<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/NCT03245411</url>
  </required_header>
  <id_info>
    <org_study_id>4950 EXP</org_study_id>
    <nct_id>NCT03245411</nct_id>
  </id_info>
  <brief_title>Assessment of Multi-Level Interventions to Improve Adherence to Oral Medications in Cancer Patients</brief_title>
  <official_title>A Randomized, Controlled Trial to Assess Multi-Level Interventions to Improve Adherence to Oral Medications in Cancer Patients in a Socioeconomically Disadvantaged Community</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Albert Einstein Healthcare Network</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Albert Einstein Healthcare Network</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Einstein Medical Center in Philadelphia serves a diverse group of the patient population. The&#xD;
      majority of patients have a diverse cultural background, low literacy, and poor&#xD;
      social-economic status. Medication adherence for chronic medical problems is in a range of&#xD;
      40-70%. Medication adherence among patients on oral anti-cancer therapy is not studied in&#xD;
      detail. The main objective is to study medication adherence to oral anticancer agents in&#xD;
      patients with low literacy and poor socio-economic status.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Until recently, contemporary approaches to cancer care have failed to consistently tailor&#xD;
      communication approaches to patients with low health literacy. They have produced mixed&#xD;
      results in regard to implementation of successful interventions in addressing the needs of&#xD;
      this populations. Low health literacy is especially common in medically underserved&#xD;
      communities, including in North Philadelphia. Cancer treatment, including cancer&#xD;
      chemotherapy, is complex, and it requires substantial skills, in order for patients to adhere&#xD;
      to care and achieve the goals of therapy. Patients with low health literacy find it&#xD;
      especially challenging to navigate cancer treatment. Results of previous research showed that&#xD;
      intervention strategies that address the needs for information and material support of&#xD;
      African American older adults, can help improve adherence to cancer screening in this&#xD;
      population.&#xD;
&#xD;
      The purpose is to develop and evaluate model interventions to improve healthcare outcomes for&#xD;
      socially disadvantaged populations. The objective in this proposal is to conduct a randomized&#xD;
      controlled trial that evaluates the effects of an intervention that provides enhanced&#xD;
      education and material support, on adherence to care, among the cancer patients of the&#xD;
      Medical Oncology Clinic of the Einstein Medical Center in Philadelphia.&#xD;
&#xD;
      The central hypothesis is that compared to the standard educational intervention delivered by&#xD;
      a registered nurse, the addition of an enhanced intervention (enhanced education,&#xD;
      problem-solving skills and facilitative support) will result in greater adherence care,&#xD;
      especially among patients with low health literacy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 20, 2017</start_date>
  <completion_date type="Anticipated">December 20, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 20, 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>Randomized Controlled Trial (RCT) Single Center</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adherence to oral chemotherapy</measure>
    <time_frame>6 months</time_frame>
    <description>Frequency of missed chemotherapy doses post randomization (based on interviews)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency of medication refills</measure>
    <time_frame>6 months</time_frame>
    <description>Prescription refills, based on pharmacy records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence to scheduled follow-up medical care visits</measure>
    <time_frame>6 months</time_frame>
    <description>Frequency and adherence to schedule follow up visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare utilization</measure>
    <time_frame>6 months</time_frame>
    <description>Any unscheduled visit (office Visit, ED Visits, Hospitalization, use of preventive care)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">110</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Standard of Care (Control Group)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>All participants in this group will receive the standard of care intervention provided by the RN.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In addition to the standard of care, the participants randomized to Intervention Group will be invited to a separate room. The following activities will be undertaken, in order to address patients' questions and concerns, and discuss potential solutions to their barriers to care&#xD;
The patient will be asked to watch brief educational videos on &quot;Life with oral cancer treatment.&quot; The information contained in the videos will be reinforced with materials written at a 4th grade level, that correspond to each of the brief videos.The patient will receive a brief phone call (from the study coordinator) on the first business day following the baseline interview, and thereafter, two weeks following each visit to the oncology clinic.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intervention</intervention_name>
    <description>All participants in this group will receive the standard of care intervention provided by the RN. This includes:Education in the clinic setting,Printed information about the chemotherapy drug and chemotherapy side effects. The RN will be blinded to the arm of study to which each patient is allocated.</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients on oral chemotherapeutic agents&#xD;
&#xD;
          -  Clinical diagnosis of stage IV breast cancer&#xD;
&#xD;
          -  Clinical diagnosis of stage III and IV colorectal cancer (not receiving concurrent&#xD;
             radiation therapy)&#xD;
&#xD;
          -  Clinical diagnosis of stage IV non-small cell lung cancer&#xD;
&#xD;
          -  Clinical diagnosis of stage IV renal cell carcinoma&#xD;
&#xD;
          -  Clinical diagnosis of stage IV ovarian carcinoma&#xD;
&#xD;
          -  Clinical diagnosis of multiple myeloma&#xD;
&#xD;
          -  Clinical diagnosis of chronic myelogenous leukemia on TKI&#xD;
&#xD;
          -  Clinical diagnosis of myelodysplastic syndrome on Lenalidomide&#xD;
&#xD;
          -  Adjuvant treatment for Gastro Intestinal Stromal Tumor&#xD;
&#xD;
          -  Clinical diagnosis of chronic Lymphocytic Leukemia&#xD;
&#xD;
          -  Clinical diagnosis of metastatic Prostate cancer&#xD;
&#xD;
          -  Clinical diagnosis of hepatocellular Carcinoma&#xD;
&#xD;
          -  Clinical diagnosis of stage IV Melanoma&#xD;
&#xD;
          -  Clinical diagnosis of myelofibrosis/myeloproliferative neoplasms&#xD;
