xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06031493</url>
    </required_header>
    <id_info>
      <org_study_id>PROVIDENCE</org_study_id>
      <nct_id>NCT06031493</nct_id>
    </id_info>
    <brief_title>A Multimodal Intervention Program to Improve Sexual Health and Self-perceived Quality of Life in Patients Treated for Cervical Cancer (PROVIDENCE)</brief_title>
    <acronym>PROVIDENCE</acronym>
    <official_title>A Multimodal Intervention Program to Improve Sexual Health and Self-perceived Quality of Life in Patients Treated for Cervical Cancer: a Randomized Prospective Study (PROVIDENCE Trial)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hospital Clinic of Barcelona</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Hospital Universitario 12 de Octubre</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Hospital Clinic of Barcelona</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The PROVIDENCE Trial aims to explore the improvement of sexual health and self-perceived&#xD;
        health related quality of life (measured by Patient Reported Outcome Measures) through a&#xD;
        multimodal intervention that includes patient education on healthy habits and the prevention&#xD;
        of vaginal dysfunction using vaginal moisturizers and topical estrogens. To achieve this, a&#xD;
        randomized design is proposed to assess sexual health and quality of life in patients treated&#xD;
        for cervical cancer who undergo this intervention compared to those who receive standard&#xD;
        care.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Cervical cancer treatment, both radical hysterectomy and chemoradiotherapy, can impair all&#xD;
        scopes of daily life and, beyond the physical changes caused by treatment, has psychological&#xD;
        and social implications that influence health-related quality of life (HR-QoL). Patients&#xD;
        undergoing treatment for cervical cancer have shown to score less in HR-QoL scales compared&#xD;
        to healthy women. More than half of women with gynecological cancer experience sexual&#xD;
        dysfunction, especially those affected by cervical cancer. In spite of the latest 2023&#xD;
        ESGO/ESTRO/ESP recommendations on the management of cervical cancer, several observational&#xD;
        studies indicate that the percentage of cervical cancer patients receiving information and&#xD;
        treatment for early menopause and sexual dysfunction, especially regarding hormone&#xD;
        replacement therapy, does not exceed 50%.&#xD;
  &#xD;
        The PROVIDENCE trial is a multi-institutional, national, randomized clinical trial which aims&#xD;
        to demonstrate that a multimodal intervention including patient education on sexuality and&#xD;
        healthy habits and the prevention of vaginal dysfunction reduces sexual disfunction and&#xD;
        HR-QoL impairment in patients treated for cervical cancer. The recruitment period is&#xD;
        scheduled from January 2024 to December 2026 and will be held in Gynecology Oncology Units of&#xD;
        referral hospitals in Spain.&#xD;
  &#xD;
        Patients will be randomized 1:1 at diagnosis of cervical cancer to control arm or&#xD;
        intervention arm. After treatment for initial or locally advanced cervical cancer, patients&#xD;
        in the control arm will undergo the standard follow-up and treatment of post-treatment&#xD;
        morbidity will be performed following the standard procedures as determined by their&#xD;
        referring physician. The proposed multimodal intervention for patients assigned to the&#xD;
        intervention group (detailed below) includes education on healthy habits, the prevention of&#xD;
        vaginal dysfunction using vaginal moisturizers and topical estrogens, and a systematic&#xD;
        evaluation of the need of hormone replacement therapy.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 2024</start_date>
    <completion_date type="Anticipated">April 2025</completion_date>
    <primary_completion_date type="Anticipated">February 2025</primary_completion_date>
    <phase>Phase 4</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>prospective, multi-institutional, national, randomized clinical trial with two parallel arms.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>FSFI score</measure>
      <time_frame>12 months after completion of primary treatment for cervical cancer</time_frame>
      <description>global score in FSFI (Female Sexual Function Index) questionnaire</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>FSFI (6 months)</measure>
      <time_frame>6 months after completion of primary treatment for cervical cancer</time_frame>
      <description>global score in FSFI (Female Sexual Function Index) questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EORTC QLQ-30</measure>
      <time_frame>12 months after completion of primary treatment for cervical cancer</time_frame>
      <description>global score in EORTC (European Organisation for Research and Treatment of Cancer) QLQ-30 questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EORTC QLQ-30 (6 months)</measure>
      <time_frame>6 months after completion of primary treatment for cervical cancer</time_frame>
      <description>global score in EORTC QLQ-30 questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EORTC Cx-24 (6 months)</measure>
