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

NCT07523152 — Not applicable, Not yet recruiting, 42 participants, Institut du Cancer de Montpellier - Val d'Aurelle

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RegistryNCT07523152, acronym SAPPHIRE
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, prevention
Enrollment42 (Estimated)
SponsorInstitut du Cancer de Montpellier - Val d'Aurelle (Other)
ConditionsPelvic Cancer, Anal Cancer, Vaginal Cancer
InterventionsAssessment of sexual quality of life (Other)
Datesstart 2026-04-02 (estimated), primary completion 2027-10-31 (estimated), completion 2027-10-31 (estimated), first posted 2026-04-13, last updated 2026-04-13

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-Summary

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.

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+Detailed description

Surgery for HPV-related pelvic cancers has a significant impact on patients' sexual quality of life.

In cervical cancer, several studies show a lasting impairment of sexual function following hysterectomy, particularly when it is radical. Long-term follow-up of patients confirms that these difficulties persist for several years after treatment and are influenced by factors such as age, hormonal status or the combination with other treatment modalities.

For vulvar and vaginal cancers, surgery frequently leads to disruptions in sexual life linked to anatomical changes and body image. A review of the literature highlights a high prevalence of dyspareunia, orgasmic disorders and reduced desire following vulvectomy, with significant psychosocial repercussions.

Finally, in anal canal cancer, abdominoperineal resection is particularly detrimental due to the anatomical and neurological sequelae it causes. Sexual quality of life is further impaired when a stoma is created, further impacting body image and self-esteem.

Reviews and studies focusing on women following cervical and other pelvic cancers show a high prevalence of sexual dysfunction (problems with desire, arousal, lubrication, pain, and reduced satisfaction).

Knowing that the cancer being treated is linked to a sexually transmitted HPV infection can lead to anxiety, guilt, relationship difficulties and a negative perception of sexuality, as highlighted in several recent studies. This immediate anxiety following the diagnosis is accompanied by impaired sexual function, particularly in cases involving genotypes 16 and 18, which carry the highest risk of cancer.

However, in the long term, cross-sectional studies report more nuanced findings.

In qualitative terms, the experience often revolves around the fear of transmitting the infection, the stigma associated with STIs and difficulties in communication within the couple, but may also foster greater openness in the relationship.

In patients with HPV-associated cancer, the physical effects of treatment, combined with the psychosexual impact linked to HPV status, can exacerbate the deterioration in sexual quality of life.

Several validated tools exist for assessing sexual quality of life following radiotherapy:

* FSFI (Female Sexual Function Index) - a multidimensional measure (desire, arousal, lubrication, orgasm, satisfaction, pain), widely used among cancer survivors.
* EORTC QLQ-SH22 (SHQ-C22) questionnaire - assesses the physical, psychological and social aspects of sexual life, also validated in oncology.
* Many studies describe changes in sexual function following radiotherapy, but few isolate the impact of HPV status or specifically assess HPV-positive patients.
* Methodological variability limits generalisability and prevents an accurate estimation of the incidence and progression of sexual dysfunction following treatment in the HPV-positive subpopulation.
* Although the consequences of radiotherapy with or without pelvic surgery on patients' sexual quality of life are better understood in clinical practice, the exact prevalence and temporal progression, as well as the specific impact of HPV status, remain insufficiently described.

+Arms and interventions

ArmTypeInterventionsDescription
SINGLE-ARM INTERVENTIONAL STUDYExperimentalOther: Assessment of sexual quality of lifePatients will be seen by the investigator at the radiotherapy clinic on enrolment, at 3 months and at 6 months (the 6-month visit will mark the end of the study)
  • Assessment of sexual quality of life (Other): The following questionnaires will be completed : EORTC QLQ-SH22 questionnaire, Questionnaire on the impact of HPV infection, HADS questionnaire

+Outcome measures

Primary outcomes

  • 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. [at baseline, 3 months and 6 months after the end of all cancer treatment]: Sexual quality of life scores obtained from the European EORTC QLQ-SH22 questionnaire

Secondary outcomes

  • To assess perceptions of, and the impact on sexuality of, the sexually transmitted nature (STI) of these cancers [at baseline, 3 months and 6 months after the end of all cancer treatment]: Questionnaire on the impact of HPV infection
  • Describe the progression of psychological distress [at inclusion, at 3 months, at 6 months]: Psychological distress scores obtained using the HADS scale, including scores for depression and anxiety.

+Eligibility

Sex: Female, ages: 18 Years to any

Inclusion Criteria:

1. Women aged 18 or over.
2. Sexually active patients, i.e. those who have been sexually active in the year prior to their cancer diagnosis.
3. Patients being treated at the Montpellier Cancer Institute (ICM).
4. Patient with pelvic squamous cell carcinoma (cervix, vagina, vulva or anus) and human papillomavirus (HPV+) infection
5. Patient aware of her HPV status and how it is transmitted.
6. Indicated for external radiotherapy
7. Patient who has not received any oncological treatment prior to inclusion.
8. Patient who has given verbal consent.

Exclusion Criteria:

1. Patients receiving radiotherapy treatment outside the Montpellier Cancer Institute (ICM).
2. Patients who are unwilling or unable to complete the study questionnaires.
3. Patients under guardianship, curatorship or court protection,
4. Patients for whom regular follow-up is impossible for psychological reasons,
5. Patients who do not speak French.

+Investigators

  • MOUSSION AURORE, Study director, DRCI ICM