<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/NCT02970617</url>
  </required_header>
  <id_info>
    <org_study_id>OS-15-15</org_study_id>
    <secondary_id>NCI-2016-01259</secondary_id>
    <secondary_id>OS-15-15</secondary_id>
    <secondary_id>P30CA014089</secondary_id>
    <nct_id>NCT02970617</nct_id>
  </id_info>
  <brief_title>Ringing a Bell on the Final Day of Radiation Therapy in Improving the Memory of Distress in Cancer Patients</brief_title>
  <official_title>Are Last Impressions Lasting Impressions? Intervention of Ringing a Bell at the End of Cancer Treatment</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 clinical trial studies how well ringing a bell on the final day of radiation therapy&#xD;
      works in improving the memory of distress in cancer patients. Ringing a bell on the final day&#xD;
      of radiation therapy may improve the memory of how painful the treatment was.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To determine if the simple act of ringing a bell at the end of radiotherapy can improve&#xD;
      the retrospective evaluation of distress due to radiotherapy and other prior cancer therapy.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To measure the severity of patients' memory of distress from cancer treatment.&#xD;
&#xD;
      II. To assess the relationship between anxiety to actual distress and to remembered distress.&#xD;
&#xD;
      III. To assess the relationship between optimism-pessimism personality to actual distress and&#xD;
      to remembered distress.&#xD;
&#xD;
      IV. To assess patient's cognitive dissonance reduction to actual distress and to remembered&#xD;
      distress.&#xD;
&#xD;
      OUTLINE: Patients are assigned to 1 of 2 groups.&#xD;
&#xD;
      GROUP A (No bell ringing): Patients undergo standard of care radiation therapy with or&#xD;
      without chemotherapy.&#xD;
&#xD;
      GROUP B (Bell ringing): On the final day of standard of care radiation therapy, patients ring&#xD;
      a bell in the clinic.&#xD;
&#xD;
      After completion of study, patients are followed up for 7 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 15, 2016</start_date>
  <completion_date type="Actual">November 15, 2018</completion_date>
  <primary_completion_date type="Actual">November 15, 2018</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Distress memory scales as assessed by the 11-point Numeric Rating Scale</measure>
    <time_frame>Up to 7 months</time_frame>
    <description>Patient baseline characteristics and treatment will be summarized in groups A and B. Repeated measures analysis of variance (ANOVA) will be used to compare distress memory scales between patients in group A and group B. A mixed regression model will be used to examine the effect of ringing the bell on the last day of radiotherapy on distress memory scales when considering covariates such as baseline patient characteristics, cancer type, radiotherapy total dose and duration, baseline distress scale, analgesic medication, disease recurrence status, optimism/pessimism personality and anxiety.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anxiety level as assessed by Generalized Anxiety Disorder 7 scale</measure>
    <time_frame>Up to 7 months</time_frame>
    <description>Repeated measures ANOVA will be used to compare anxiety levels between patients in group A and group B. All p values will be two-sided at a significance level of 0.05.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optimism-pessimism scores as assessed by the Life Orientation Test-Revised</measure>
    <time_frame>Up to 7 months</time_frame>
    <description>Repeated measures ANOVA will be used to compare optimisim-pessimism scores between patients in group A and group B. All p values will be two-sided at a significance level of 0.05.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">82</enrollment>
  <condition>Distress</condition>
  <condition>Malignant Neoplasm</condition>
  <arm_group>
    <arm_group_label>Group A (no bell after final radiation)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients undergo standard of care radiation therapy with or without chemotherapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B (ring bell after final radiation treatment)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>On the final day of standard of care radiation therapy, patients ring a bell in the clinic.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Memory Intervention</intervention_name>
    <description>Ring bell after final radiation treatment</description>
    <arm_group_label>Group B (ring bell after final radiation treatment)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Group A (no bell after final radiation)</arm_group_label>
    <arm_group_label>Group B (ring bell after final radiation treatment)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiation therapy</intervention_name>
    <description>Radiation therapy with or without chemotherapy</description>
    <arm_group_label>Group A (no bell after final radiation)</arm_group_label>
    <arm_group_label>Group B (ring bell after final radiation treatment)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of cancer&#xD;
&#xD;
          -  Definitive radiation treatment with or without concurrent chemotherapy with curative&#xD;
             intent; treatment prior to radiation therapy is acceptable (e.g. surgery,&#xD;
             chemotherapy)&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent; consents&#xD;
             will be provided in English or Spanish&#xD;
&#xD;
          -  Able to speak English or Spanish (questionnaires will be in English and Spanish)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with either a malignant central nervous system (CNS)-primary cancer or with&#xD;
             brain metastases; patients do not need to undergo brain imaging unless indicated per&#xD;
             standard workup and management (e.g. advanced stage lung cancer receiving definitive&#xD;
             therapy)&#xD;
&#xD;
          -  Patients who will be receiving surgery or adjuvant chemotherapy within 1 month&#xD;
             following radiation treatment&#xD;
&#xD;
          -  Patients with widespread metastatic disease (&gt; 3 distant metastases); patients with&#xD;
             oligometastatic disease (=&lt; 3 distant metastases) are allowed only if they are&#xD;
             receiving definitive (curative) radiation therapy (RT) with or without chemotherapy&#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>April 2020</verification_date>
  <study_first_submitted>November 15, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <last_update_submitted>April 17, 2020</last_update_submitted>
  <last_update_submitted_qc>April 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 21, 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>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/NCT02970617
org study id: OS-15-15
secondary id: NCI-2016-01259
secondary id: OS-15-15
secondary id: P30CA014089
nct id: NCT02970617
lead sponsor: 
collaborator: 
has dmc: Yes
This clinical trial studies how well ringing a bell on the final day of radiation therapy
      works in improving the memory of distress in cancer patients. Ringing a bell on the final day
      of radiation therapy may improve the memory of how painful the treatment was.
PRIMARY OBJECTIVES:

