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Assessment of Sexual Quality of Life Following Local Treatment (Radiotherapy With or Without Surgery) in Patients With HPV-positive Pelvic Cancer: a Descriptive Longitudinal Study

ConditionsPelvic CancerAnal CancerVaginal Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorInstitut du Cancer de Montpellier - Val d'Aurelle

About this trial

In patients with cancer associated with human papillomavirus (HPV), the physical effects of treatment, combined with the psychosexual impact linked to HPV status, can further impair the quality of sexual life.

However, few studies have examined the specific effect of HPV status (or knowledge of status) on the recovery/quality of sexuality following radiotherapy.

It is against this backdrop that we propose a prospective longitudinal study specifically dedicated to investigating the sexual quality of life of women with HPV-positive pelvic cancer.

This type of study will enable better quantification and description of sexual dysfunction occurring after treatment, and assessment of the impact of HPV carriage, with the future aim of guiding new prevention and management strategies.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women aged 18 or over.

Sexually active patients, i.e. those who have been sexually active in the year prior to their cancer diagnosis.

Patients being treated at the Montpellier Cancer Institute (ICM).

Patient with pelvic squamous cell carcinoma (cervix, vagina, vulva or anus) and human papillomavirus (HPV+) infection

Disqualifiers

Patients receiving radiotherapy treatment outside the Montpellier Cancer Institute (ICM).

Patients who are unwilling or unable to complete the study questionnaires.

Patients under guardianship, curatorship or court protection,

Patients for whom regular follow-up is impossible for psychological reasons,

Trial design

Design model

Single group

Treatments tested in this trial

  • Assessment of sexual quality of life

    Other intervention

    The following questionnaires will be completed : EORTC QLQ-SH22 questionnaire, Questionnaire on the impact of HPV infection, HADS questionnaire

Treatment groups

42 Participants
are divided into 1 treatment group
Group A: SINGLE-ARM INTERVENTIONAL STUDYExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

To describe the quality of sexual life among patients treated (radiotherapy, with or without chemotherapy, and/or surgery) as part of the management of HPV-positive pelvic cancer.

Sexual quality of life scores obtained from the European EORTC QLQ-SH22 questionnaire

Time frame
at baseline, 3 months and 6 months after the end of all cancer treatment

Secondary outcomes

1

To assess perceptions of, and the impact on sexuality of, the sexually transmitted nature (STI) of these cancers

Questionnaire on the impact of HPV infection

Time frame
at baseline, 3 months and 6 months after the end of all cancer treatment
2

Describe the progression of psychological distress

Psychological distress scores obtained using the HADS scale, including scores for depression and anxiety.

Time frame
at inclusion, at 3 months, at 6 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institut du Cancer de Montpellier - Val d'Aurelle

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: