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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cervical Cancer
• Intervention / Treatment: Drug: Sex hormones and modulators of the genital system.

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Laura B Burunat, Graduate; Phone Number: 4198 +342275400; Email: burunat@recerca.clinic.cat

Study Locations

• Spain
  • Barcelona
    • Teià, Barcelona, Spain, 08329
      • Laura Burunat
      • Contact: Laura B Burunat, Chemistry; Phone Number: 4198 0034932275400; Email: burunat@recerca.clinic.cat
      • Principal Investigator: Berta D Diaz, MDPhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm; Group that will undergo a multinodal intervention in the sexual sphere and lifestyle	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.
No Intervention: Control Arm; Control group according to routine clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Score on the Female Sexual Function Index (FSFI) form at diagnosis, after treatment (defined as baseline level: 1 month after surgery and 3 months after treatment with radiotherapy ± systemic treatment), at 6 and 12 months after treatment. The score in each of the sexual response domains that make up the FSFI (subjective desire and stimulus, lubrication, orgasm, satisfaction, and pain or discomfort) will also be evaluated individually. The Female Sexual Function Index values go from zero to 5 or from 1 to 5. The higher scores the better outcome.	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.	Score on the quality of life forms at diagnosis, at baseline level(after treatment), at 6 months and 12 months after baseline level(after treatment). The score on each of the 5 functional scales (physical functioning, daily activities, emotional functioning, cognitive functioning and social functioning), 3 symptom scales (fatigue, pain and nausea, vomiting), the global health status scale and the 6 independent items (dyspnea, insomnia, anorexia, constipation, diarrhoea and economic impact) that make up the European Organisation for Research and treatment of Cancer(EORTC QLQ-30) will also be assessed individually. The first 28 questions got values which go from 1 to 4 and the lower score the better outcome. The other two last ones have values go from 1 to 7 and the higher scores the better outcome.	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.	Adherence to multimodal treatment in the intervention arm, defined as the percentage of patients in the intervention arm who have undergone each of the items included in the multimodal treatment. The items included in the multimodal treatment are the use of moisturizing creams vaginal and vulvar without hormones and topical vaginal estrogens with their dosage, the use of the personal massager staff, and access to the informative content about life habits.	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.	Number of adverse effects related with the use of treatments, assessing their number, severity and type (A - Augmented; B - Bizarre)	Through study completion, an average of one year
To evaluate adherence to the proposed multimodal treatment and the adverse effects reported.	Vaginal Health Index (VHI) score for assessment of vaginal trophism at diagnosis, baseline level(after treatment), at 6 and 12 months after baseline level.	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.	Number of adverse events related to the use of treatments, assessing their number, severity and type(A-Augmented; B-Bizarre)	Throught study completion, an average of one year
To evaluate adherence to the proposed multimodal treatment and the adverse effects reported.	Thickness measured by ultrasound for assessment of vaginal trophism at diagnosis, baseline level(after treatment), at 6 and 12 months after baseline level.	At Baseline level(V2), at month 6 (V4), and month 12 (V5)

Collaborators and Investigators

• Sponsor: Fundacion Clinic per a la Recerca Biomédica

Study record dates

Study Major Dates

• Study Start (Estimated): March 2, 2026
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): June 30, 2029

Study Registration Dates

• First Submitted: September 30, 2025
• First Submitted That Met QC Criteria: February 9, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Uterine Cervical Neoplasms; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Gonadal Hormones; Gonadal Steroid Hormones
• Other Study ID Numbers: 2025-521460-36-00

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No