NCT03956498

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 20, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

October 9, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2022

Completed
Last Updated

March 24, 2022

Status Verified

March 1, 2022

Enrollment Period

2.4 years

First QC Date

May 16, 2019

Last Update Submit

March 23, 2022

Conditions

Cervix CancerVaginal Cancer

Keywords

Cervix CancerVaginal CancerSexual functionBrachytherapyRadiotherapy

Outcome Measures

Primary Outcomes (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 Outcomes (3)

  • Quality of life assessed using QLQ-C30 questionnaire (Quality of Life Questionnaire-Core 30)

    12 months for each patient

  • Quality of life specific for cervix cancer assessed using QLQ-CX24 questionnaire (Quality-of-Life questionnaire cervical cancer module)

    12 months for each patient

  • Vaginal symptoms assessed using NCI-CTCAE version 5 (National Cancer Institute Common Toxicity Criteria for Adverse Events)

    12 months for each patient

Study Arms (1)

Patients with cervix or vaginal cancer

OTHER
Other: Patients with cervix or vaginal cancer treated by radiotherapy and brachytherapy

Interventions

Patients with cervix or vaginal cancer treated by radiotherapy and brachytherapyOTHER

* 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.

Patients with cervix or vaginal cancer

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Universitaire du Cancer de Toulouse - Oncopole

Toulouse, France

Location

MeSH Terms

Conditions

Uterine Cervical NeoplasmsVaginal Neoplasms

Interventions

Brachytherapy

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesVaginal Diseases

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2019

First Posted

May 20, 2019

Study Start

October 9, 2019

Primary Completion

February 20, 2022

Study Completion

February 20, 2022

Last Updated

March 24, 2022

Record last verified: 2022-03

Locations

FR(1)