<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/NCT03777306</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-300000121</org_study_id>
    <nct_id>NCT03777306</nct_id>
  </id_info>
  <brief_title>The Myeloma Pack: A Multi-Modality Educational Intervention Strategy to Engage Patients With Multiple Myeloma</brief_title>
  <official_title>The Myeloma Pack: A Multi-Modality Educational Intervention Strategy to Engage Patients With Multiple Myeloma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alabama at Birmingham</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>
      Multiple Myeloma (MM) patients are prone to poor quality of life (QoL) as a result of the&#xD;
      anxiety and depression they suffer due to a poor understanding of their disease. Improving&#xD;
      patient understanding of their illness and addressing issues that induce distress impacts&#xD;
      QoL. This prospective, interventional study is designed to see if a structured&#xD;
      psycho-educational program called &quot;the myeloma pack intervention&quot; (MPI), implemented in&#xD;
      parallel with standard cancer treatment, can improve QoL for patients with MM.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this research study is to see if the MPI educational program, implemented in&#xD;
      parallel with standard of care treatment, can improve overall quality of life (QoL) for MM&#xD;
      patients. This program will be delivered to the study participants by multiple modes of&#xD;
      communication including written material in a boxed pack, online tutorials, telephone and&#xD;
      text message follow up. If they do not have online access at home, the study coordinators&#xD;
      will arrange access for the participants at the Clinic. A health advisor will work with the&#xD;
      physicians to coordinate their participation in the program while they are on active&#xD;
      treatment for myeloma. The Pack Health Advisors will only give them guidance about the study&#xD;
      and they will not provide any kind of clinical advice to the participants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 27, 2017</start_date>
  <completion_date type="Anticipated">December 17, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 17, 2023</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>Sequential Assignment</intervention_model>
    <intervention_model_description>Multi-modality didactic education program implemented in parallel to standard cancer treatment to improve QoL for patients with MM</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assess baseline anxiety levels in MM patients undergoing therapy using the PROMIS assessment tool for anxiety</measure>
    <time_frame>Baseline</time_frame>
    <description>We will measure baseline anxiety levels in MM patients prior to implementation of educational program (MPI) using the PROMIS assessment tool for anxiety</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assess anxiety levels 12 weeks after educational program (MPI) in MM patients undergoing therapy using the PROMIS assessment tool for anxiety</measure>
    <time_frame>12 weeks post intervention</time_frame>
    <description>We will measure anxiety levels in MM patients 12 weeks after implementation of educational program (MPI) using the PROMIS assessment tool for anxiety</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assess anxiety levels 24 weeks after educational program (MPI) in MM patients undergoing therapy using the PROMIS assessment tool for anxiety</measure>
    <time_frame>24 weeks post intervention</time_frame>
    <description>We will measure anxiety levels in MM patients 24 weeks after implementation of educational program (MPI) using the PROMIS assessment tool for anxiety</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assess baseline depression levels in MM patients using the PROMIS assessment tool for depression</measure>
    <time_frame>Baseline</time_frame>
    <description>We will measure baseline depression in MM patients prior to implementation of educational program using the PROMIS assessment tool for depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess depression levels 12 weeks after education intervention (MPI) in MM patients using the PROMIS assessment tool for depression</measure>
    <time_frame>12 weeks post intervention</time_frame>
    <description>We will assess outcomes 12 weeks after implementation of educational program using the PROMIS assessment tool for depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess depression levels 24 weeks after education intervention (MPI) in MM patients using the PROMIS assessment tool for depression</measure>
    <time_frame>24 weeks post intervention</time_frame>
    <description>We will assess outcomes 24 weeks after implementation of educational program using the PROMIS assessment tool for depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess baseline patient self-efficacy for symptom management in MM patients using the PROMIS assessment tool for self-Efficacy</measure>
    <time_frame>Baseline</time_frame>
    <description>We will assess baseline patient self-efficacy for symptom management in MM patients before the implementation of educational program (MPI) using the PROMIS assessment tool for self-Efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess patient self-efficacy for symptom management 12 weeks after educational program (MPI) in MM patients using the PROMIS assessment tool for self-Efficacy</measure>
    <time_frame>12 weeks post intervention</time_frame>
    <description>We will assess outcomes 12 weeks after implementation of educational program (MPI) using the PROMIS assessment tool for self-Efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess patient self-efficacy for symptom management 24 weeks after educational program (MPI) in MM patients using the PROMIS assessment tool for self-Efficacy</measure>
