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

Colorectal Cancer Clinical Trial

— EVAS-CCR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05391321
• Other study ID #: 87RI21_0062
• Status: Recruiting
• Phase: N/A
• Start date: May 12, 2023
• Est. completion date: May 2025

Study information

• Verified date: June 2023
• Source: University Hospital, Limoges
• Contact: Muriel MATHONNET, MD
• Phone: +33 55 05 67 01
• Email: mathonnet[@]unilim.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	Limoges University Hospital	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months