Prospective Randomized Study on Sexual Health and Self-perceived Quality of Life (PROMs) in Patients Treated for Cervical Cancer
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To evaluate the improvement in sexual function and self-perceived quality of life using Patient-Reported Outcomes in patients treated for cervical cancer who undergo a multimodal intervention in the sexual sphere and lifestyle.
研究概览
简要总结
To assess the improvement in sexual function and self-perceived quality of life using PROMs (Patient-Reported Outcomes) in patients treated for cervical cancer who undergo a multimodal intervention in the sexual sphere and lifestyle compared to those who undergo care within routine clinical practice.
详细描述
Prospective, randomized 2:1 study in favor of the intervention group, multicenter, superiority, to be performed in patients treated for cervical cancer divided into 2 study groups: 1) intervention group that will undergo a multimodal intervention in the sexual sphere and lifestyle; and 2) control group according to routine clinical practice.
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 of legal age.
- •Patients with primary cervical cancer stage FIGO I-III (initial or locally advanced) of squamous histology, adenocarcinoma or adenosquamous.
- •Patients treated for cancer with surgery and/or radiotherapy ± systemic treatment in the Gynaecological Oncology Units of hospitals in Spain.
- •Complete response after oncospecific treatment was obtained.
- •Signature of the informed consent (IC) by the patient or responsible family member.
排除标准
- •Patients under 18 years of age.
- •Pregnancy or breastfeeding.
- •Partial response after completion of oncospecific treatment.
- •Patients with premalignant pathology.
- •Diagnosis of a tumor of non-cervical origin or atypical histologies.
- •Impossibility of completing the questionnaires included in the protocol autonomously.
- •Contraindications to the use of vaginal estrogens.
- •Patients undergoing fertility-sparing treatment (trachelectomy or conization).
- •Patients undergoing palliative treatment.
研究组 & 干预措施
Intervention Arm
Group that will undergo a multinodal intervention in the sexual sphere and lifestyle
干预措施: Sex hormones and modulators of the genital system. (Drug)
Control Arm
Control group according to routine clinical practice
结局指标
主要结局
To evaluate the improvement in sexual function and self-perceived quality of life using Patient-Reported Outcomes in patients treated for cervical cancer who undergo a multimodal intervention in the sexual sphere and lifestyle.
时间窗: Month 12(V5).
Global score on the Female Sexual Function Index (FSFI) form at the end of the first year after treatment. The values go from zero to five, or from 1 to 5. A higher score mean a better outcome.
次要结局
- To evaluate sexual function (using the Female Sexual Function Index (FSFI) questionnaire) in women treated for cervical cancer after completion of treatment and its evolution over one year.(Baseline level(V2), 3 months after treatment(V3), at 6 month(V4) and 12 months after treatment(V5).)
- To evaluate self-perceived quality of life questionnaires in women treated for cervical cancer after completing treatment and its evolution over one year.(At diagnosis(V1), after treatment(V2), at month 6(V4), and month 12(V5) after the treatment)
- To detect the needs of the treated patients based on the Patient-Reported Outcome Measures(PROMs) questionnaires, that allow proposing improvement strategies that can increase their sexual health and quality of life.(Month 12(V5))
- To evaluate vaginal trophism more objectively using the Vaginal Health Index (VHI) in women with cervical cancer after completion of treatment and over the course of one year.(Through study completion, an average of one year)
- To evaluate adherence to the proposed multimodal treatment and the adverse effects reported.(At Baseline level(V2), at month 6(V4) and month 12(V5))
- To evaluate vaginal trophism more objectively using the vaginal thickness measured by ultrasound in women with cervical cancer after completion of treatment and over the course of one year.(Throught study completion, an average of one year)
- To evaluate adherence to the proposed multimodal treatment and the adverse effects reported.(At Baseline level(V2), at month 6 (V4), and month 12 (V5))