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

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

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.


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

Study Design
Layout table for study information
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
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021
Arms and Interventions
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.
Outcome Measures
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 ]

Eligibility Criteria
Layout table for eligibility information
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
Contacts and Locations

Locations
Layout table for location information
France
Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse, France
Sponsors and Collaborators
Institut Claudius Regaud
Tracking Information
First Submitted Date  ICMJE May 16, 2019
First Posted Date  ICMJE May 20, 2019
Last Update Posted Date January 6, 2021
Actual Study Start Date  ICMJE October 9, 2019
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2019) 		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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 16, 2019) 		Female Sexual Function Index score (evolution between inclusion and 1 year after brachytherapy) [ Time Frame: 12 months for each patient ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2019)
  • Quality of life assessed using QLQ-C30 questionnaire (Quality of Life Questionnaire-Core 30) [ Time Frame: 12 months for each patient ]
  • 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 ]
  • Vaginal symptoms assessed using NCI-CTCAE version 5 (National Cancer Institute Common Toxicity Criteria for Adverse Events) [ Time Frame: 12 months for each patient ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2019)
  • Quality of life assessed using Quality of Life Questionnaire-Core 30 (QLQ-C30) [ Time Frame: 12 months for each patient ]
  • Quality of life specific for cervix cancer assessed using Quality-of-Life questionnaire cervical cancer module QLQ-CX24 [ Time Frame: 12 months for each patient ]
  • Vaginal symptoms assessed using National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 5 [ Time Frame: 12 months for each patient ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of a Sexological Follow-up on the Sexual Function in Patients With Cervix or Vaginal Cancer Treated by Radiotherapy and Brachytherapy
Official Title  ICMJE 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Cervix Cancer
  • Vaginal Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE Patients with cervix or vaginal cancer
Intervention: Other: Patients with cervix or vaginal cancer treated by radiotherapy and brachytherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 3, 2020) 		60
Original Estimated Enrollment  ICMJE
 (submitted: May 16, 2019) 		55
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03956498
Other Study ID Numbers  ICMJE 19 GENF 02
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institut Claudius Regaud
Study Sponsor  ICMJE Institut Claudius Regaud
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Institut Claudius Regaud
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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