      <time_frame>6 months after completion of primary treatment for cervical cancer</time_frame>
      <description>global score in EORTC Cx-24 questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EORTC Cx-24</measure>
      <time_frame>12 months after completion of primary treatment for cervical cancer</time_frame>
      <description>global score in EORTC Cx-24 questionnaire</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">122</enrollment>
    <condition>Cervical Cancer</condition>
    <condition>Sexual Dysfunction</condition>
    <condition>Quality of Life</condition>
    <arm_group>
      <arm_group_label>Multimodal Intervention Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Multimodal Intervention on sexual dysfunction and quality-of-life after treatment for cervical cancer: application of topical vaginal estrogens, systematic evaluation of the need of systemic hormone replacement therapy (and treatment if needed), application of hormone-free vaginal-vulvar moisturizing cream containing hyaluronic acid, use of a vaginal vibrator twice a week for 5 to 10 minutes each time with the help of intimate lubricant, access to online informational content about sexuality, access to online informational content about nutrition, access to online informational content about sports, access to online informational content about lifestyle habits</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard Care Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Standard follow-up in Gynecological Oncology Units of participating centers after treatment for cervical cancer</description>
    </arm_group>
    <intervention>
      <intervention_type>Combination Product</intervention_type>
      <intervention_name>Multimodal intervention on sexual dysfunction and quality-of-life</intervention_name>
      <description>Multimodal intervention includes education on healthy habits, the prevention of vaginal dysfunction using vaginal moisturizers and topical estrogens, and a systematic evaluation of the need of hormone replacement therapy.</description>
      <arm_group_label>Multimodal Intervention Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Women older that 18 years, with initial or locally advanced primary cervical cancer&#xD;
  &#xD;
            -  Squamous, adenocarcinoma or adenosquamous histology&#xD;
  &#xD;
            -  Stage I-III cervical cancer treated with surgery and/or radiotherapy ± systemic&#xD;
               treatment in - Gynecology Oncology Units of referral hospitals in Spain&#xD;
  &#xD;
            -  Signed informed consent by the patient or legal guardian&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Women younger tan 18 years&#xD;
  &#xD;
            -  Pregnancy or breastfeeding&#xD;
  &#xD;
            -  Patients with intraepithelial lesions of cervix uteri without invasive disease&#xD;
  &#xD;
            -  Metastatic tumor in the cervix uteri or primary tumor with atypical histology&#xD;
  &#xD;
            -  Inability to complete the questionnaires included in the study protocol&#xD;
  &#xD;
            -  Contraindications for the use of topical vaginal estrogens&#xD;
  &#xD;
            -  Patients undergoing fertility-preservation treatment (conization or trachelectomy)&#xD;
  &#xD;
            -  Patients undergoing palliative treatment&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Blanca Gil-Ibáñez, MD, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Hospital Universitario 12 de Octubre</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Berta Díaz-Feijoo, MD, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Hospital Clinic of Barcelona</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Berta Díaz-Feijoo, MD, PhD</last_name>
      <phone>932 27 54 00</phone>
      <email>bdiazfe@clinic.cat</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Blanca Gil-Ibáñez, MD, PhD</last_name>
      <email>blanca.gil@salud.madrid.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Hospital Clínic de Barcelona</name>
        <address>
          <city>Barcelona</city>
          <zip>08036</zip>
          <country>Spain</country>
        </address>
      </facility>
      <contact>
        <last_name>Núria Carreras, MD PhD</last_name>
        <email>ncarreras@clinic.cat</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hospital Universitario 12 de Octubre</name>
        <address>
          <city>Madrid</city>
          <zip>28041</zip>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>September 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>cervical cancer</keyword>
    <keyword>sexual dysfunction</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Uterine Cervical Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06031493
  org study id: PROVIDENCE
  nct id: NCT06031493
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The PROVIDENCE Trial aims to explore the improvement of sexual health and self-perceived
        health related quality of life (measured by Patient Reported Outcome Measures) through a
        multimodal intervention that includes patient education on healthy habits and the prevention
        of vaginal dysfunction using vaginal moisturizers and topical estrogens. To achieve this, a
        randomized design is proposed to assess sexual health and quality of life in patients treated
        for cervical cancer who undergo this intervention compared to those who receive standard
        care.
