Sexuality of Women With Pelvic Cancer (FECAPSE)

August 26, 2019 updated by: University Hospital, Bordeaux

Longitudinal Study of the Couple Relationship of Women With Pelvic Cancer: Impact on Sexuality

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The representations associated with sexuality and cancer seem antinomic: wellbeing / death, and yet combine in the experience of cancer. The latter has an impact on sexuality in terms of satisfaction or sexual activity and on the relationship in terms of support.

In addition, various studies show the psychological impact of treatments on the couple's relationship or the body image of women with cancer. Their abilities to seduce are affected and explain the decrease of their sexual activity during the treatments: a communication, valuing the femininity, would it then facilitate the relations of couple? There is no work that considers sexuality in a systematic way (sexual act and verbal and non-verbal communication) and apprehends its link with the evolution of the relationship, from the diagnosis of cancer to the end of treatments.

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.

Study Type

Observational

Enrollment (Actual)

40

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Two self-questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of sexual activity
Time Frame: 3 months after the end of therapeutic treatment (not the object of the study)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Principal Investigator: Alain RAVAUD, University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2009

Primary Completion (Actual)

May 20, 2010

Study Completion (Actual)

May 20, 2010

Study Registration Dates

First Submitted

August 23, 2019

First Submitted That Met QC Criteria

August 26, 2019

First Posted (Actual)

August 28, 2019

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 26, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2008/39

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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