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/NCT06041698</url>
    </required_header>
    <id_info>
      <org_study_id>iRISID-2022-1329</org_study_id>
      <nct_id>NCT06041698</nct_id>
    </id_info>
    <brief_title>Two Implementation Strategies for the Collection of Electronic Patient-Reported Outcomes Among Patients With Multiple Myeloma</brief_title>
    <official_title>Testing Two Implementation Strategies in Collecting ePRO Among Multiple Myeloma Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Thomas Jefferson University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Thomas Jefferson University</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 clinical trial evaluates satisfaction and engagement with a text messaging platform&#xD;
        (TXT-Chatbot) compared to a patient portal system (MyChart/Patient Portal) for reporting&#xD;
        symptoms among patients with multiple myeloma (MM). Multiple myeloma is the third most common&#xD;
        hematologic (relating to the blood and blood-forming organs) cancer. Patients with MM&#xD;
        typically receive continuous therapy from the time of diagnosis, which often comes with&#xD;
        treatment-related toxicities. Symptom burden and health-related quality of life (HRQOL) for&#xD;
        those with MM can be quite poor. Effects of MM and its treatment may impact HRQOL domains&#xD;
        such as physical and emotional well-being, social functioning, and financial burden.&#xD;
        Assessment of toxicities through patient-reported outcome (PRO) measures is critical and can&#xD;
        generate information to help facilitate clinical decision making and follow up care. PROs are&#xD;
        direct reports from patients about their health status. Compared with paper versions,&#xD;
        electronic PROs (ePRO) allow patients to report their symptoms in real time outside of their&#xD;
        clinic visit, facilitate direct data collection through the electronic health record, and&#xD;
        enable clinicians to track symptoms long-term. The use of ePROs is associated with improved&#xD;
        patient health outcomes, including better quality of life, reduced emergency department&#xD;
        usage, and prolonged overall survival. The increased use of electronic communication&#xD;
        technologies to capture PRO data long-term has been implemented through various methods&#xD;
        including web-based, social media, text messages, mobile applications, and electronic&#xD;
        portals. Text messaging is an accessible, though under-explored, communication channel for&#xD;
        promoting ePRO collection. Information gathered from this study may help researchers&#xD;
        understand MM patients' preferences for reporting symptoms via text message compared to a&#xD;
        patient portal system.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        PRIMARY OBJECTIVES:&#xD;
  &#xD;
        I. To evaluate the patients' preference of TXT-Chatbot approach versus MyChart/Patient Portal&#xD;
        approach, considering their demographic information.&#xD;
  &#xD;
        II. To evaluate each patient's adherence to the approach of his/her own choice by examining&#xD;
        their utilization of the ePRO.&#xD;
  &#xD;
        SECONDARY OBJECTIVE:&#xD;
  &#xD;
        I. To examine the usability and satisfaction of the two implementation approaches of each&#xD;
        patient's choice.&#xD;
  &#xD;
        EXPLORATORY OBJECTIVE:&#xD;
  &#xD;
        I. To explore and measure any differences in patients' preference of TXT-Chatbot approach&#xD;
        versus MyChart/Patient Portal approach, as well as the number of completed of ePRO responses,&#xD;
        in the course of 6 months, reported between race (African American versus [vs.] Caucasian)&#xD;
        and approaches (Chatbot vs. MyChart/Patient Portal).&#xD;
  &#xD;
        OUTLINE: Patients are assigned to 1 of 2 groups.&#xD;
  &#xD;
        GROUP I: Patients receive a text message notification and complete surveys through&#xD;
        TXT-Chatbot once every two weeks (Q2W) for 6 months.&#xD;
  &#xD;
        GROUP II: Patients receive an email notification and complete surveys through MyChart/Patient&#xD;
        Portal Q2W for 6 months.&#xD;
  &#xD;
        After completion of study intervention, patients are followed up for 30 days.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 13, 2023</start_date>
    <completion_date type="Anticipated">December 2025</completion_date>
