<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/NCT04406844</url>
  </required_header>
  <id_info>
    <org_study_id>Onco_Covid-19</org_study_id>
    <nct_id>NCT04406844</nct_id>
  </id_info>
  <brief_title>Issues and Challenges in Cancer Patients on Active Treatment During the COVID-19 Pandemic</brief_title>
  <official_title>An Observational Study to Identify the Issues and Challenges in Cancer Patients on Active Treatment During the COVID-19 Pandemic and the Resulting Lockdown</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Max Healthcare Insititute Limited</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Max Healthcare Insititute Limited</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>
      In view of increasing cases of SARS-CoV-2 leading to the COVID-19 Pandemic in India,there has&#xD;
      been unprecedented restrictions on travel, work and other aspects of daily life. Our study&#xD;
      has been designed to collect data of cancer patients to analyze their issues and challenges&#xD;
      during Covid-19 Pandemic.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Protocol No: Onco_Covid-19&#xD;
&#xD;
      Version no:1.0&#xD;
&#xD;
      Objectives: Firstly the patients recently diagnosed with cancer will be selected for&#xD;
      enrollment who are on active treatment during lockdown based on the date of their&#xD;
      registration in the hospital. This is followed by a telephonic interview with patients or&#xD;
      their attendant to carry out a prospective, cross-sectional, observational study in order to&#xD;
      address the issues and challenges faced by them during Lockdown.&#xD;
&#xD;
      Collection of data will be done through telephonic communication. Participation in this study&#xD;
      will be entirely voluntary. Telephonic verbal consent will be taken from the patients or&#xD;
      their attendants before collection of their response on the study questionnaire and then will&#xD;
      be asked questions accordingly based on the questionnaire which is available in English and&#xD;
      Hindi both. Data and general information regarding participants will only be collected in&#xD;
      questionnaire. No personal data of the participants will be taken which will also be conveyed&#xD;
      to the participant or attendant during telephonic verbal consent.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 9, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Oncology patients</measure>
    <time_frame>4-8 weeks</time_frame>
    <description>To focus on basic issues encountered by oncology patients such as transportation, medical facility, healthcare support, disease apprehension etc</description>
  </primary_outcome>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Oncology Patients</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will comprise all the cancer patients who are registered in the Max&#xD;
        Superspeciality hospital, Patparganj between Nov 1st 2019 to Jan 31st 2020&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Registered with the Max Institute of Cancer Care between Nov 1st 2019 to Jan 31st 2020&#xD;
&#xD;
          -  Were scheduled to receive one or more modalities of treatment (chemotherapy, surgery,&#xD;
             radiation therapy, immunotherapy) during the period Feb 1st 2020 to April 30th 2020&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>98 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Geeta Kadayaprath</last_name>
    <role>Principal Investigator</role>
    <affiliation>Max Hospital, Patparganj</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rajesh Saxena</last_name>
    <phone>9818474003</phone>
    <email>rajesh.saxena@maxhealthcare.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Max Superspeciality hospital, A Unit of Balaji Medical and Diagnostic Centre</name>
      <address>
        <city>New Delhi</city>
        <zip>110092</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rajesh Saxena</last_name>
      <phone>9818474003</phone>
      <email>rajesh.saxena@maxhealthcare.com</email>
    </contact>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>July 20, 2020</last_update_submitted>
  <last_update_submitted_qc>July 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2020</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>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>IPD sharing protocol is undecided at this stage. We may, however, provide the data if requested.</ipd_description>
  </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/NCT04406844
org study id: Onco_Covid-19
nct id: NCT04406844
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In view of increasing cases of SARS-CoV-2 leading to the COVID-19 Pandemic in India,there has
      been unprecedented restrictions on travel, work and other aspects of daily life. Our study
      has been designed to collect data of cancer patients to analyze their issues and challenges
      during Covid-19 Pandemic.
Protocol No: Onco_Covid-19

      Version no:1.0

      Objectives: Firstly the patients recently diagnosed with cancer will be selected for
      enrollment who are on active treatment during lockdown based on the date of their
      registration in the hospital. This is followed by a telephonic interview with patients or
      their attendant to carry out a prospective, cross-sectional, observational study in order to
      address the issues and challenges faced by them during Lockdown.

      Collection of data will be done through telephonic communication. Participation in this study
      will be entirely voluntary. Telephonic verbal consent will be taken from the patients or
      their attendants before collection of their response on the study questionnaire and then will
      be asked questions accordingly based on the questionnaire which is available in English and
      Hindi both. Data and general information regarding participants will only be collected in
      questionnaire. No personal data of the participants will be taken which will also be conveyed
      to the participant or attendant during telephonic verbal consent.
observational model: Cohort
time perspective: Cross-Sectional
measure: Oncology patients
time frame: 4-8 weeks
description: To focus on basic issues encountered by oncology patients such as transportation, medical facility, healthcare support, disease apprehension etc
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 12 Years
maximum age: 98 Years
healthy volunteers: No
last name: Geeta Kadayaprath
role: Principal Investigator
affiliation: Max Hospital, Patparganj
last name: Rajesh Saxena
phone: 9818474003
email: rajesh.saxena@maxhealthcare.com
facility: 
status: Recruiting
contact: 
country: India
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: Undecided
ipd description: IPD sharing protocol is undecided at this stage. We may, however, provide the data if requested.