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

Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle (Other)
Overall Status
Recruiting
CT.gov ID
NCT05109468
Collaborator
(none)
50
1
48
1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Assessment of Patients' Quality of Sexual Life After Anal Cancer Treatment
Actual Study Start Date :
Jun 6, 2021
Anticipated Primary Completion Date :
Jun 6, 2023
Anticipated Study Completion Date :
Jun 6, 2025

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Change in Sexual quality of life score [at inclusion, 3 months post-treatment and 2 years after the announcement of cancer.]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institut régional du Cancer de Montpellier Montpellier France 34090

Sponsors and Collaborators

  • Institut du Cancer de Montpellier - Val d'Aurelle

Investigators

  • Study Chair: Claire LEMANSKI, MD, Institut RĂ©gional du Cancer de Montpellier

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Institut du Cancer de Montpellier - Val d'Aurelle
ClinicalTrials.gov Identifier:
NCT05109468
Other Study ID Numbers:
  • PROICM 2021-03 OSE
First Posted:
Nov 5, 2021
Last Update Posted:
Nov 5, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 5, 2021