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

NCT07412873 | Not Yet Recruiting Phase 4

• 1 other identifier: 2025-521460-36-00
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  Month 12(V5).

Secondary Outcomes (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.

  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)

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Group that will undergo a multinodal intervention in the sexual sphere and lifestyle

Drug: Sex hormones and modulators of the genital system.

Control Arm

NO INTERVENTION

Control group according to routine clinical practice

Interventions

Sex hormones and modulators of the genital system. DRUG

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.

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion Clinic per a la Recerca Biomédica: lead

Study Sites (1)

Laura Burunat

Teià, Barcelona, 08329, Spain

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Gonadal Steroid Hormones

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Laura B Burunat, Graduate

CONTACT

+342275400; burunat@recerca.clinic.cat

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: February 17, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

ES (1)