NCT04070950

Brief Summary

This study aims to study in patients with cancer of the cervix or the body of the uterus, or the ovary between the time of diagnosis and 3 months after the end of the last treatment: the evolution of the relationship of couple, and more particularly of communication (verbal and non-verbal) concerning sexuality, before and during cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2009

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2010

Completed
9.3 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
Last Updated

June 10, 2026

Status Verified

August 1, 2019

Enrollment Period

9 months

First QC Date

August 23, 2019

Last Update Submit

June 8, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluation of sexual activity

    Questionnaire SAQ : Sexual Activity Questionnaire, contains 21 items divided into three parts: the first part allows to know if a woman is sexually active or not, the second part allows to define the reasons for this activity or its absence. The third part of the questionnaire filled out by sexually active women aims to explore the pleasure generated by sex (desire, satisfaction, frequency), discomfort during intercourse, especially due to vaginal dryness and pain as well as the habits of the patient before the illness.

    3 months after the end of therapeutic treatment (not the object of the study)

Study Arms (1)

Single group

Interview of patients with cancer of the cervix or uterine body, or ovary between the time of diagnosis and 3 months after the end of their last cancer treatment (not the object of the study).

Other: Questionnaires

Interventions

Two self-questionnaires

Single group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen with cancer of the cervix or uterine body, or ovarian
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women with cancer of the cervix or uterine body, or ovarian

You may qualify if:

  • Age ≥ 18 years
  • Life in a couple or single with a regular partner for at least 3 months
  • Cancer of the cervix or uterine body or ovarian cancer, in first diagnosis and treatment
  • Whatever the stage of cancer
  • Curative treatment
  • Support in one of the participating centers
  • Possible follow-up of all stages of the research

You may not qualify if:

  • Presence of metastases
  • History of other cancer
  • History of severe psychiatric illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Bordeaux, France

Location

Related Publications (1)

  • Giacomoni C, Venturini E, Hoarau H, Guyon F, Conri V. How women with gynaecological cancer deal with treatment: issues of visibility and invisibility. Gynecol Obstet Fertil. 2014 Nov;42(11):795-9. doi: 10.1016/j.gyobfe.2014.09.013. Epub 2014 Oct 19.

MeSH Terms

Conditions

Sexual BehaviorPelvic Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

BehaviorNeoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Alain RAVAUD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2019

First Posted

August 28, 2019

Study Start

September 1, 2009

Primary Completion

May 20, 2010

Study Completion

May 20, 2010

Last Updated

June 10, 2026

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations