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

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Brief Title

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

Official Title

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

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.
    

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


Primary Outcome

Change in Sexual quality of life score


Condition

Anal Cancer

Intervention

Quality of life questionnaire

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

50

Start Date

June 6, 2021

Completion Date

June 6, 2025

Primary Completion Date

June 6, 2023

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Claire LEMANSKI, MD, 0467613102, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT05109468

Organization ID

PROICM 2021-03 OSE


Responsible Party

Sponsor

Study Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle


Study Sponsor

Claire LEMANSKI, MD, Study Chair, Institut Régional du Cancer de Montpellier


Verification Date

October 2021