Assessment of Patients' Quality of Sexual Life After Anal Cancer Treatment (SEQUOIA)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Anxiety; Anal Cancer; HPV; Sexuality; Psychologic Stress
• Intervention / Treatment: Other: Quality of life questionnaire

Detailed Description

Sexual health is defined by WHO in 2011 as a state of physical, emotional, mental and social well-being in relation to sexuality. It is an integral part of health, well-being and quality of life and is recognized as a right of everyone.Alteration of sexuality after cancer impacts all phases of the sexual response. It is multifactorial: psychological (ie, anxiety linked to the disease, fear of death, or impairment of body image) and physiological (ie, alteration of the sexual reaction which may be linked, in part, to direct sequelae generated by irradiation of the genitals).

Anal cancer remains fairly rare, affecting around 2,200 people each year in France, with a predominance of women (60 to 70% of patients), However, its incidence has been growing strongly for 30 years, in Europe and the United States where it is has increased by 70% over the last 10 years alone, in both men and women, with an increasingly younger population.

It is linked, in more than 90% of cases, to a carcinogenic virus, the Human PapillomaVirus (HPV), a late consequence of an infection, most often asymptomatic, transmitted by the sexual route.

The question of sexuality after cancer remains, in fact, very little addressed by doctors who express a lack of training. Patients, for their part, often do not dare to raise the issue with caregivers, out of modesty, or thinking that the teams do not have the time. Discussions with patients therefore generally always remain focused on oncological management, from the initial consultation to the follow-up consultations. The hope of recovery awaited on each of the assessments and the fear of relapse often obscure more global and equally essential questions: whether it is about the quality of life, the after-effects, or even more, the quality. of sex life. For these reasons, this study will collect the information provided to patients on the impact of this treatment on their sexual health, whether it is medical information recorded in the file, or information perceived and retained by patients.

• Study Type: Observational
• Enrollment (Actual): 46

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34090
    • Institut Regional du Cancer de Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Anal cancer patients; Non-metastatic squamous anus cancer with the presence of an HPV infection authenticated on the biopsy	Other: Quality of life questionnaire; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
• Investigators: Study Chair: Claire LEMANSKI, MD, Institut Regional du Cancer de Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2021
• Primary Completion (Actual): August 31, 2023
• Study Completion (Estimated): June 6, 2025

Study Registration Dates

• First Submitted: October 4, 2021
• First Submitted That Met QC Criteria: November 3, 2021
• First Posted (Actual): November 5, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Behavioral Symptoms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Anus Diseases; Rectal Neoplasms; Stress, Psychological; Anus Neoplasms
• Other Study ID Numbers: PROICM 2021-03 OSE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No