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

Anxiety Clinical Trial

— SEQUOIA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05109468
• Other study ID #: PROICM 2021-03 OSE
• Status: Recruiting
• Start date: June 6, 2021
• Est. completion date: June 6, 2025

Study information

• Verified date: October 2021
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: Jean-Pierre BLEUSE, MD
• Phone: 0467613102
• Email: jean-pierre.bleuse[@]icm.unicancer.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 6, 2025
• Est. primary completion date: June 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anal Cancer
• Anus Neoplasms
• Anxiety
• HPV
• Psychologic Stress
• Sexuality
• Stress, Psychological

Intervention

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.

Locations

Country	Name	City	State
France	Institut régional du Cancer de Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.