Sexual BehaviorFECAPSENCT04070950
Sexuality of Women With Pelvic Cancer
An observational study of Sexual Behavior and Pelvic Cancer, run by University Hospital, Bordeaux at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Sexual Behavior, Pelvic Cancer
- What is being tested?
- Questionnaires
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2009to 20 May 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with cancer of the cervix or uterine body, or ovarian
Who may be able to join
- 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
Who cannot join
- Presence of metastases
- History of other cancer
- History of severe psychiatric illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Sexual Behavior, Pelvic Cancer
- Being tested
- Questionnaires
- Medical subject headings
- Sexual Behavior, Pelvic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Two self-questionnaires
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after the end of therapeutic treatment (not the object of the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 Sep 2009
- Primary completion20 May 2010
- Study completion20 May 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sexual BehaviorStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alain RAVAUD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04070950
- Sponsor's protocol ID
- CHUBX 2008/39
- Acronym
- FECAPSE
- Status last verified
- Aug 2019
- First submitted
- 23 Aug 2019
- Last updated
- 10 Jun 2026
- Results posted
- No
- Individual data sharing
- No
Publications
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.
PubMed 25444701
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Study of the Couple Relationship of Women With Pelvic Cancer: Impact on Sexuality
- ClinicalTrials.gov ID
- NCT04070950
- Acronym / sponsor ID
- FECAPSE / CHUBX 2008/39
- Conditions
- Sexual Behavior, Pelvic Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 1 Sep 2009 (actual)
- Primary completion
- 20 May 2010 (actual)
- Study completion
- 20 May 2010 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group | – | Other: QuestionnairesInterview 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with cancer of the cervix or uterine body, or ovarian
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- Presence of metastases
- History of other cancer
- History of severe psychiatric illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesTwo self-questionnaires | Other | Single group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Results publication: PubMed 25444701Giacomoni 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alain RAVAUD principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sexual Behavior and Pelvic Cancer, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of sexual activity (time frame: 3 months after the end of therapeutic treatment (not the object of the study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04070950, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.