    <time_frame>24 weeks post intervention</time_frame>
    <description>We will assess outcomes 24 weeks after implementation of educational program (MPI) using the PROMIS assessment tool for self-Efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess baseline patient adherence to myeloma specific medication and treatment schedules in MM patients using the CASE Medication Adherence Index</measure>
    <time_frame>Baseline</time_frame>
    <description>We will baseline assess patient adherence to myeloma specific medication and treatment schedules in MM patients before the implementation of educational program (MPI) using the CASE Medication Adherence Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess patient improvement in adherence to myeloma specific medication and treatment schedules 12 weeks after educational program (MPI) in MM patients using the CASE Medication Adherence Index</measure>
    <time_frame>12 weeks post intervention</time_frame>
    <description>We will assess outcomes 12 weeks after implementation of educational program (MPI) using the CASE Medication Adherence Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess patient improvement in adherence to myeloma specific medication and treatment schedules 24 weeks after educational program (MPI) in MM patients using the CASE Medication Adherence Index</measure>
    <time_frame>24 weeks post intervention</time_frame>
    <description>We will assess outcomes 24 weeks after implementation of educational program (MPI) using the CASE Medication Adherence Index</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Assess baseline Qualityof Life (QoL) in MM patients undergoing therapy using EORTC-QLQ-C30, and FACIT-sp-12 questionnaires</measure>
    <time_frame>Baseline</time_frame>
    <description>We will baseline QoL in MM patients before implementation of educational program (MPI) using EORTC-QLQ-C30, and FACIT-sp-12 questionnaires</description>
  </other_outcome>
  <other_outcome>
    <measure>Assess effect on Qualityof Life (QoL) 12 weeks after educational program (MPI) in MM patients undergoing therapy using EORTC-QLQ-C30, and FACIT-sp-12 questionnaires</measure>
    <time_frame>12 weeks post intervention</time_frame>
    <description>We will assess outcomes 12 weeks after implementation of educational program (MPI) using EORTC-QLQ-C30, and FACIT-sp-12 questionnaires</description>
  </other_outcome>
  <other_outcome>
    <measure>Assess effect on Qualityof Life (QoL) 24 weeks after educational program (MPI) in MM patients undergoing therapy using EORTC-QLQ-C30, and FACIT-sp-12 questionnaires</measure>
    <time_frame>24 weeks post intervention</time_frame>
    <description>We will assess outcomes 24 weeks after implementation of educational program (MPI) using EORTC-QLQ-C30, and FACIT-sp-12 questionnaires</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Multiple Myeloma</condition>
  <arm_group>
    <arm_group_label>ARM A EARLY INTERVENTION GROUP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In Arm A, the intervention group, the participants will start on the program immediately. The participants will receive MPI educational program, implemented in parallel with standard of care treatment. The MPI is implemented at the time of enrollment x 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ARM B DELAYED INTERVENTION GROUP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arm B, is a wait-list control group that will serve as the control. The wait-list control group will be observed for an initial 12 week period while receiving usual care and then have the educational intervention implemented from week 12-24 in parallel with standard of care</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ARM A EARLY INTERVENTION GROUP</intervention_name>
    <description>Post randomization, all patients will take baseline survey to assess their level of stress prior to starting the educational program During the educational interventions they will receive&#xD;
1 video/picture/worksheet per week covering the topic to be covered.&#xD;
1 phone/week by the Health Advisor, to discuss the topic for the week s/as their disease, stress and anxiety management, life organization, adherence skills, healthy eating and sleeping). Participant and the health advisor will also set up a &quot;Tiny Step&quot;&quot; to serve as a goal for the week .&#xD;
3 emails/texts through the week, to remind about the topic covered, or to encourage them on their Tiny Step goal.&#xD;
After 12 weeks on the program participants will re-take the surveys to assess the level of stress.</description>
    <arm_group_label>ARM A EARLY INTERVENTION GROUP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ARM B DELAYED INTERVENTION GROUP</intervention_name>
    <description>The educational intervention is similar as in ARM A except that the participants will receive standard of care for the first 12 weeks post randomization and then begin the educational intervention</description>
    <arm_group_label>ARM B DELAYED INTERVENTION GROUP</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Of age ≥18 years or older.&#xD;
&#xD;
          -  Having a diagnosis of MM; newly diagnosed or relapsed/refractory disease&#xD;
&#xD;
          -  Undergoing systemic treatment through the UAB MM Clinic Pathway&#xD;
&#xD;
          -  Able to provide informed consent to be included in the intervention&#xD;
&#xD;
          -  MM patients in a prior/concurrent (non-pyscho/educational intervention), MM study will&#xD;
             be eligible to participate&#xD;
&#xD;
          -  Have either SMS texting or email access to receive encouragement messages&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients will be ineligible for the program if they are:&#xD;