    <primary_completion_date type="Anticipated">June 1, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Choice of TXT-Chatbot</measure>
      <time_frame>Up to 6 months</time_frame>
      <description>The choice of implementation approaches will be summarized using percentages. Multivariable logistic regression analysis will be performed to explore the relationship between the choice of approaches and age, gender, etc.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of completed electronic Patient-Reported Outcome (ePRO) responses</measure>
      <time_frame>Up to 6 months</time_frame>
      <description>The number of completed ePRO responses, over the course of 6 months, will be summarized using means and standard deviations, for the two implementation approaches. Multivariable Poisson regression analysis will be performed to explore the relationship between this endpoint and implementation approaches, age, gender, etc., with special consideration of the interaction between race (African American versus Caucasian) and implementation approaches.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Overall Satisfaction Scores Using the Client Satisfaction Questionnaire (CSQ-8)</measure>
      <time_frame>At 6 months</time_frame>
      <description>Participants will complete the Client Satisfaction Questionnaire (CSQ-8), a validated measure that elicits the client's perspective on the value of services received. The 8 items are rated on a 1-5 scale with higher scores indicating greater satisfaction. The overall satisfaction score will be summarized using means and standard deviations across the 8 items. The dichotomized satisfaction score (overall score ≥ 3.5) will be summarized using percentages . Multivariable (non-)linear and logistic regression models will be performed to explore the relationship between the endpoints and implementation approaches, age, gender, and other measures.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Multiple Myeloma</condition>
    <arm_group>
      <arm_group_label>Group I (TXT-Chatbot )</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients receive a text message notification and complete surveys through TXT-Chatbot Q2W for 6 months.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group II (MyChart/Patient Portal)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients receive an email notification and complete surveys through MyChart/Patient Portal Q2W for 6 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Planned Notification</intervention_name>
      <description>Receive text notification</description>
      <arm_group_label>Group I (TXT-Chatbot )</arm_group_label>
      <other_name>PlannedNotification</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Survey Administration</intervention_name>
      <description>Complete surveys</description>
      <arm_group_label>Group I (TXT-Chatbot )</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Behavioral Intervention</intervention_name>
      <description>Participate in TXT-Chatbot</description>
      <arm_group_label>Group I (TXT-Chatbot )</arm_group_label>
      <other_name>Behavior Conditioning Therapy</other_name>
      <other_name>behavior modification</other_name>
      <other_name>Behavior or Life Style Modifications</other_name>
      <other_name>Behavior Therapy</other_name>
      <other_name>Behavioral Interventions</other_name>
      <other_name>Behavioral Modification</other_name>
      <other_name>BEHAVIORAL THERAPY</other_name>
      <other_name>Behavioral Treatment</other_name>
      <other_name>Behavioral Treatments</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Electronic Health Record Review</intervention_name>
      <description>Ancillary studies</description>
      <arm_group_label>Group I (TXT-Chatbot )</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Interview</intervention_name>
      <description>Ancillary studies</description>
      <arm_group_label>Group I (TXT-Chatbot )</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Survey Administration</intervention_name>
      <description>Complete surveys</description>
      <arm_group_label>Group II (MyChart/Patient Portal)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Planned Notification</intervention_name>
      <description>Receive email notification</description>
      <arm_group_label>Group II (MyChart/Patient Portal)</arm_group_label>
      <other_name>PlannedNotification</other_name>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Behavioral Intervention</intervention_name>
