An observational study in Anal Cancer, Sexuality and Psychologic Stress, sponsored by Institut du Cancer de Montpellier - Val d'Aurelle. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Institut du Cancer de Montpellier - Val d'Aurelle · Observational
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.
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.
297 studies on the registry are indexed under Anus Neoplasms; 74 are open to participants now.
This study's enrollment of 46 is below the median of 144 across 75 observational studies indexed under Anus Neoplasms.
Browse Anus Neoplasms studies →Institut du Cancer de Montpellier - Val d'Aurelle is the lead sponsor of 142 studies on the registry; 47 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Change in Sexual quality of life score
Sexual quality of life score obtained on the European EORTC SHQ-C22 questionnaire
Time frame: at inclusion, 3 months post-treatment and 2 years after the announcement of cancer.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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