&#xD;
          -  Being treated by end-of-life or comfort care measures only&#xD;
&#xD;
          -  MM patients not treated through the UAB MM Clinic Pathway.&#xD;
&#xD;
          -  MM patients not requiring systemic therapy.&#xD;
&#xD;
          -  Patients with a diagnosis of MGUS or SMM.&#xD;
&#xD;
          -  Have a history of other malignancy within the past [3 or 5] years with the exception&#xD;
             of:&#xD;
&#xD;
          -  Malignancies treated with curative intent and with no known active disease present for&#xD;
             ≥ 3 (or 5) years before enrollment and felt to be at low risk for recurrence by the&#xD;
             treating physician&#xD;
&#xD;
          -  Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of&#xD;
             disease&#xD;
&#xD;
          -  Adequately treated cervical carcinoma in situ without evidence of disease&#xD;
&#xD;
          -  Adequately treated breast ductal carcinoma in situ without evidence of disease&#xD;
&#xD;
          -  Prostatic intraepithelial neoplasia without evidence of prostate cancer&#xD;
&#xD;
          -  Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ&#xD;
&#xD;
          -  Are enrolled in a prior/concurrent MM psycho-educational study&#xD;
&#xD;
        Other Exclusions:&#xD;
&#xD;
          -  Patients who do not have either SMS texting or email access to receive encouragement&#xD;
             messaging will be excluded&#xD;
&#xD;
          -  History or evidence of any other clinically significant disorder, condition or disease&#xD;
             (with the exception of those outlined above) that, in the opinion of the investigator&#xD;
             or Amgen physician, if consulted, would pose a risk to subject safety or interfere&#xD;
             with the study evaluation, procedures or completion.&#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>Smith Giri, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alabama at Birmingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>September 27, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>November 29, 2022</last_update_submitted>
  <last_update_submitted_qc>November 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Smith Giri</investigator_full_name>
    <investigator_title>PI</investigator_title>
  </responsible_party>
  <keyword>Educational intervention</keyword>
  <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>


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/NCT03777306
org study id: IRB-300000121
nct id: NCT03777306
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Multiple Myeloma (MM) patients are prone to poor quality of life (QoL) as a result of the
      anxiety and depression they suffer due to a poor understanding of their disease. Improving
      patient understanding of their illness and addressing issues that induce distress impacts
      QoL. This prospective, interventional study is designed to see if a structured
      psycho-educational program called "the myeloma pack intervention" (MPI), implemented in
      parallel with standard cancer treatment, can improve QoL for patients with MM.
The purpose of this research study is to see if the MPI educational program, implemented in
      parallel with standard of care treatment, can improve overall quality of life (QoL) for MM
      patients. This program will be delivered to the study participants by multiple modes of
      communication including written material in a boxed pack, online tutorials, telephone and
      text message follow up. If they do not have online access at home, the study coordinators
      will arrange access for the participants at the Clinic. A health advisor will work with the
      physicians to coordinate their participation in the program while they are on active
      treatment for myeloma. The Pack Health Advisors will only give them guidance about the study
      and they will not provide any kind of clinical advice to the participants.
allocation: Randomized
intervention model: Sequential Assignment
intervention model description: Multi-modality didactic education program implemented in parallel to standard cancer treatment to improve QoL for patients with MM
primary purpose: Supportive Care
masking: None (Open Label)
measure: Assess baseline anxiety levels in MM patients undergoing therapy using the PROMIS assessment tool for anxiety
time frame: Baseline
description: We will measure baseline anxiety levels in MM patients prior to implementation of educational program (MPI) using the PROMIS assessment tool for anxiety
measure: Assess anxiety levels 12 weeks after educational program (MPI) in MM patients undergoing therapy using the PROMIS assessment tool for anxiety
time frame: 12 weeks post intervention
description: We will measure anxiety levels in MM patients 12 weeks after implementation of educational program (MPI) using the PROMIS assessment tool for anxiety
measure: Assess anxiety levels 24 weeks after educational program (MPI) in MM patients undergoing therapy using the PROMIS assessment tool for anxiety
time frame: 24 weeks post intervention
description: We will measure anxiety levels in MM patients 24 weeks after implementation of educational program (MPI) using the PROMIS assessment tool for anxiety
measure: Assess baseline depression levels in MM patients using the PROMIS assessment tool for depression
time frame: Baseline
description: We will measure baseline depression in MM patients prior to implementation of educational program using the PROMIS assessment tool for depression
measure: Assess depression levels 12 weeks after education intervention (MPI) in MM patients using the PROMIS assessment tool for depression
time frame: 12 weeks post intervention
description: We will assess outcomes 12 weeks after implementation of educational program using the PROMIS assessment tool for depression
