<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/NCT02197091</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00028889</org_study_id>
    <secondary_id>NCI-2014-01478</secondary_id>
    <secondary_id>IRB00028889</secondary_id>
    <secondary_id>CCCWFU #99514</secondary_id>
    <secondary_id>P30CA012197</secondary_id>
    <nct_id>NCT02197091</nct_id>
  </id_info>
  <brief_title>Communication Effectiveness in Cancer Treatment</brief_title>
  <official_title>A Health Services Research Study to Evaluate Communication Effectiveness in Oncology Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Wake Forest University Health Sciences</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>
      This pilot research trial studies communication effectiveness in cancer treatment. Studying&#xD;
      how well patients and their doctors communicate about the treatment being given for cancer&#xD;
      may help improve the decisions that patients and physicians make together.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To assess the feasibility of measuring discrepancies between patient and physician&#xD;
      perceptions about the intent of therapy.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To explore possible correlation between various patient satisfaction indicators and&#xD;
      discrepant patient perceptions about their care.&#xD;
&#xD;
      II. To gather exploratory data on patient characteristics that might correlate with&#xD;
      discrepant patient perceptions about their care.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients complete questionnaires, including the Functional Assessment of Cancer&#xD;
      Therapy-Treatment Satisfaction (FACIT-TS-G), the Functional Assessment of Cancer&#xD;
      Therapy-Spiritual Well Being (FACIT-Sp12), the Medical Outcomes Study Social Support Survey&#xD;
      (MOS-SSS), and the Distress Thermometer (DT). Doctors also complete a questionnaire.&#xD;
      Patients' medical records may be reviewed, if necessary.&#xD;
&#xD;
      After completion of study, patients are followed up for 5 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2014</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</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>Patient perceptions about the nature of their therapy and diagnosis</measure>
    <time_frame>Baseline</time_frame>
    <description>The precision of agreement between patient's and doctor's responses about the intent of therapy will be assessed. The level of agreement between the questions as answered by the patient on the Prognosis Instrument and by the doctor on the Doctor Questionnaire will be assessed. Agreement will be measured as either &quot;yes&quot; (meaning the doctor and patient responses match exactly) or &quot;no&quot; (any other combination, if both doctor and patient responded). The primary measure of agreement will be the Kappa statistic; the Kappa and its corresponding 95% confidence interval (CI) will be reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility, as assessed by accrual rate</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Accrual will be estimated as the number of patients accrued divided by the months of accrual. A 95% confidence interval for the monthly accrual will be calculated based on the Poisson distribution.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility, as assessed by participation rate</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>The participation rate will be estimated as the number of patients who are participants divided by the number eligible. This estimate will be calculated separately by cancer type to see what cancer types are more or less likely to participate. An exact 95% CI will be calculated for this estimate of each cancer type.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of discrepancies between patient perceptions and the clinical record</measure>
    <time_frame>Baseline</time_frame>
    <description>The FACIT-TS-G, FACIT-Sp12, MOS-SSS, and DT instruments will be used to see if there might be a relationship between the observed scores and discrepancies in the answers provided by patients and the clinical record. Patient characteristics will be assessed for differences between the two records. Means, standard deviations, and medians will be calculated for each of the scores, stratified by discrepancy type for those who do not match and those who match perfectly. These data will be analyzed by analysis of variance.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Malignant Neoplasm</condition>
  <arm_group>
    <arm_group_label>Observational (communication in oncology treatment)</arm_group_label>
    <description>Patients complete questionnaires, including the FACIT-TS-G, the FACIT-Sp12, the MOS-SSS, and the DT. Doctors also complete a questionnaire. Patients' medical records may be reviewed, if necessary.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>questionnaire administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Observational (communication in oncology treatment)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>medical chart review</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Observational (communication in oncology treatment)</arm_group_label>
    <other_name>chart review</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adults receiving cancer treatment&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with a diagnosis of cancer&#xD;
&#xD;
          -  Patients must have been in active therapy for cancer for at least one month or have a&#xD;
             scheduled surgical treatment of their cancer&#xD;
&#xD;
          -  Ability to understand and the willingness to sign an institutional review board&#xD;
             (IRB)-approved informed consent document&#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>Katharine Duckworth, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Comprehensive Cancer Center of Wake Forest University</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>July 21, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>July 2, 2018</last_update_submitted>
  <last_update_submitted_qc>July 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 3, 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/NCT02197091
org study id: IRB00028889
secondary id: NCI-2014-01478
secondary id: IRB00028889
secondary id: CCCWFU #99514
secondary id: P30CA012197
nct id: NCT02197091
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This pilot research trial studies communication effectiveness in cancer treatment. Studying
      how well patients and their doctors communicate about the treatment being given for cancer
      may help improve the decisions that patients and physicians make together.
PRIMARY OBJECTIVES:

