NCT05391321

Identification of the Most Suitable Questionnaire to Assess the Sexual Function of Women Living in France After Colorectal Cancer Surgery

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University Hospital, Limoges · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
OTHER	administration of the 4 quality of sexual life questionnaires	administration of the 4 quality of sexual life questionnaires

Timeline

• Start date: 2023-05-12
• Primary completion: 2024-11-01
• Completion: 2025-05-01
• First posted: 2022-05-25
• Last updated: 2023-12-12

Locations

1 site across 1 country: France