<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/NCT02978846</url>
  </required_header>
  <id_info>
    <org_study_id>0S-15-17</org_study_id>
    <secondary_id>NCI-2016-01260</secondary_id>
    <secondary_id>0S-15-17</secondary_id>
    <secondary_id>P30CA014089</secondary_id>
    <nct_id>NCT02978846</nct_id>
  </id_info>
  <brief_title>Perceptions of Side Effects of Cancer Chemoradiotherapy</brief_title>
  <official_title>Patient Perceptions of Side Effects of Cancer Chemoradiotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Southern California</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is asking patients who are undergoing radiation therapy with or without&#xD;
      chemotherapy on how well they evaluate their side effects on the last day of treatment. This&#xD;
      study is not to change health outcomes of the patients in this study. Asking patients to rank&#xD;
      side effects in order of which ones bother them the most may help researchers identify the&#xD;
      most troubling side effects of cancer treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To examine the perceptions of side effects and their subjective severity of patients&#xD;
      treated with radiotherapy with and without concurrent chemotherapy at Los Angeles County&#xD;
      (LAC) + University of Southern California (USC) Medical Center.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To identify the most troubling side effects of patients treated with radiotherapy with and&#xD;
      without concurrent chemotherapy at LAC+USC Medical Center.&#xD;
&#xD;
      II. To evaluate the impact of chemotherapy combined with radiation therapy, in regards to&#xD;
      whether or not perceptions of side effects are altered by what cancer treatment is given.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients are shown two groups of cards on the last day of radiation treatment. Group A lists&#xD;
      48 physical side effects and group B lists 27 psychosocial side effects. The cards are&#xD;
      shuffled and patients view one card at a time and select the side effects they attribute to&#xD;
      their current treatment. Patients rank the selected cards from each group by order of&#xD;
      severity. The top 5 cards from each group are then shuffled together and patients rank the&#xD;
      remaining 10 cards in order of severity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2016</start_date>
  <completion_date type="Actual">August 14, 2018</completion_date>
  <primary_completion_date type="Actual">August 2, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Identify the most common type of side effects as perceived by patients on the last day of radiation treatment</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Tables and bar charts will be used to display the 10-20 highest ranked side effects overall, by sex and concurrent chemotherapy. Descriptive statistics such as means and standard deviation will be used.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">62</enrollment>
  <condition>Malignant Neoplasm</condition>
  <condition>Side Effect</condition>
  <arm_group>
    <arm_group_label>Observational (side effects evaluation using cards)</arm_group_label>
    <description>Patients are shown two groups of cards on the last day of radiation treatment. Group A lists 48 physical side effects and group B lists 27 psychosocial side effects. The cards are shuffled and patients view one card at a time and select the side effects they attribute to their current treatment. Patients rank the selected cards from each group by order of severity. The top 5 cards from each group are then shuffled together and patients rank the remaining 10 cards in order of severity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Clinical Observation</intervention_name>
    <description>Undergo side effects evaluation using cards</description>
    <arm_group_label>Observational (side effects evaluation using cards)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Cancer patients undergoing radiation therapy with or without chemotherapy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of cancer&#xD;
&#xD;
          -  Has received at least 4 consecutive weeks of definitive radiation treatment, with or&#xD;
             without concurrent chemotherapy&#xD;
&#xD;
          -  Has not received greater than 4 weeks of chemotherapy prior to radiation therapy start&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with either a central nervous system (CNS)-primary cancer or with brain&#xD;
             metastases&#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>Patrick Williams</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southern California</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>USC / Norris Comprehensive Cancer Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>November 15, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <last_update_submitted>October 3, 2018</last_update_submitted>
  <last_update_submitted_qc>October 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 2018</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>Neoplasms</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/NCT02978846
org study id: 0S-15-17
secondary id: NCI-2016-01260
secondary id: 0S-15-17
secondary id: P30CA014089
nct id: NCT02978846
lead sponsor: 
collaborator: 
has dmc: Yes
This study is asking patients who are undergoing radiation therapy with or without
      chemotherapy on how well they evaluate their side effects on the last day of treatment. This
      study is not to change health outcomes of the patients in this study. Asking patients to rank
      side effects in order of which ones bother them the most may help researchers identify the
      most troubling side effects of cancer treatment.
PRIMARY OBJECTIVES:

      I. To examine the perceptions of side effects and their subjective severity of patients
      treated with radiotherapy with and without concurrent chemotherapy at Los Angeles County
      (LAC) + University of Southern California (USC) Medical Center.

      SECONDARY OBJECTIVES:

      I. To identify the most troubling side effects of patients treated with radiotherapy with and
      without concurrent chemotherapy at LAC+USC Medical Center.

      II. To evaluate the impact of chemotherapy combined with radiation therapy, in regards to
      whether or not perceptions of side effects are altered by what cancer treatment is given.

      OUTLINE:

      Patients are shown two groups of cards on the last day of radiation treatment. Group A lists
      48 physical side effects and group B lists 27 psychosocial side effects. The cards are
      shuffled and patients view one card at a time and select the side effects they attribute to
      their current treatment. Patients rank the selected cards from each group by order of
      severity. The top 5 cards from each group are then shuffled together and patients rank the
      remaining 10 cards in order of severity.
observational model: Case-Only
time perspective: Prospective
measure: Identify the most common type of side effects as perceived by patients on the last day of radiation treatment
time frame: Up to 1 year
description: Tables and bar charts will be used to display the 10-20 highest ranked side effects overall, by sex and concurrent chemotherapy. Descriptive statistics such as means and standard deviation will be used.
arm group label: Observational (side effects evaluation using cards)
description: Patients are shown two groups of cards on the last day of radiation treatment. Group A lists 48 physical side effects and group B lists 27 psychosocial side effects. The cards are shuffled and patients view one card at a time and select the side effects they attribute to their current treatment. Patients rank the selected cards from each group by order of severity. The top 5 cards from each group are then shuffled together and patients rank the remaining 10 cards in order of severity.
intervention type: Other
intervention name: Clinical Observation
description: Undergo side effects evaluation using cards
arm group label: Observational (side effects evaluation using cards)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Patrick Williams
role: Principal Investigator
affiliation: University of Southern California
facility: 
country: United States
responsible party type: Sponsor
mesh term: Neoplasms