<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/NCT04472104</url>
  </required_header>
  <id_info>
    <org_study_id>H19-02480</org_study_id>
    <nct_id>NCT04472104</nct_id>
  </id_info>
  <brief_title>BREast Cancer And Sexuality Treatment</brief_title>
  <acronym>BREAST</acronym>
  <official_title>Mindfulness-based Treatment for Sexual Difficulties Following Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Calgary</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of British Columbia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this project is to compare the effects of a group mindfulness treatment versus&#xD;
      a group sex education on sexual desire, sexual distress, and sexual pain in breast cancer&#xD;
      (BrCa) survivors. Participants will be randomly assigned to either 8 weekly sessions of a&#xD;
      group mindfulness-based treatment or 8 weekly sessions of a sex education group. Groups will&#xD;
      consist of approximately 8 breast cancer survivors and will be led by 2 trained therapists.&#xD;
      Participants will complete four assessments (involving a clinician administered interview and&#xD;
      standardized questions): pre-treatment, post- treatment, and 6 month follow up.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 6, 2020</start_date>
  <completion_date type="Actual">April 1, 2023</completion_date>
  <primary_completion_date type="Actual">December 1, 2022</primary_completion_date>
  <phase>N/A</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>3-year, randomized, unblinded, two-site, controlled trial of 8 weekly sessions of group Mindfulness-Based Cognitive Therapy for sexuality (MBCT-S) vs. 8 weekly sessions of a sex education treatment.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Those doing data analysis are blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>A Change from Baseline Sexual Interest and Desire Female (SIDI-F) Score at 2 weeks' post-treatment</measure>
    <time_frame>Baseline/T1 is within 2 weeks pre-treatment and T2 is within 2 weeks post-treatment</time_frame>
    <description>Sexual desire will be measured with the 13-item Sexual Interest and Desire Inventory which is a 14-item questionnaire that assesses sexual desire in women which includes one non-scored item assessing intercourse frequency. Possible total scores range from 0 - 51, with higher scores indicating higher levels of sexual functioning.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>A Change from Baseline Sexual Interest and Desire Female (SIDI-F) Score at 6 month follow-up</measure>
    <time_frame>Baseline/T1 is within 2 weeks pre-treatment and T3 is at 6 month follow-up</time_frame>
    <description>Sexual desire will be measured with the 13-item Sexual Interest and Desire Inventory which is a 14-item questionnaire that assesses sexual desire in women which includes one non-scored item assessing intercourse frequency. Possible total scores range from 0 - 51, with higher scores indicating higher levels of sexual functioning.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>No Change in Sexual Interest and Desire Female (SIDI-F) Score from 2 weeks' post-treatment (T2) and at 6 month follow-up (T3)</measure>
    <time_frame>T2 is within 2 weeks post-treatment and T3 is at 6 month follow-up</time_frame>
    <description>Sexual desire will be measured with the 13-item Sexual Interest and Desire Inventory which is a 14-item questionnaire that assesses sexual desire in women which includes one non-scored item assessing intercourse frequency. Possible total scores range from 0 - 51, with higher scores indicating higher levels of sexual functioning.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>A Change from Baseline Female Sexual Distress Scale - Revised (FSDS-R) Score at 2 weeks' post-treatment</measure>
    <time_frame>Baseline/T1 is within 2 weeks pre-treatment and T2 is within 2 weeks post-treatment</time_frame>
    <description>Sexual distress will be assessed using the Female Sexual Distress Scale - Revised which is a 13-item scale where scores on the scale range from 0 - 52, where higher scores represent higher levels of distress.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>A Change from Baseline Female Sexual Distress Scale - Revised (FSDS-R) Score at 6 month follow-up</measure>
    <time_frame>Baseline/T1 is within 2 weeks pre-treatment and T3 is at 6 month follow-up</time_frame>
    <description>Sexual distress will be assessed using the Female Sexual Distress Scale - Revised which is a 13-item scale where scores on the scale range from 0 - 52, where higher scores represent higher levels of distress.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>No Change in Female Sexual Distress Scale - Revised (FSDS-R) Score from T2 at 2 weeks' post-treatment and at 6 month follow-up</measure>
    <time_frame>T2 is within 2 weeks post-treatment and T3 is at 6 month follow-up</time_frame>
    <description>Sexual distress will be assessed using the Female Sexual Distress Scale - Revised which is a 13-item scale where scores on the scale range from 0 - 52, where higher scores represent higher levels of distress.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>A Change from Baseline Sexual Pain Rating Score at 2 weeks' post-treatment</measure>
