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NCT Number: NCT07412873

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Laura Burunat

Teià, Barcelona, 08329, Spain

Location contact

Berta D Diaz, MDPhD

PRINCIPAL_INVESTIGATOR

Laura B Burunat, Chemistry

CONTACT

[email protected]

0034932275400 ext. 4198

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

    Time frame: Month 12(V5).

    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.

Secondary outcomes

  1. 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).

    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.

  2. 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

    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.

  3. 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)

    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.

  4. 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

    Number of adverse effects related with the use of treatments, assessing their number, severity and type (A - Augmented; B - Bizarre)

  5. 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)

    Vaginal Health Index (VHI) score for assessment of vaginal trophism at diagnosis, baseline level(after treatment), at 6 and 12 months after baseline level.

  6. 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

    Number of adverse events related to the use of treatments, assessing their number, severity and type(A-Augmented; B-Bizarre)

  7. 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)

    Thickness measured by ultrasound for assessment of vaginal trophism at diagnosis, baseline level(after treatment), at 6 and 12 months after baseline level.

Study contacts

Contact information is provided by the study sponsor or research team.

Laura B Burunat, Graduate

CONTACT

[email protected]

+342275400 ext. 4198

Sponsors and collaborators

Lead sponsor

Fundacion Clinic per a la Recerca Biomédica

Other

Registry information

Official study title

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

Acronym: PROVIDENCE

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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