Clinical trial NCT05391321: Identification of the Most Suitable Questionnaire to Assess the Sexual Function of Women Living in France After Colorectal Cancer Surgery
Official title: Identification of the Most Suitable Questionnaire to Assess the Sexual Function of Women Living in France After Colorectal Cancer Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2022-05-25
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: women will have to answer the 4 sexual quality of life questionnaires. the order of the 4 questionnaires will be randomized
Primary purpose: OTHER

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
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
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Limoges
country: France
facility: Limoges University Hospital
Study officials:
References: