<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/NCT03803696</url>
  </required_header>
  <id_info>
    <org_study_id>18-543</org_study_id>
    <nct_id>NCT03803696</nct_id>
  </id_info>
  <brief_title>Multimodal Sexual Dysfunction Intervention In HCT</brief_title>
  <official_title>Randomized Trial of a Multimodal Sexual Dysfunction Intervention for Hematopoietic Stem Cell Transplant Survivors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Cancer Society, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Leukemia and Lymphoma Society</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</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>
      This research study is evaluating the impact of an intervention to improve sexual function in&#xD;
      stem cell transplant survivors on participants' sexual function, quality of life, and mood.&#xD;
&#xD;
      It is expected that about 230 people who have undergone a stem cell transplant will take part&#xD;
      in this research study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Frequently survivors of stem cell transplantation report significant problems with their&#xD;
      sexual function that impacts their quality of life, mood, and their intimacy and relationship&#xD;
      with their partners. These issues can be very distressing to patients and their loved ones.&#xD;
      The Investigators want to know if the introduction of an intervention focused on improving&#xD;
      sexual function may improve a participant's overall care and quality of life.&#xD;
&#xD;
      The main purpose of this study is to compare two types of care - the study intervention&#xD;
      versus enhanced standard care which includes receiving an educational handout about sexual&#xD;
      dysfunction. The main goal is to assess if the intervention will improve participant's sexual&#xD;
      function, quality of life, and mood.&#xD;
&#xD;
      The intervention includes a comprehensive assessment by a transplant clinician (a transplant&#xD;
      physician or nurse practitioner) who is trained in sexual dysfunction assessment to explore&#xD;
      the reasons for sexual dysfunction and focus on ways to improve symptoms.&#xD;
&#xD;
      -- If the transplant clinician feels additional help is needed by a sexual health expert, the&#xD;
      participant will be referred to the sexual health clinic. In the sexual health clinic, the&#xD;
      participant will be evaluated by an expert physician who will also focus on strategies to&#xD;
      improve sexual function.&#xD;
&#xD;
      The study will use a series of questionnaires to measure sexual function, quality of life,&#xD;
      physical symptoms, and mood. Study questionnaires will be completed in the clinic or remotely&#xD;
      with assistance provided as needed.&#xD;
&#xD;
      .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2024</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Compare Patient Global Satisfaction with Sex</measure>
    <time_frame>3 Months</time_frame>
    <description>compare patients' global satisfaction with sex using PROMIS Sexual Function and Satisfaction Measure (global satisfaction domain) at three months between the study groups using linear regression controlling for baseline values (as necessary for any imbalances in baseline variables</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compare Patient reported interest in sexual activity</measure>
    <time_frame>3 Months</time_frame>
    <description>PROMIS Sexual Function and Satisfaction Measure Interest in sexual activity domain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare Patient global satisfaction with sex longitudinally</measure>
    <time_frame>up to 9 months</time_frame>
    <description>compare PROMIS Sexual function and Satisfaction Measure - global satisfaction with sex domain) longitudinally between study groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare Patient reported interest in sexual activity longitudinally</measure>
    <time_frame>up to 9 months</time_frame>
    <description>compare PROMIS Sexual Function and Satisfaction Measure Interest in sexual activity domain) longitudinally between study groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare patient-reported orgasm</measure>
    <time_frame>3 Months</time_frame>
    <description>Compare PROMIS Sexual Function and Satisfaction Measure - Orgasm domain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare patient-reported orgasm longitudinally</measure>
    <time_frame>up to 9 months</time_frame>
    <description>Compare PROMIS Sexual Function and Satisfaction Measure - Orgasm domain) longitudinally between the study groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>For males: compare patient-reported erectile function</measure>
    <time_frame>3 Months</time_frame>
    <description>PROMIS Sexual Function and Satisfaction Measure - Erectile function domain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>For males: compare patient-reported erectile function longitudinally</measure>
    <time_frame>up to 9 months</time_frame>
    <description>Compare PROMIS Sexual Function and Satisfaction Measure - Erectile function domain longitudinally between the two groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>For females: compare patient-reported vaginal lubrication</measure>
    <time_frame>3 Months</time_frame>
    <description>compare (PROMIS Sexual Function and Satisfaction Measure - lubrication domain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>For females: compare patient-reported vaginal lubrication longitudinally</measure>
    <time_frame>up to 9 months</time_frame>
    <description>compare (PROMIS Sexual Function and Satisfaction Measure - lubrication domain) longitudinally between the two study groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>For females: compare patient-reported vaginal comfort</measure>
    <time_frame>3 months</time_frame>
    <description>compare (PROMIS Sexual Function and Satisfaction Measure - vaginal comfort domain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>For females: compare patient-reported vaginal comfort longitudinally</measure>
    <time_frame>up to 9 months</time_frame>
    <description>compare (PROMIS Sexual Function and Satisfaction Measure - vaginal comfort domain) longitudinally between the two study groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare Patient Reported Quality of Life</measure>
    <time_frame>3 Months</time_frame>
    <description>Compare patient-reported QOL using the Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare Patient Reported Quality of Life longitudinally</measure>
    <time_frame>up to 9 months</time_frame>
    <description>Compare patient-reported QOL using the Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT) longitudinally between the two groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare Patient Reported Anxiety Symptoms</measure>
    <time_frame>3 Months</time_frame>
    <description>Compare patient reported anxiety symptoms using the Hospital Anxiety and Depression Scale (HADS- anxiety subscale). Subscale ranges from 0-21 with higher score indicating higher anxiety symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare Patient Reported Anxiety Symptoms Longitudinally</measure>
    <time_frame>up to 9 months</time_frame>
    <description>Compare patient reported anxiety symptoms using the Hospital Anxiety and Depression Scale (HADS- anxiety subscale) longitudinally between the two study groups. Subscale ranges from 0-21 with higher score indicating higher anxiety symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare Patient Reported Depression Symptoms</measure>
    <time_frame>3 Months</time_frame>
    <description>Compare Patient Reported Depression Symptoms using the Hospital Anxiety and Depression Scale (HADS - depression subscale). Subscale ranges from 0-21 with higher score indicating higher depression symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare Patient Reported Depression Symptoms Longitudinally</measure>
    <time_frame>up to 9 Months</time_frame>
    <description>Compare Patient Reported Depression Symptoms using the Hospital Anxiety and Depression Scale (HADS - depression subscale) longitudinally between the two study groups. Subscale ranges from 0-21 with higher score indicating higher depression symptoms</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">230</enrollment>
  <condition>Hematopoietic Stem Cell Transplantation</condition>
  <condition>Hematologic Diseases</condition>
  <condition>Sexual Dysfunction</condition>
  <arm_group>
    <arm_group_label>Enhanced Standard Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Baseline data collection, registration and randomization&#xD;
Inform primary transplant clinician of sexual dysfunction causing distress&#xD;
Receive American Cancer Society sexual educational material</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multimodal Intervention to Address Sexual Dysfunction</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Baseline data collection, registration and randomization&#xD;
3 Monthly visits with trained study nurse practitioners&#xD;
Referral to specialist if&#xD;
Psychological etiology&#xD;
Sexual Trauma&#xD;
Relationship Discord&#xD;
Concern for Malignancy or anatomic scarring requiring surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Enhanced Standard Care</intervention_name>
    <description>Baseline data collection, registration and randomization&#xD;
Inform primary transplant clinician of sexual dysfunction causing distress&#xD;
Receive American Cancer Society sexual educational material</description>
    <arm_group_label>Enhanced Standard Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Multimodal Intervention to Address Sexual Dysfunction</intervention_name>
    <description>Baseline data collection, registration and randomization&#xD;
- 3 Monthly visits with trained study nurse practitioners&#xD;
Referral to specialist if&#xD;
Psychological etiology&#xD;
Sexual Trauma&#xD;
Relationship Discord&#xD;
Concern for Malignancy or anatomic scarring requiring surgery</description>
    <arm_group_label>Multimodal Intervention to Address Sexual Dysfunction</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients (≥ 18 years) with hematologic malignancy who underwent autologous or&#xD;
             allogeneic HCT ≥ three months prior to study enrollment.&#xD;
&#xD;
          -  Positive screen for sexual dysfunction that is causing distress based on the National&#xD;
             Comprehensive Cancer Network (NCCN) survivorship guidelines&#xD;
&#xD;
          -  Ability to read and respond to questions in English or to complete questionnaires with&#xD;
             assistance from an interpreter.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with relapsed disease requiring treatment&#xD;
&#xD;
          -  Patients with a planned second transplant&#xD;
&#xD;
          -  Patients &gt; 5 years from their HCT&#xD;
&#xD;
          -  Patients with psychiatric or cognitive conditions which the treating clinicians&#xD;
             believes prohibits compliance with study procedures.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Areej El-Jawhri, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Areej El-Jawhri, MD</last_name>
    <phone>617-643-4003</phone>
    <email>ael-jawahri@partners.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Areej El-Jawahri, MD</last_name>
      <phone>617-643-4003</phone>
    </contact>
    <investigator>
      <last_name>Areej El-Jawahri, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>August 23, 2022</last_update_submitted>
  <last_update_submitted_qc>August 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>El-Jawahri, Areej,M.D.</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Hematopoietic Stem Cell Transplantation</keyword>
  <keyword>Hematologic Diseases</keyword>
  <keyword>Sexual Dysfunction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hematologic Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Data can be shared no earlier than 1 year following the date of publication.</ipd_time_frame>
    <ipd_access_criteria>Requests may be directed to:MGH - Contact the Partners Innovations team at http://www.partners.org/innovation</ipd_access_criteria>
  </patient_data>
  <!-- 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/NCT03803696
org study id: 18-543
nct id: NCT03803696
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This research study is evaluating the impact of an intervention to improve sexual function in
      stem cell transplant survivors on participants' sexual function, quality of life, and mood.

      It is expected that about 230 people who have undergone a stem cell transplant will take part
      in this research study.
Frequently survivors of stem cell transplantation report significant problems with their
      sexual function that impacts their quality of life, mood, and their intimacy and relationship
      with their partners. These issues can be very distressing to patients and their loved ones.
      The Investigators want to know if the introduction of an intervention focused on improving
      sexual function may improve a participant's overall care and quality of life.

      The main purpose of this study is to compare two types of care - the study intervention
      versus enhanced standard care which includes receiving an educational handout about sexual
      dysfunction. The main goal is to assess if the intervention will improve participant's sexual
      function, quality of life, and mood.

      The intervention includes a comprehensive assessment by a transplant clinician (a transplant
      physician or nurse practitioner) who is trained in sexual dysfunction assessment to explore
      the reasons for sexual dysfunction and focus on ways to improve symptoms.

      -- If the transplant clinician feels additional help is needed by a sexual health expert, the
      participant will be referred to the sexual health clinic. In the sexual health clinic, the
      participant will be evaluated by an expert physician who will also focus on strategies to
      improve sexual function.

      The study will use a series of questionnaires to measure sexual function, quality of life,
      physical symptoms, and mood. Study questionnaires will be completed in the clinic or remotely
      with assistance provided as needed.

      .
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Compare Patient Global Satisfaction with Sex
time frame: 3 Months
description: compare patients' global satisfaction with sex using PROMIS Sexual Function and Satisfaction Measure (global satisfaction domain) at three months between the study groups using linear regression controlling for baseline values (as necessary for any imbalances in baseline variables
measure: Compare Patient reported interest in sexual activity
time frame: 3 Months
description: PROMIS Sexual Function and Satisfaction Measure Interest in sexual activity domain)
measure: Compare Patient global satisfaction with sex longitudinally
time frame: up to 9 months
description: compare PROMIS Sexual function and Satisfaction Measure - global satisfaction with sex domain) longitudinally between study groups
measure: Compare Patient reported interest in sexual activity longitudinally
time frame: up to 9 months
description: compare PROMIS Sexual Function and Satisfaction Measure Interest in sexual activity domain) longitudinally between study groups
measure: Compare patient-reported orgasm
time frame: 3 Months
description: Compare PROMIS Sexual Function and Satisfaction Measure - Orgasm domain
measure: Compare patient-reported orgasm longitudinally
time frame: up to 9 months
description: Compare PROMIS Sexual Function and Satisfaction Measure - Orgasm domain) longitudinally between the study groups
measure: For males: compare patient-reported erectile function
time frame: 3 Months
description: PROMIS Sexual Function and Satisfaction Measure - Erectile function domain
measure: For males: compare patient-reported erectile function longitudinally
time frame: up to 9 months
description: Compare PROMIS Sexual Function and Satisfaction Measure - Erectile function domain longitudinally between the two groups
measure: For females: compare patient-reported vaginal lubrication
time frame: 3 Months
description: compare (PROMIS Sexual Function and Satisfaction Measure - lubrication domain)
measure: For females: compare patient-reported vaginal lubrication longitudinally
time frame: up to 9 months
description: compare (PROMIS Sexual Function and Satisfaction Measure - lubrication domain) longitudinally between the two study groups
measure: For females: compare patient-reported vaginal comfort
time frame: 3 months
description: compare (PROMIS Sexual Function and Satisfaction Measure - vaginal comfort domain
measure: For females: compare patient-reported vaginal comfort longitudinally
time frame: up to 9 months
description: compare (PROMIS Sexual Function and Satisfaction Measure - vaginal comfort domain) longitudinally between the two study groups
measure: Compare Patient Reported Quality of Life
time frame: 3 Months
description: Compare patient-reported QOL using the Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT)
measure: Compare Patient Reported Quality of Life longitudinally
time frame: up to 9 months
description: Compare patient-reported QOL using the Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT) longitudinally between the two groups
measure: Compare Patient Reported Anxiety Symptoms
time frame: 3 Months
description: Compare patient reported anxiety symptoms using the Hospital Anxiety and Depression Scale (HADS- anxiety subscale). Subscale ranges from 0-21 with higher score indicating higher anxiety symptoms
measure: Compare Patient Reported Anxiety Symptoms Longitudinally
time frame: up to 9 months
description: Compare patient reported anxiety symptoms using the Hospital Anxiety and Depression Scale (HADS- anxiety subscale) longitudinally between the two study groups. Subscale ranges from 0-21 with higher score indicating higher anxiety symptoms
measure: Compare Patient Reported Depression Symptoms
time frame: 3 Months
description: Compare Patient Reported Depression Symptoms using the Hospital Anxiety and Depression Scale (HADS - depression subscale). Subscale ranges from 0-21 with higher score indicating higher depression symptoms
measure: Compare Patient Reported Depression Symptoms Longitudinally
time frame: up to 9 Months
description: Compare Patient Reported Depression Symptoms using the Hospital Anxiety and Depression Scale (HADS - depression subscale) longitudinally between the two study groups. Subscale ranges from 0-21 with higher score indicating higher depression symptoms
arm group label: Enhanced Standard Care
arm group type: Active Comparator
description: Baseline data collection, registration and randomization
Inform primary transplant clinician of sexual dysfunction causing distress
Receive American Cancer Society sexual educational material
arm group label: Multimodal Intervention to Address Sexual Dysfunction
arm group type: Active Comparator
description: Baseline data collection, registration and randomization
3 Monthly visits with trained study nurse practitioners
Referral to specialist if
Psychological etiology
Sexual Trauma
Relationship Discord
Concern for Malignancy or anatomic scarring requiring surgery
intervention type: Behavioral
intervention name: Enhanced Standard Care
description: Baseline data collection, registration and randomization
Inform primary transplant clinician of sexual dysfunction causing distress
Receive American Cancer Society sexual educational material
arm group label: Enhanced Standard Care
intervention type: Behavioral
intervention name: Multimodal Intervention to Address Sexual Dysfunction
description: Baseline data collection, registration and randomization
- 3 Monthly visits with trained study nurse practitioners
Referral to specialist if
Psychological etiology
Sexual Trauma
Relationship Discord
Concern for Malignancy or anatomic scarring requiring surgery
arm group label: Multimodal Intervention to Address Sexual Dysfunction
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Areej El-Jawhri, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
last name: Areej El-Jawhri, MD
phone: 617-643-4003
email: ael-jawahri@partners.org
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: El-Jawahri, Areej,M.D.
investigator title: Principal Investigator
mesh term: Hematologic Diseases
sharing ipd: Yes
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: Data can be shared no earlier than 1 year following the date of publication.
ipd access criteria: Requests may be directed to:MGH - Contact the Partners Innovations team at http://www.partners.org/innovation