Colorectal CancerEVAS-CCRNCT05391321
Identification of the Most Suitable Questionnaire to Assess the Sexual Function of Women Living in France After Colorectal Cancer Surgery
A study testing administration of the 4 quality of sexual life questionnaires in people with Colorectal Cancer, run by University Hospital, Limoges at 1 site in France.
Trial summary
Sexual quality of life is rarely mentioned by physicians during follow-up consultations, even though it is the source of a significant deterioration in quality of life (QOL). The assessment of female sexual function is based on self-administered questionnaires. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- administration of the 4 quality of sexual life questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- 12 May 2023to 7 Jan 2025
- Phase
- Interventional
- 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
Who may be able to join
- female
- over 18 years of age
- who have signed the informed consent to participate in the study
- having had rectal or recto-sigmoid cancer at least one year before, whatever the stage, treated by rectal or recto-sigmoid resection with sphincter preservation
- in the course of an eventual adjuvant treatment (chemotherapy or radiotherapy)
- affiliated to the social security system of the health insurance, whatever the system
Who cannot join
- colon cancer
- pelvic radiotherapy for a pathology other than colorectal cancer
- rectal resection without restoration of continuity (Hartmann or abdominal-perineal amputation)
- peritoneal carcinosis
- colorectal resection for benign lesion
- Inflammatory bowel disease (IBD)
- emergency surgery
Trial locations and contacts
1 site in 1 country.
About this study
Sexual quality of life is rarely mentioned by physicians during follow-up consultations, even though it is the source of a significant deterioration in quality of life (QOL).
The assessment of female sexual function is based on self-administered questionnaires. Four questionnaires have been translated and validated in French: FSFI, PISQ-IR, PISQ-12, BISF.
The objective of this project is to determine which questionnaire is acceptable and adapted to a cohort of women living in France who have undergone treatment for rectal cancer
Read the detailed description
Quality of life (QoL) is often impaired in the aftermath of rectal cancer management due to impaired rectal function and the impact of surgery and radiation therapy on pelvic innervation and the genitourinary sphere. Female sexual function is rarely mentioned by caregivers during follow-up consultations, even though it is a source of significant alteration in the quality of life. Assessment of sexual function is based on self-assessment questionnaires. Most of them were written in English and correspond to the Anglo-Saxon culture. Four questionnaires were translated and validated in French: FSFI, PISQ-IR, PISQ-12, BISF. Two are general sexual HRQOL questionnaires, 2 are sexual HRQOL questionnaires developed for women with genitourinary prolapse.
The identification of the acceptable questionnaire adapted to women living in France will be done through a randomized double-blind study. The duration of patient participation will be 6 months, corresponding to the period of inclusion, collection of informed consent, sending of the questionnaire bundles and collection of the bundles.
- Conditions
- Colorectal Cancer
- Being tested
- administration of the 4 quality of sexual life questionnaires
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
administration of the 4 quality of sexual life questionnairesOther
administration of the 4 quality of sexual life questionnaires
| Study group | Role | What they receive |
|---|---|---|
| administration of quality of sexual life questionnaires | Experimental | Not described Receives: Other: administration of the 4 quality of sexual life questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preference ranking of 4 validated sexual QOL questionnaires in French, FSFI, PISQ-IR, PISQ-12, BISF assessed on the collection of questionnaire returns by patients
Preference ranking of 4 validated sexual QOL questionnaires in French, FSFI, PISQ-IR, PISQ-12, BISF assessed on the collection of questionnaire returns by patients
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start12 May 2023
- Primary completion20 May 2024
- Study completion7 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- women will have to answer the 4 sexual quality of life questionnaires. the order of the 4 questionnaires will be randomized
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05391321
- Sponsor's protocol ID
- 87RI21_0062
- Acronym
- EVAS-CCR
- Status last verified
- Aug 2026
- First submitted
- 20 May 2022
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of the Most Suitable Questionnaire to Assess the Sexual Function of Women Living in France After Colorectal Cancer Surgery
- ClinicalTrials.gov ID
- NCT05391321
- Acronym / sponsor ID
- EVAS-CCR / 87RI21_0062
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 12 May 2023 (actual)
- Primary completion
- 20 May 2024 (actual)
- Study completion
- 7 Jan 2025 (actual)
- First posted
- 25 May 2022 (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.
Sexual quality of life is rarely mentioned by physicians during follow-up consultations, even though it is the source of a significant deterioration in quality of life (QOL).
The assessment of female sexual function is based on self-administered questionnaires. Four questionnaires have been translated and validated in French: FSFI, PISQ-IR, PISQ-12, BISF.
The objective of this project is to determine which questionnaire is acceptable and adapted to a cohort of women living in France who have undergone treatment for rectal cancer
Detailed description
Quality of life (QoL) is often impaired in the aftermath of rectal cancer management due to impaired rectal function and the impact of surgery and radiation therapy on pelvic innervation and the genitourinary sphere. Female sexual function is rarely mentioned by caregivers during follow-up consultations, even though it is a source of significant alteration in the quality of life. Assessment of sexual function is based on self-assessment questionnaires. Most of them were written in English and correspond to the Anglo-Saxon culture. Four questionnaires were translated and validated in French: FSFI, PISQ-IR, PISQ-12, BISF. Two are general sexual HRQOL questionnaires, 2 are sexual HRQOL questionnaires developed for women with genitourinary prolapse.
The identification of the acceptable questionnaire adapted to women living in France will be done through a randomized double-blind study. The duration of patient participation will be 6 months, corresponding to the period of inclusion, collection of informed consent, sending of the questionnaire bundles and collection of the bundles.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- women will have to answer the 4 sexual quality of life questionnaires. the order of the 4 questionnaires will be randomized
| Arm | Type | Receives |
|---|---|---|
| administration of quality of sexual life questionnaires | Experimental | Other: administration of the 4 quality of sexual life questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- female
- over 18 years of age
- who have signed the informed consent to participate in the study
- having had rectal or recto-sigmoid cancer at least one year before, whatever the stage, treated by rectal or recto-sigmoid resection with sphincter preservation
- in the course of an eventual adjuvant treatment (chemotherapy or radiotherapy)
Key exclusion criteria (7 listed)
- colon cancer
- pelvic radiotherapy for a pathology other than colorectal cancer
- rectal resection without restoration of continuity (Hartmann or abdominal-perineal amputation)
- peritoneal carcinosis
- colorectal resection for benign lesion
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 |
|---|---|---|
| administration of the 4 quality of sexual life questionnairesadministration of the 4 quality of sexual life questionnaires | Other | administration of quality of sexual life questionnaires |
Primary outcome
Preference ranking of 4 validated sexual QOL questionnaires in French, FSFI, PISQ-IR, PISQ-12, BISF assessed on the collection of questionnaire returns by patients
Time frame: 6 months
Preference ranking of 4 validated sexual QOL questionnaires in French, FSFI, PISQ-IR, PISQ-12, BISF assessed on the collection of questionnaire returns by patients
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 31 Aug 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing administration of the 4 quality of sexual life questionnaires in people with Colorectal Cancer, run by University Hospital, Limoges 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 6 inclusion and 7 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 31 Aug 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?
Preference ranking of 4 validated sexual QOL questionnaires in French, FSFI, PISQ-IR, PISQ-12, BISF assessed on the collection of questionnaire returns by patients (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Aug 2026.