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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 42
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Masking Description
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •Patient aware of her HPV status and how it is transmitted.
- •Indicated for external radiotherapy
- •Patient who has not received any oncological treatment prior to inclusion.
- •Patient who has given verbal consent.
排除标准
- •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,
- •Patients who do not speak French.
研究组 & 干预措施
SINGLE-ARM INTERVENTIONAL STUDY
Patients 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)
干预措施: Assessment of sexual quality of life (Other)
结局指标
主要结局
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.
时间窗: 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
次要结局
- 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)
- Describe the progression of psychological distress(at inclusion, at 3 months, at 6 months)