      <description>Participate in MyChart/Patient Portal</description>
      <arm_group_label>Group II (MyChart/Patient Portal)</arm_group_label>
      <other_name>Behavior Conditioning Therapy</other_name>
      <other_name>behavior modification</other_name>
      <other_name>Behavior or Life Style Modifications</other_name>
      <other_name>Behavior Therapy</other_name>
      <other_name>Behavioral Interventions</other_name>
      <other_name>Behavioral Modification</other_name>
      <other_name>BEHAVIORAL THERAPY</other_name>
      <other_name>Behavioral Treatment</other_name>
      <other_name>Behavioral Treatments</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Electronic Health Record Review</intervention_name>
      <description>Ancillary studies</description>
      <arm_group_label>Group II (MyChart/Patient Portal)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Interview</intervention_name>
      <description>Ancillary studies</description>
      <arm_group_label>Group II (MyChart/Patient Portal)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of MM&#xD;
  &#xD;
            -  Able to use TXT or have Internet access&#xD;
  &#xD;
            -  Can read and understand English&#xD;
  &#xD;
            -  If patients are undergoing an autologous stem cell transplant, they will be enrolled&#xD;
               after their transplant&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  &lt; 18 years of age&#xD;
  &#xD;
            -  Cognitive impairment documented in the electronic medical record (EMR)&#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_contact>
      <last_name>Kuang-Yi Wen, PhD</last_name>
      <phone>215-503-4623</phone>
      <email>Kuang-Yi.Wen@Jefferson.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Sidney Kimmel Cancer Center at Thomas Jefferson University</name>
        <address>
          <city>Philadelphia</city>
          <state>Pennsylvania</state>
          <zip>19107</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Kuang-Yi Wen, MD</last_name>
        <phone>215-503-4623</phone>
        <email>Kuang-Yi.Wen@Jefferson.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Multiple Myeloma</mesh_term>
      <mesh_term>Neoplasms, Plasma Cell</mesh_term>
    </condition_browse>
    <!-- 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/NCT06041698
  org study id: iRISID-2022-1329
  nct id: NCT06041698
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This clinical trial evaluates satisfaction and engagement with a text messaging platform
        (TXT-Chatbot) compared to a patient portal system (MyChart/Patient Portal) for reporting
        symptoms among patients with multiple myeloma (MM). Multiple myeloma is the third most common
        hematologic (relating to the blood and blood-forming organs) cancer. Patients with MM
        typically receive continuous therapy from the time of diagnosis, which often comes with
        treatment-related toxicities. Symptom burden and health-related quality of life (HRQOL) for
        those with MM can be quite poor. Effects of MM and its treatment may impact HRQOL domains
        such as physical and emotional well-being, social functioning, and financial burden.
        Assessment of toxicities through patient-reported outcome (PRO) measures is critical and can
        generate information to help facilitate clinical decision making and follow up care. PROs are
        direct reports from patients about their health status. Compared with paper versions,
        electronic PROs (ePRO) allow patients to report their symptoms in real time outside of their
        clinic visit, facilitate direct data collection through the electronic health record, and
        enable clinicians to track symptoms long-term. The use of ePROs is associated with improved
        patient health outcomes, including better quality of life, reduced emergency department
        usage, and prolonged overall survival. The increased use of electronic communication
        technologies to capture PRO data long-term has been implemented through various methods
        including web-based, social media, text messages, mobile applications, and electronic
        portals. Text messaging is an accessible, though under-explored, communication channel for
        promoting ePRO collection. Information gathered from this study may help researchers
        understand MM patients' preferences for reporting symptoms via text message compared to a
        patient portal system.
  PRIMARY OBJECTIVES:
  