    <time_frame>Baseline/T1 is within 2 weeks pre-treatment and T2 is within 2 weeks post-treatment</time_frame>
    <description>Numeric Rating Scale of 0-10 (from no pain to worst possible pain) in response to vaginal penetration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>A Change from Baseline Sexual Pain Rating Score at 6 month follow-up</measure>
    <time_frame>Baseline/T1 is within 2 weeks pre-treatment and T3 is at 6 month follow-up</time_frame>
    <description>Numeric Rating Scale of 0-10 (from no pain to worst possible pain) in response to vaginal penetration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>No Change in Sexual Pain Rating Score from 2 weeks' post-treatment and at 6 month follow-up</measure>
    <time_frame>T2 is within 2 weeks post-treatment and T3 is at 6 month follow-up</time_frame>
    <description>Numeric Rating Scale of 0-10 (from no pain to worst possible pain) in response to vaginal penetration.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">118</enrollment>
  <condition>Sexual Dysfunction</condition>
  <arm_group>
    <arm_group_label>MBCT-S</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Mindfulness-Based Cognitive Therapy for sexuality (MBCT-S) which incorporates several empirically supported therapeutic approaches, integrating elements of education, mindfulness meditation skills, and sex therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SexEd</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sexuality education on sexual desire, sexual distress, and sexual pain.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>MBCT-S</intervention_name>
    <description>Group mindfulness treatment for sexual desire, sexual distress, and sexual pain in breast cancer (BrCa) survivors.</description>
    <arm_group_label>MBCT-S</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SexEd</intervention_name>
    <description>Group sex education on sexual desire, sexual distress, and sexual pain in breast cancer (BrCa) survivors.</description>
    <arm_group_label>SexEd</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women over the age of majority, with a history of breast cancer and who are at least 3&#xD;
             months following the end of their treatment&#xD;
&#xD;
          -  Fluent in English&#xD;
&#xD;
          -  Exceed the clinical cut-off for sexual distress (Female Sexual Distress Scale).&#xD;
&#xD;
          -  Women who are, and who are not, in a relationship will be eligible as long as they&#xD;
             have engaged in sexual activity either alone or with a sexual partner in the past 6&#xD;
             months, or as long as they indicate a willingness to engage in sexual activity (alone&#xD;
             or with a sexual partner) during the time period of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active cancer treatment (e.g. chemotherapy or radiation, not including endocrine or&#xD;
             maintenance therapies provided they remain constant for the study duration), or&#xD;
             scheduled breast reconstruction during the study period.&#xD;
&#xD;
          -  Borderline Personality Disorder or other psychiatric or medical conditions that&#xD;
             preclude the ability to fully participate in the group sessions, assessments, and&#xD;
             homework.&#xD;
&#xD;
          -  In order to determine whether any changes in symptoms are a result of participation in&#xD;
             the intervention, women must also agree to 1) not make changes to or commence vaginal&#xD;
             interventions (e.g., topical hormone treatments, vaginal moisturizers, vaginal&#xD;
             dilation) or 2) engage in other treatments for sexual difficulties (e.g., sex&#xD;
             therapy), for 2 weeks prior to the baseline assessment until 2 weeks following the&#xD;
             final intervention session.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>UBC Sexual Health Lab, Vancouver Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5M 1M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>November 19, 2019</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>May 8, 2023</last_update_submitted>
  <last_update_submitted_qc>May 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of British Columbia</investigator_affiliation>
    <investigator_full_name>Lori Brotto</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04472104
org study id: H19-02480
nct id: NCT04472104
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this project is to compare the effects of a group mindfulness treatment versus
      a group sex education on sexual desire, sexual distress, and sexual pain in breast cancer
      (BrCa) survivors. Participants will be randomly assigned to either 8 weekly sessions of a
      group mindfulness-based treatment or 8 weekly sessions of a sex education group. Groups will
      consist of approximately 8 breast cancer survivors and will be led by 2 trained therapists.