&#xD;
          -  Age &gt;18 years&#xD;
&#xD;
          -  ECOG Performance Status &lt;3&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ECOG Performance Status of 3 and above&#xD;
&#xD;
          -  Concurrent chemo radiation&#xD;
&#xD;
          -  Non-English speaker&#xD;
&#xD;
          -  Clinical diagnosis of dementia, or otherwise unable to give informed consent.&#xD;
&#xD;
          -  History of non-compliance (defined as the history of 2 or more missed appointments in&#xD;
             the clinic).&#xD;
&#xD;
          -  Pregnant patients&#xD;
&#xD;
          -  Nursing Home Patients&#xD;
&#xD;
          -  Incarcerated&#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>Claudia M Dourado, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Albert Einstein Healthcare Network</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Claudia M Dourado, MD</last_name>
    <phone>215-456-3880</phone>
    <email>Douradoc@einstein.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Claudia Dourado</last_name>
    <phone>215-456-3880</phone>
    <email>Douradoc@einstein.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Albert Einstein Healthcare Network</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19141</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Claudia M Claudia M Dourado, MD</last_name>
      <phone>215-456-3880</phone>
      <email>DouradoC@einstein.edu</email>
    </contact>
    <contact_backup>
      <last_name>John C Leighton, MD</last_name>
      <phone>215-456-3880</phone>
      <email>leightoj@einstein.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>December 7, 2021</last_update_submitted>
  <last_update_submitted_qc>December 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Albert Einstein Healthcare Network</investigator_affiliation>
    <investigator_full_name>Claudia Dourado,MD</investigator_full_name>
    <investigator_title>Clinical Assistant Professor of Medicine</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/NCT03245411
org study id: 4950 EXP
nct id: NCT03245411
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Einstein Medical Center in Philadelphia serves a diverse group of the patient population. The
      majority of patients have a diverse cultural background, low literacy, and poor
      social-economic status. Medication adherence for chronic medical problems is in a range of
      40-70%. Medication adherence among patients on oral anti-cancer therapy is not studied in
      detail. The main objective is to study medication adherence to oral anticancer agents in
      patients with low literacy and poor socio-economic status.
Until recently, contemporary approaches to cancer care have failed to consistently tailor
      communication approaches to patients with low health literacy. They have produced mixed
      results in regard to implementation of successful interventions in addressing the needs of
      this populations. Low health literacy is especially common in medically underserved
      communities, including in North Philadelphia. Cancer treatment, including cancer
      chemotherapy, is complex, and it requires substantial skills, in order for patients to adhere
      to care and achieve the goals of therapy. Patients with low health literacy find it
      especially challenging to navigate cancer treatment. Results of previous research showed that
      intervention strategies that address the needs for information and material support of
      African American older adults, can help improve adherence to cancer screening in this
      population.

      The purpose is to develop and evaluate model interventions to improve healthcare outcomes for
      socially disadvantaged populations. The objective in this proposal is to conduct a randomized
      controlled trial that evaluates the effects of an intervention that provides enhanced
      education and material support, on adherence to care, among the cancer patients of the
      Medical Oncology Clinic of the Einstein Medical Center in Philadelphia.

      The central hypothesis is that compared to the standard educational intervention delivered by
      a registered nurse, the addition of an enhanced intervention (enhanced education,
      problem-solving skills and facilitative support) will result in greater adherence care,
      especially among patients with low health literacy.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized Controlled Trial (RCT) Single Center
primary purpose: Other
masking: None (Open Label)
measure: Adherence to oral chemotherapy
time frame: 6 months
description: Frequency of missed chemotherapy doses post randomization (based on interviews)
measure: Frequency of medication refills
time frame: 6 months
description: Prescription refills, based on pharmacy records
measure: Adherence to scheduled follow-up medical care visits
time frame: 6 months
description: Frequency and adherence to schedule follow up visit
measure: Healthcare utilization
time frame: 6 months
description: Any unscheduled visit (office Visit, ED Visits, Hospitalization, use of preventive care)
arm group label: Standard of Care (Control Group)
arm group type: No Intervention
description: All participants in this group will receive the standard of care intervention provided by the RN.
arm group label: Intervention Group
arm group type: Experimental
description: In addition to the standard of care, the participants randomized to Intervention Group will be invited to a separate room. The following activities will be undertaken, in order to address patients' questions and concerns, and discuss potential solutions to their barriers to care
The patient will be asked to watch brief educational videos on "Life with oral cancer treatment." The information contained in the videos will be reinforced with materials written at a 4th grade level, that correspond to each of the brief videos.The patient will receive a brief phone call (from the study coordinator) on the first business day following the baseline interview, and thereafter, two weeks following each visit to the oncology clinic.
intervention type: Behavioral
intervention name: Intervention
description: All participants in this group will receive the standard of care intervention provided by the RN. This includes:Education in the clinic setting,Printed information about the chemotherapy drug and chemotherapy side effects. The RN will be blinded to the arm of study to which each patient is allocated.
arm group label: Intervention Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Claudia M Dourado, MD
role: Principal Investigator
affiliation: Albert Einstein Healthcare Network
last name: Claudia M Dourado, MD
phone: 215-456-3880
email: Douradoc@einstein.edu
last name: Claudia Dourado
phone: 215-456-3880
email: Douradoc@einstein.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Albert Einstein Healthcare Network
investigator full name: Claudia Dourado,MD
investigator title: Clinical Assistant Professor of Medicine