        I. To evaluate the patients' preference of TXT-Chatbot approach versus MyChart/Patient Portal
        approach, considering their demographic information.
  
        II. To evaluate each patient's adherence to the approach of his/her own choice by examining
        their utilization of the ePRO.
  
        SECONDARY OBJECTIVE:
  
        I. To examine the usability and satisfaction of the two implementation approaches of each
        patient's choice.
  
        EXPLORATORY OBJECTIVE:
  
        I. To explore and measure any differences in patients' preference of TXT-Chatbot approach
        versus MyChart/Patient Portal approach, as well as the number of completed of ePRO responses,
        in the course of 6 months, reported between race (African American versus [vs.] Caucasian)
        and approaches (Chatbot vs. MyChart/Patient Portal).
  
        OUTLINE: Patients are assigned to 1 of 2 groups.
  
        GROUP I: Patients receive a text message notification and complete surveys through
        TXT-Chatbot once every two weeks (Q2W) for 6 months.
  
        GROUP II: Patients receive an email notification and complete surveys through MyChart/Patient
        Portal Q2W for 6 months.
  
        After completion of study intervention, patients are followed up for 30 days.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Choice of TXT-Chatbot
  time frame: Up to 6 months
  description: The choice of implementation approaches will be summarized using percentages. Multivariable logistic regression analysis will be performed to explore the relationship between the choice of approaches and age, gender, etc.
  measure: Number of completed electronic Patient-Reported Outcome (ePRO) responses
  time frame: Up to 6 months
  description: The number of completed ePRO responses, over the course of 6 months, will be summarized using means and standard deviations, for the two implementation approaches. Multivariable Poisson regression analysis will be performed to explore the relationship between this endpoint and implementation approaches, age, gender, etc., with special consideration of the interaction between race (African American versus Caucasian) and implementation approaches.
  measure: Overall Satisfaction Scores Using the Client Satisfaction Questionnaire (CSQ-8)
  time frame: At 6 months
  description: Participants will complete the Client Satisfaction Questionnaire (CSQ-8), a validated measure that elicits the client's perspective on the value of services received. The 8 items are rated on a 1-5 scale with higher scores indicating greater satisfaction. The overall satisfaction score will be summarized using means and standard deviations across the 8 items. The dichotomized satisfaction score (overall score ≥ 3.5) will be summarized using percentages . Multivariable (non-)linear and logistic regression models will be performed to explore the relationship between the endpoints and implementation approaches, age, gender, and other measures.
  arm group label: Group I (TXT-Chatbot )
  arm group type: Experimental
  description: Patients receive a text message notification and complete surveys through TXT-Chatbot Q2W for 6 months.
  arm group label: Group II (MyChart/Patient Portal)
  arm group type: Experimental
  description: Patients receive an email notification and complete surveys through MyChart/Patient Portal Q2W for 6 weeks.
  intervention type: Other
  intervention name: Planned Notification
  description: Receive text notification
  arm group label: Group I (TXT-Chatbot )
  other name: PlannedNotification
  intervention type: Other
  intervention name: Survey Administration
  description: Complete surveys
  arm group label: Group I (TXT-Chatbot )
  intervention type: Behavioral
  intervention name: Behavioral Intervention
  description: Participate in TXT-Chatbot
  arm group label: Group I (TXT-Chatbot )
  other name: Behavior Conditioning Therapy
  other name: behavior modification
  other name: Behavior or Life Style Modifications
  other name: Behavior Therapy
  other name: Behavioral Interventions
  other name: Behavioral Modification
  other name: BEHAVIORAL THERAPY
  other name: Behavioral Treatment
  other name: Behavioral Treatments
  intervention type: Other
  intervention name: Electronic Health Record Review
  description: Ancillary studies
  arm group label: Group I (TXT-Chatbot )
  intervention type: Other
  intervention name: Interview
  description: Ancillary studies
  arm group label: Group I (TXT-Chatbot )
  intervention type: Other
  intervention name: Survey Administration
  description: Complete surveys
  arm group label: Group II (MyChart/Patient Portal)
  intervention type: Other
  intervention name: Planned Notification
  description: Receive email notification
  arm group label: Group II (MyChart/Patient Portal)
  other name: PlannedNotification
  intervention type: Behavioral
  intervention name: Behavioral Intervention
  description: Participate in MyChart/Patient Portal
  arm group label: Group II (MyChart/Patient Portal)
  other name: Behavior Conditioning Therapy
  other name: behavior modification
  other name: Behavior or Life Style Modifications
  other name: Behavior Therapy
  other name: Behavioral Interventions
  other name: Behavioral Modification
  other name: BEHAVIORAL THERAPY
  other name: Behavioral Treatment
  other name: Behavioral Treatments
  intervention type: Other
  intervention name: Electronic Health Record Review
  description: Ancillary studies
  arm group label: Group II (MyChart/Patient Portal)
  intervention type: Other
  intervention name: Interview
  description: Ancillary studies
  arm group label: Group II (MyChart/Patient Portal)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Kuang-Yi Wen, PhD
  phone: 215-503-4623
  email: Kuang-Yi.Wen@Jefferson.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Multiple Myeloma
  mesh term: Neoplasms, Plasma Cell