopole
City
Toulouse
Country
France

12. IPD Sharing Statement

Learn more about this trial

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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