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

Primary Purpose

Colorectal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
administration of the 4 quality of sexual life questionnaires
Sponsored by
University Hospital, Limoges
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Limoges University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

administration of quality of sexual life questionnaires

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 20, 2022
Last Updated
June 9, 2023
Sponsor
University Hospital, Limoges
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1. Study Identification

Unique Protocol Identification Number
NCT05391321
Brief Title
Identification of the Most Suitable Questionnaire to Assess the Sexual Function of Women Living in France After Colorectal Cancer Surgery
Acronym
EVAS-CCR
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 12, 2023 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
women will have to answer the 4 sexual quality of life questionnaires. the order of the 4 questionnaires will be randomized
Masking
None (Open Label)
Masking Description
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.
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
administration of quality of sexual life questionnaires
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
administration of the 4 quality of sexual life questionnaires
Intervention Description
administration of the 4 quality of sexual life questionnaires
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
6 months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Muriel MATHONNET, MD
Phone
+33 55 05 67 01
Email
mathonnet@unilim.fr
Facility Information:
Facility Name
Limoges University Hospital
City
Limoges
ZIP/Postal Code
87042
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muriel Mathonnet, MD
Email
muriel.mathonnet@unilim.fr
First Name & Middle Initial & Last Name & Degree
Muriel Mathonnet, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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