Identification of the Most Suitable Questionnaire to Assess the Sexual Function of Women Living in France After Colorectal Cancer Surgery (EVAS-CCR)

University of Limoges (UL)

Status: Enrolling

Conditions: Colorectal Cancer

Treatments: Other: administration of the 4 quality of sexual life questionnaires

Study type: Interventional

Funder types: Other

Identifiers

NCT05391321

87RI21_0062

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 1 patient group

administration of quality of sexual life questionnaires

Experimental group

Treatment:

Other: administration of the 4 quality of sexual life questionnaires