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

Fundacion Clinic per a la Recerca Biomédica

Status and phase

Not yet enrolling

Phase 4

Conditions

Cervical Cancer

Treatments

Drug: Sex hormones and modulators of the genital system.

Study type

Interventional

Funder types

Other

Identifiers

NCT07412873

2025-521460-36-00

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.