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

NCT05391321 | Unknown

• 1 other identifier: 87RI21_0062
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

administration of quality of sexual life questionnaires

EXPERIMENTAL

Other: administration of the 4 quality of sexual life questionnaires

Interventions

administration of the 4 quality of sexual life questionnaires OTHER

administration of the 4 quality of sexual life questionnaires

administration of quality of sexual life questionnaires

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (1)

Limoges University Hospital

Limoges, 87042, France

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Muriel MATHONNET, MD

CONTACT

+33 55 05 67 01; mathonnet@unilim.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The order of the questionnaires tested will be randomized in each bundle according to the random method. Each bundle will receive a randomization number which will not be known to the patient or the principal investigator.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: women will have to answer the 4 sexual quality of life questionnaires. the order of the 4 questionnaires will be randomized

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: May 25, 2022
• Study Start: May 12, 2023
• Primary Completion: November 1, 2024
• Study Completion: May 1, 2025
• Last Updated: December 12, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)