measure: Assess depression levels 24 weeks after education intervention (MPI) in MM patients using the PROMIS assessment tool for depression
time frame: 24 weeks post intervention
description: We will assess outcomes 24 weeks after implementation of educational program using the PROMIS assessment tool for depression
measure: Assess baseline patient self-efficacy for symptom management in MM patients using the PROMIS assessment tool for self-Efficacy
time frame: Baseline
description: We will assess baseline patient self-efficacy for symptom management in MM patients before the implementation of educational program (MPI) using the PROMIS assessment tool for self-Efficacy
measure: Assess patient self-efficacy for symptom management 12 weeks after educational program (MPI) in MM patients using the PROMIS assessment tool for self-Efficacy
time frame: 12 weeks post intervention
description: We will assess outcomes 12 weeks after implementation of educational program (MPI) using the PROMIS assessment tool for self-Efficacy
measure: Assess patient self-efficacy for symptom management 24 weeks after educational program (MPI) in MM patients using the PROMIS assessment tool for self-Efficacy
time frame: 24 weeks post intervention
description: We will assess outcomes 24 weeks after implementation of educational program (MPI) using the PROMIS assessment tool for self-Efficacy
measure: Assess baseline patient adherence to myeloma specific medication and treatment schedules in MM patients using the CASE Medication Adherence Index
time frame: Baseline
description: We will baseline assess patient adherence to myeloma specific medication and treatment schedules in MM patients before the implementation of educational program (MPI) using the CASE Medication Adherence Index
measure: Assess patient improvement in adherence to myeloma specific medication and treatment schedules 12 weeks after educational program (MPI) in MM patients using the CASE Medication Adherence Index
time frame: 12 weeks post intervention
description: We will assess outcomes 12 weeks after implementation of educational program (MPI) using the CASE Medication Adherence Index
measure: Assess patient improvement in adherence to myeloma specific medication and treatment schedules 24 weeks after educational program (MPI) in MM patients using the CASE Medication Adherence Index
time frame: 24 weeks post intervention
description: We will assess outcomes 24 weeks after implementation of educational program (MPI) using the CASE Medication Adherence Index
measure: Assess baseline Qualityof Life (QoL) in MM patients undergoing therapy using EORTC-QLQ-C30, and FACIT-sp-12 questionnaires
time frame: Baseline
description: We will baseline QoL in MM patients before implementation of educational program (MPI) using EORTC-QLQ-C30, and FACIT-sp-12 questionnaires
measure: Assess effect on Qualityof Life (QoL) 12 weeks after educational program (MPI) in MM patients undergoing therapy using EORTC-QLQ-C30, and FACIT-sp-12 questionnaires
time frame: 12 weeks post intervention
description: We will assess outcomes 12 weeks after implementation of educational program (MPI) using EORTC-QLQ-C30, and FACIT-sp-12 questionnaires
measure: Assess effect on Qualityof Life (QoL) 24 weeks after educational program (MPI) in MM patients undergoing therapy using EORTC-QLQ-C30, and FACIT-sp-12 questionnaires
time frame: 24 weeks post intervention
description: We will assess outcomes 24 weeks after implementation of educational program (MPI) using EORTC-QLQ-C30, and FACIT-sp-12 questionnaires
arm group label: ARM A EARLY INTERVENTION GROUP
arm group type: Experimental
description: In Arm A, the intervention group, the participants will start on the program immediately. The participants will receive MPI educational program, implemented in parallel with standard of care treatment. The MPI is implemented at the time of enrollment x 12 weeks
arm group label: ARM B DELAYED INTERVENTION GROUP
arm group type: Experimental
description: Arm B, is a wait-list control group that will serve as the control. The wait-list control group will be observed for an initial 12 week period while receiving usual care and then have the educational intervention implemented from week 12-24 in parallel with standard of care
intervention type: Other
intervention name: ARM A EARLY INTERVENTION GROUP
description: Post randomization, all patients will take baseline survey to assess their level of stress prior to starting the educational program During the educational interventions they will receive
1 video/picture/worksheet per week covering the topic to be covered.
1 phone/week by the Health Advisor, to discuss the topic for the week s/as their disease, stress and anxiety management, life organization, adherence skills, healthy eating and sleeping). Participant and the health advisor will also set up a "Tiny Step"" to serve as a goal for the week .
3 emails/texts through the week, to remind about the topic covered, or to encourage them on their Tiny Step goal.
After 12 weeks on the program participants will re-take the surveys to assess the level of stress.
arm group label: ARM A EARLY INTERVENTION GROUP
intervention type: Other
intervention name: ARM B DELAYED INTERVENTION GROUP
description: The educational intervention is similar as in ARM A except that the participants will receive standard of care for the first 12 weeks post randomization and then begin the educational intervention
arm group label: ARM B DELAYED INTERVENTION GROUP
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Smith Giri, MD
role: Principal Investigator
affiliation: University of Alabama at Birmingham
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Smith Giri
investigator title: PI
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell