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

• Sponsor: Institut Claudius Regaud (Other)
• Overall Status: Completed
• CT.gov ID: NCT03956498
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arm: 1
• Actual Duration (Months): 28.4
• Patients Per Site Per Month: 2.1

Study Details

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	N/A

Study Design

• Study Type: Interventional
• 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: Oct 9, 2019
• Actual Primary Completion Date: Feb 20, 2022
• Actual Study Completion Date: Feb 20, 2022

Arms and Interventions

Arm

Intervention/Treatment

Other: 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 [12 months for each patient]

Secondary Outcome Measures

1. Quality of life assessed using QLQ-C30 questionnaire (Quality of Life Questionnaire-Core 30) [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) [12 months for each patient]

3. Vaginal symptoms assessed using NCI-CTCAE version 5 (National Cancer Institute Common Toxicity Criteria for Adverse Events) [12 months for each patient]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	Institut Universitaire du Cancer de Toulouse - Oncopole	Toulouse		France

Sponsors and Collaborators

• Institut Claudius Regaud

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Institut Claudius Regaud
• ClinicalTrials.gov Identifier: NCT03956498
• Other Study ID Numbers: 19 GENF 02
• First Posted: May 20, 2019
• Last Update Posted: Mar 24, 2022
• Last Verified: Mar 1, 2022

• 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: Vaginal Neoplasms; Uterine Cervical Neoplasms

Study Results

No Results Posted as of Mar 24, 2022