Study on Sexual Health and Self-perceived Quality of Life (PROMs) in Patients Treated for Cervical Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sex hormones and modulators of the genital system..
- Who it may be relevant to
- Registry conditions: Cervical Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Randomized Study on Sexual Health and Self-perceived Quality of Life (PROMs) in Patients Treated for Cervical Cancer
Overview
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.
Detailed description
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.
Interventions
- Drug 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.
Primary outcome measures
- 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. [Time frame: Month 12(V5).]
Secondary outcome measures (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. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: Through study completion, an average of one year]
- To evaluate adherence to the proposed multimodal treatment and the adverse effects reported. [Time frame: 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. [Time frame: Throught study completion, an average of one year]
- To evaluate adherence to the proposed multimodal treatment and the adverse effects reported. [Time frame: At Baseline level(V2), at month 6 (V4), and month 12 (V5)]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Laura Burunat — Teià
Identifiers
NCT: NCT07412873 · 2025-521460-36-00