Study on Sexual Health and Self-perceived Quality of Life (PROMs) in Patients Treated for Cervical Cancer

Официальное название

Prospective Randomized Study on Sexual Health and Self-perceived Quality of Life (PROMs) in Patients Treated for Cervical Cancer

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Sex hormones and modulators of the genital system.
  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.

Первичные конечные точки

• 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. [Срок оценки: Month 12(V5).]

Вторичные конечные точки (7)

• 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: Through study completion, an average of one year]
• To evaluate adherence to the proposed multimodal treatment and the adverse effects reported. [Срок оценки: 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. [Срок оценки: Throught study completion, an average of one year]
• To evaluate adherence to the proposed multimodal treatment and the adverse effects reported. [Срок оценки: At Baseline level(V2), at month 6 (V4), and month 12 (V5)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Laura Burunat — Teià

Идентификаторы

NCT: NCT07412873 · 2025-521460-36-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