      I. To assess the feasibility of measuring discrepancies between patient and physician
      perceptions about the intent of therapy.

      SECONDARY OBJECTIVES:

      I. To explore possible correlation between various patient satisfaction indicators and
      discrepant patient perceptions about their care.

      II. To gather exploratory data on patient characteristics that might correlate with
      discrepant patient perceptions about their care.

      OUTLINE:

      Patients complete questionnaires, including the Functional Assessment of Cancer
      Therapy-Treatment Satisfaction (FACIT-TS-G), the Functional Assessment of Cancer
      Therapy-Spiritual Well Being (FACIT-Sp12), the Medical Outcomes Study Social Support Survey
      (MOS-SSS), and the Distress Thermometer (DT). Doctors also complete a questionnaire.
      Patients' medical records may be reviewed, if necessary.

      After completion of study, patients are followed up for 5 years.
observational model: Case-Only
time perspective: Prospective
measure: Patient perceptions about the nature of their therapy and diagnosis
time frame: Baseline
description: The precision of agreement between patient's and doctor's responses about the intent of therapy will be assessed. The level of agreement between the questions as answered by the patient on the Prognosis Instrument and by the doctor on the Doctor Questionnaire will be assessed. Agreement will be measured as either "yes" (meaning the doctor and patient responses match exactly) or "no" (any other combination, if both doctor and patient responded). The primary measure of agreement will be the Kappa statistic; the Kappa and its corresponding 95% confidence interval (CI) will be reported.
measure: Feasibility, as assessed by accrual rate
time frame: Up to 5 years
description: Accrual will be estimated as the number of patients accrued divided by the months of accrual. A 95% confidence interval for the monthly accrual will be calculated based on the Poisson distribution.
measure: Feasibility, as assessed by participation rate
time frame: Up to 5 years
description: The participation rate will be estimated as the number of patients who are participants divided by the number eligible. This estimate will be calculated separately by cancer type to see what cancer types are more or less likely to participate. An exact 95% CI will be calculated for this estimate of each cancer type.
measure: Incidence of discrepancies between patient perceptions and the clinical record
time frame: Baseline
description: The FACIT-TS-G, FACIT-Sp12, MOS-SSS, and DT instruments will be used to see if there might be a relationship between the observed scores and discrepancies in the answers provided by patients and the clinical record. Patient characteristics will be assessed for differences between the two records. Means, standard deviations, and medians will be calculated for each of the scores, stratified by discrepancy type for those who do not match and those who match perfectly. These data will be analyzed by analysis of variance.
arm group label: Observational (communication in oncology treatment)
description: Patients complete questionnaires, including the FACIT-TS-G, the FACIT-Sp12, the MOS-SSS, and the DT. Doctors also complete a questionnaire. Patients' medical records may be reviewed, if necessary.
intervention type: Other
intervention name: questionnaire administration
description: Ancillary studies
arm group label: Observational (communication in oncology treatment)
intervention type: Other
intervention name: medical chart review
description: Ancillary studies
arm group label: Observational (communication in oncology treatment)
other name: chart review
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Katharine Duckworth, PhD
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
facility: 
country: United States
responsible party type: Sponsor
mesh term: Neoplasms