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

NCT ID: NCT05391321

Last Updated: 2023-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-12

Study Completion Date

2025-05-31

Brief Summary

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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

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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

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Colorectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

women will have to answer the 4 sexual quality of life questionnaires. the order of the 4 questionnaires will be randomized
Primary Study Purpose

OTHER

Blinding Strategy

NONE

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.

Study Groups

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administration of quality of sexual life questionnaires

Group Type EXPERIMENTAL

administration of the 4 quality of sexual life questionnaires

Intervention Type OTHER

administration of the 4 quality of sexual life questionnaires

Interventions

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administration of the 4 quality of sexual life questionnaires

administration of the 4 quality of sexual life questionnaires

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Limoges

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Limoges University Hospital

Limoges, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Muriel MATHONNET, MD

Role: CONTACT

Phone: +33 55 05 67 01

Email: [email protected]

Facility Contacts

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Muriel Mathonnet, MD

Role: primary

Other Identifiers

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87RI21_0062

Identifier Type: -

Identifier Source: org_study_id