      Participants will complete four assessments (involving a clinician administered interview and
      standardized questions): pre-treatment, post- treatment, and 6 month follow up.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 3-year, randomized, unblinded, two-site, controlled trial of 8 weekly sessions of group Mindfulness-Based Cognitive Therapy for sexuality (MBCT-S) vs. 8 weekly sessions of a sex education treatment.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Those doing data analysis are blind
measure: A Change from Baseline Sexual Interest and Desire Female (SIDI-F) Score at 2 weeks' post-treatment
time frame: Baseline/T1 is within 2 weeks pre-treatment and T2 is within 2 weeks post-treatment
description: Sexual desire will be measured with the 13-item Sexual Interest and Desire Inventory which is a 14-item questionnaire that assesses sexual desire in women which includes one non-scored item assessing intercourse frequency. Possible total scores range from 0 - 51, with higher scores indicating higher levels of sexual functioning.
measure: A Change from Baseline Sexual Interest and Desire Female (SIDI-F) Score at 6 month follow-up
time frame: Baseline/T1 is within 2 weeks pre-treatment and T3 is at 6 month follow-up
description: Sexual desire will be measured with the 13-item Sexual Interest and Desire Inventory which is a 14-item questionnaire that assesses sexual desire in women which includes one non-scored item assessing intercourse frequency. Possible total scores range from 0 - 51, with higher scores indicating higher levels of sexual functioning.
measure: No Change in Sexual Interest and Desire Female (SIDI-F) Score from 2 weeks' post-treatment (T2) and at 6 month follow-up (T3)
time frame: T2 is within 2 weeks post-treatment and T3 is at 6 month follow-up
description: Sexual desire will be measured with the 13-item Sexual Interest and Desire Inventory which is a 14-item questionnaire that assesses sexual desire in women which includes one non-scored item assessing intercourse frequency. Possible total scores range from 0 - 51, with higher scores indicating higher levels of sexual functioning.
measure: A Change from Baseline Female Sexual Distress Scale - Revised (FSDS-R) Score at 2 weeks' post-treatment
time frame: Baseline/T1 is within 2 weeks pre-treatment and T2 is within 2 weeks post-treatment
description: Sexual distress will be assessed using the Female Sexual Distress Scale - Revised which is a 13-item scale where scores on the scale range from 0 - 52, where higher scores represent higher levels of distress.
measure: A Change from Baseline Female Sexual Distress Scale - Revised (FSDS-R) Score at 6 month follow-up
time frame: Baseline/T1 is within 2 weeks pre-treatment and T3 is at 6 month follow-up
description: Sexual distress will be assessed using the Female Sexual Distress Scale - Revised which is a 13-item scale where scores on the scale range from 0 - 52, where higher scores represent higher levels of distress.
measure: No Change in Female Sexual Distress Scale - Revised (FSDS-R) Score from T2 at 2 weeks' post-treatment and at 6 month follow-up
time frame: T2 is within 2 weeks post-treatment and T3 is at 6 month follow-up
description: Sexual distress will be assessed using the Female Sexual Distress Scale - Revised which is a 13-item scale where scores on the scale range from 0 - 52, where higher scores represent higher levels of distress.
measure: A Change from Baseline Sexual Pain Rating Score at 2 weeks' post-treatment
time frame: Baseline/T1 is within 2 weeks pre-treatment and T2 is within 2 weeks post-treatment
description: Numeric Rating Scale of 0-10 (from no pain to worst possible pain) in response to vaginal penetration.
measure: A Change from Baseline Sexual Pain Rating Score at 6 month follow-up
time frame: Baseline/T1 is within 2 weeks pre-treatment and T3 is at 6 month follow-up
description: Numeric Rating Scale of 0-10 (from no pain to worst possible pain) in response to vaginal penetration.
measure: No Change in Sexual Pain Rating Score from 2 weeks' post-treatment and at 6 month follow-up
time frame: T2 is within 2 weeks post-treatment and T3 is at 6 month follow-up
description: Numeric Rating Scale of 0-10 (from no pain to worst possible pain) in response to vaginal penetration.
arm group label: MBCT-S
arm group type: Active Comparator
description: Mindfulness-Based Cognitive Therapy for sexuality (MBCT-S) which incorporates several empirically supported therapeutic approaches, integrating elements of education, mindfulness meditation skills, and sex therapy.
arm group label: SexEd
arm group type: Active Comparator
description: Sexuality education on sexual desire, sexual distress, and sexual pain.
intervention type: Behavioral
intervention name: MBCT-S
description: Group mindfulness treatment for sexual desire, sexual distress, and sexual pain in breast cancer (BrCa) survivors.
arm group label: MBCT-S
intervention type: Behavioral
intervention name: SexEd
description: Group sex education on sexual desire, sexual distress, and sexual pain in breast cancer (BrCa) survivors.
arm group label: SexEd
criteria: 
gender: Female
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of British Columbia
investigator full name: Lori Brotto
investigator title: Principal Investigator