      I. To determine if the simple act of ringing a bell at the end of radiotherapy can improve
      the retrospective evaluation of distress due to radiotherapy and other prior cancer therapy.

      SECONDARY OBJECTIVES:

      I. To measure the severity of patients' memory of distress from cancer treatment.

      II. To assess the relationship between anxiety to actual distress and to remembered distress.

      III. To assess the relationship between optimism-pessimism personality to actual distress and
      to remembered distress.

      IV. To assess patient's cognitive dissonance reduction to actual distress and to remembered
      distress.

      OUTLINE: Patients are assigned to 1 of 2 groups.

      GROUP A (No bell ringing): Patients undergo standard of care radiation therapy with or
      without chemotherapy.

      GROUP B (Bell ringing): On the final day of standard of care radiation therapy, patients ring
      a bell in the clinic.

      After completion of study, patients are followed up for 7 months.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Distress memory scales as assessed by the 11-point Numeric Rating Scale
time frame: Up to 7 months
description: Patient baseline characteristics and treatment will be summarized in groups A and B. Repeated measures analysis of variance (ANOVA) will be used to compare distress memory scales between patients in group A and group B. A mixed regression model will be used to examine the effect of ringing the bell on the last day of radiotherapy on distress memory scales when considering covariates such as baseline patient characteristics, cancer type, radiotherapy total dose and duration, baseline distress scale, analgesic medication, disease recurrence status, optimism/pessimism personality and anxiety.
measure: Anxiety level as assessed by Generalized Anxiety Disorder 7 scale
time frame: Up to 7 months
description: Repeated measures ANOVA will be used to compare anxiety levels between patients in group A and group B. All p values will be two-sided at a significance level of 0.05.
measure: Optimism-pessimism scores as assessed by the Life Orientation Test-Revised
time frame: Up to 7 months
description: Repeated measures ANOVA will be used to compare optimisim-pessimism scores between patients in group A and group B. All p values will be two-sided at a significance level of 0.05.
arm group label: Group A (no bell after final radiation)
arm group type: Active Comparator
description: Patients undergo standard of care radiation therapy with or without chemotherapy.
arm group label: Group B (ring bell after final radiation treatment)
arm group type: Experimental
description: On the final day of standard of care radiation therapy, patients ring a bell in the clinic.
intervention type: Other
intervention name: Memory Intervention
description: Ring bell after final radiation treatment
arm group label: Group B (ring bell after final radiation treatment)
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Group A (no bell after final radiation)
arm group label: Group B (ring bell after final radiation treatment)
intervention type: Radiation
intervention name: Radiation therapy
description: Radiation therapy with or without chemotherapy
arm group label: Group A (no bell after final radiation)
arm group label: Group B (ring bell after final radiation treatment)
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