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

Sponsor
University Hospital, Limoges (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05391321
Collaborator
(none)
50
Enrollment
1
Arm
18
Anticipated Duration (Months)

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Other: administration of the 4 quality of sexual life questionnaires
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
women will have to answer the 4 sexual quality of life questionnaires. the order of the 4 questionnaires will be randomizedwomen 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.
Primary Purpose:
Other
Official Title:
Identification of the Most Suitable Questionnaire to Assess the Sexual Function of Women Living in France After Colorectal Cancer Surgery
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: administration of quality of sexual life questionnaires

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

Outcome Measures

Primary Outcome Measures

  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 [6 months]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Hospital, Limoges

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT05391321
Other Study ID Numbers:
  • 87RI21_0062
First Posted:
May 25, 2022
Last Update Posted:
Jun 3, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Colorectal Neoplasms

Study Results

No Results Posted as of Jun 3, 2022