  Cervical cancer treatment, both radical hysterectomy and chemoradiotherapy, can impair all
        scopes of daily life and, beyond the physical changes caused by treatment, has psychological
        and social implications that influence health-related quality of life (HR-QoL). Patients
        undergoing treatment for cervical cancer have shown to score less in HR-QoL scales compared
        to healthy women. More than half of women with gynecological cancer experience sexual
        dysfunction, especially those affected by cervical cancer. In spite of the latest 2023
        ESGO/ESTRO/ESP recommendations on the management of cervical cancer, several observational
        studies indicate that the percentage of cervical cancer patients receiving information and
        treatment for early menopause and sexual dysfunction, especially regarding hormone
        replacement therapy, does not exceed 50%.
  
        The PROVIDENCE trial is a multi-institutional, national, randomized clinical trial which aims
        to demonstrate that a multimodal intervention including patient education on sexuality and
        healthy habits and the prevention of vaginal dysfunction reduces sexual disfunction and
        HR-QoL impairment in patients treated for cervical cancer. The recruitment period is
        scheduled from January 2024 to December 2026 and will be held in Gynecology Oncology Units of
        referral hospitals in Spain.
  
        Patients will be randomized 1:1 at diagnosis of cervical cancer to control arm or
        intervention arm. After treatment for initial or locally advanced cervical cancer, patients
        in the control arm will undergo the standard follow-up and treatment of post-treatment
        morbidity will be performed following the standard procedures as determined by their
        referring physician. The proposed multimodal intervention for patients assigned to the
        intervention group (detailed below) includes education on healthy habits, the prevention of
        vaginal dysfunction using vaginal moisturizers and topical estrogens, and a systematic
        evaluation of the need of hormone replacement therapy.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: prospective, multi-institutional, national, randomized clinical trial with two parallel arms.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: FSFI score
  time frame: 12 months after completion of primary treatment for cervical cancer
  description: global score in FSFI (Female Sexual Function Index) questionnaire
  measure: FSFI (6 months)
  time frame: 6 months after completion of primary treatment for cervical cancer
  description: global score in FSFI (Female Sexual Function Index) questionnaire
  measure: EORTC QLQ-30
  time frame: 12 months after completion of primary treatment for cervical cancer
  description: global score in EORTC (European Organisation for Research and Treatment of Cancer) QLQ-30 questionnaire
  measure: EORTC QLQ-30 (6 months)
  time frame: 6 months after completion of primary treatment for cervical cancer
  description: global score in EORTC QLQ-30 questionnaire
  measure: EORTC Cx-24 (6 months)
  time frame: 6 months after completion of primary treatment for cervical cancer
  description: global score in EORTC Cx-24 questionnaire
  measure: EORTC Cx-24
  time frame: 12 months after completion of primary treatment for cervical cancer
  description: global score in EORTC Cx-24 questionnaire
  arm group label: Multimodal Intervention Group
  arm group type: Experimental
  description: Multimodal Intervention on sexual dysfunction and quality-of-life after treatment for cervical cancer: application of topical vaginal estrogens, systematic evaluation of the need of systemic hormone replacement therapy (and treatment if needed), application of hormone-free vaginal-vulvar moisturizing cream containing hyaluronic acid, use of a vaginal vibrator twice a week for 5 to 10 minutes each time with the help of intimate lubricant, access to online informational content about sexuality, access to online informational content about nutrition, access to online informational content about sports, access to online informational content about lifestyle habits
  arm group label: Standard Care Group
  arm group type: No Intervention
  description: Standard follow-up in Gynecological Oncology Units of participating centers after treatment for cervical cancer
  intervention type: Combination Product
  intervention name: Multimodal intervention on sexual dysfunction and quality-of-life
  description: Multimodal intervention includes education on healthy habits, the prevention of vaginal dysfunction using vaginal moisturizers and topical estrogens, and a systematic evaluation of the need of hormone replacement therapy.
  arm group label: Multimodal Intervention Group
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Blanca Gil-Ibáñez, MD, PhD
  role: Study Director
  affiliation: Hospital Universitario 12 de Octubre
  last name: Berta Díaz-Feijoo, MD, PhD
  role: Study Director
  affiliation: Hospital Clinic of Barcelona
  last name: Berta Díaz-Feijoo, MD, PhD
  phone: 932 27 54 00
  email: bdiazfe@clinic.cat
  last name: Blanca Gil-Ibáñez, MD, PhD
  email: blanca.gil@salud.madrid.org
  facility: 
  contact: 
  facility: 
  country: Spain
  responsible party type: Sponsor
  mesh term: Uterine Cervical Neoplasms
  sharing ipd: Undecided