A Multimodal Intervention Program to Improve Sexual Health and Self-perceived Quality of Life in Patients Treated for Cervical Cancer: a Randomized Prospective Study (PROVIDENCE Trial)
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 122
- 试验地点
- 4
- 主要终点
- FSFI score
研究概览
简要总结
The PROVIDENCE Trial aims to explore the improvement of sexual health and self-perceived health related quality of life (measured by Patient Reported Outcome Measures) through a multimodal intervention that includes patient education on healthy habits and the prevention of vaginal dysfunction using vaginal moisturizers and topical estrogens. To achieve this, a randomized design is proposed to assess sexual health and quality of life in patients treated for cervical cancer who undergo this intervention compared to those who receive standard care.
详细描述
Cervical cancer treatment, both radical hysterectomy and chemoradiotherapy, can impair all scopes of daily life and, beyond the physical changes caused by treatment, has psychological and social implications that influence health-related quality of life (HR-QoL). Patients undergoing treatment for cervical cancer have shown to score less in HR-QoL scales compared to healthy women. More than half of women with gynecological cancer experience sexual dysfunction, especially those affected by cervical cancer. In spite of the latest 2023 ESGO/ESTRO/ESP recommendations on the management of cervical cancer, several observational studies indicate that the percentage of cervical cancer patients receiving information and treatment for early menopause and sexual dysfunction, especially regarding hormone replacement therapy, does not exceed 50%.
The PROVIDENCE trial is a multi-institutional, national, randomized clinical trial which aims to demonstrate that a multimodal intervention including patient education on sexuality and healthy habits and the prevention of vaginal dysfunction reduces sexual disfunction and HR-QoL impairment in patients treated for cervical cancer. The recruitment period is scheduled from January 2024 to December 2026 and will be held in Gynecology Oncology Units of referral hospitals in Spain.
Patients will be randomized 1:1 at diagnosis of cervical cancer to control arm or intervention arm. After treatment for initial or locally advanced cervical cancer, patients in the control arm will undergo the standard follow-up and treatment of post-treatment morbidity will be performed following the standard procedures as determined by their referring physician. The proposed multimodal intervention for patients assigned to the intervention group (detailed below) includes education on healthy habits, the prevention of vaginal dysfunction using vaginal moisturizers and topical estrogens, and a systematic evaluation of the need of hormone replacement therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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 older that 18 years, with initial or locally advanced primary cervical cancer
- •Squamous, adenocarcinoma or adenosquamous histology
- •Stage I-III cervical cancer treated with surgery and/or radiotherapy ± systemic treatment in - Gynecology Oncology Units of referral hospitals in Spain
- •Signed informed consent by the patient or legal guardian
排除标准
- •Women younger tan 18 years
- •Pregnancy or breastfeeding
- •Patients with intraepithelial lesions of cervix uteri without invasive disease
- •Metastatic tumor in the cervix uteri or primary tumor with atypical histology
- •Inability to complete the questionnaires included in the study protocol
- •Contraindications for the use of topical vaginal estrogens
- •Patients undergoing fertility-preservation treatment (conization or trachelectomy)
- •Patients undergoing palliative treatment
结局指标
主要结局
FSFI score
时间窗: 12 months after completion of primary treatment for cervical cancer
global score in FSFI (Female Sexual Function Index) questionnaire
次要结局
- EORTC QLQ-30(12 months after completion of primary treatment for cervical cancer)
- FSFI (6 months)(6 months after completion of primary treatment for cervical cancer)
- EORTC QLQ-30 (6 months)(6 months after completion of primary treatment for cervical cancer)
- EORTC Cx-24(12 months after completion of primary treatment for cervical cancer)
- EORTC Cx-24 (6 months)(6 months after completion of primary treatment for cervical cancer)