Assessment of Patients' Quality of Sexual Life After Anal Cancer Treatment

NCT05109468 | Active Not Recruiting

• 1 other identifier: PROICM 2021-03 OSE
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this this study, to evaluate the quality of sexual life of patients treated for anal cancer treated by radiotherapy, during their treatment, then 3 months after treatment and, finally, 2 years after treatment. cancer diagnosis.

Conditions

Anal Cancer; Sexuality; Psychologic Stress; HPV; Anxiety

Outcome Measures

Primary Outcomes (1)

• Change in Sexual quality of life score

  Sexual quality of life score obtained on the European EORTC SHQ-C22 questionnaire

  at inclusion, 3 months post-treatment and 2 years after the announcement of cancer.

Study Arms (1)

Anal cancer patients

Non-metastatic squamous anus cancer with the presence of an HPV infection authenticated on the biopsy

Other: Quality of life questionnaire

Interventions

Quality of life questionnaire OTHER

to assess the quality of sexual life of patients treated for anal cancer treated with radiotherapy, during their treatment, then 3 months after treatment and, finally, 2 years after cancer diagnosis.

Anal cancer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This project is a descriptive study without formal calculation of the number of subjects required. The sample size will be based on the ability to recruit at the ICM over a 30-month period. The active queue of patients at the ICM is about 3 to 4 patients per month, with an estimate of the proportion of refusals expected at 50% in these patients still on the shock of the announcement of cancer, where the theme of sexuality does not always appear essential at this time. Recruiting 50 patients would make it possible to have an estimate (for descriptive purposes) of the mean scores after treatment (visit 3 months after treatment) on the EORTC SHQ-C22 quality of sexual life questionnaire (the range of which goes from 0 to 100 ), with a level of precision of 12.25 (amplitude of the confidence interval) for a two-sided 95% confidence interval and a standard deviation of 22.

You may qualify if:

• Age\> 18 years old.
• Patient treated for non-metastatic squamous cell anus cancer with the presence of an HPV infection authenticated on the biopsy.
• Patient living with a partner or having an active sex life the year preceding the diagnosis.
• Patient who, after information, agrees to participate in the study.
• Patient affiliated to a French social security scheme.

You may not qualify if:

• Patient unable or unwilling to complete a questionnaire on the quality of sexual life.
• Patient without sexual activity the year before diagnosis.
• Patient whose regular follow-up is impossible for psychological, family, social or geographic reasons.
• Patient under guardianship, curatorship or legal protection.

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (1)

Institut régional du Cancer de Montpellier

Montpellier, 34090, France

Location

MeSH Terms

Conditions

Anus Neoplasms; Sexuality; Stress, Psychological; Anxiety Disorders

Condition Hierarchy (Ancestors)

Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases; Sexual Behavior; Behavior; Behavioral Symptoms; Mental Disorders

Study Officials

• Claire LEMANSKI, MD

  Institut Régional du Cancer de Montpellier

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: November 5, 2021
• Study Start: June 6, 2021
• Primary Completion: August 31, 2023
• Study Completion: June 6, 2025
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)