<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/NCT02217891</url>
  </required_header>
  <id_info>
    <org_study_id>14-159</org_study_id>
    <nct_id>NCT02217891</nct_id>
  </id_info>
  <brief_title>IFACT: Incidental Findings in Advanced Cancer Therapy</brief_title>
  <acronym>IFACT</acronym>
  <official_title>IFACT: Incidental Findings in Advanced Cancer Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Memorial Sloan Kettering Cancer Center</source>
  <brief_summary>
    <textblock>
      The proposed study, IFACT - Incidental Findings in Advanced Cancer Therapy, will address this&#xD;
      research gap by examining MSK patients' attitudes, preferences, and information needs&#xD;
      regarding incidental findings arising from tumor genomic profiling.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Part 1, the investigators will recruit 40 participants from those already enrolled in&#xD;
      existing MSK IRB protocol #12-245 (PI: David Hyman, MD) including male and female patients&#xD;
      who have been diagnosed with late-stage breast, colorectal, bladder, and lung cancer (some of&#xD;
      the most common cancers in this study population).&#xD;
&#xD;
      Part 2, the investigators will recruit 20 participants from those who have actually received&#xD;
      incidental germline findings from MSK IRB protocol #12-245 Consent Part C in order to&#xD;
      cognitively test novel survey items about their knowledge and perceived utility of their&#xD;
      incidental findings (note that the content of these items will be derived from the data&#xD;
      collected in Part 1)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">February 9, 2023</completion_date>
  <primary_completion_date type="Actual">February 9, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>qualitive data</measure>
    <time_frame>one time</time_frame>
    <description>The study team will review and code the interview transcripts through a process of independent and collaborative thematic content analysis,(25-28) using ATLAS.ti (a qualitative data analysis software package) to facilitate the analysis process (29).</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Colorectal Cancer</condition>
  <condition>Bladder Cancer</condition>
  <condition>Lung Cancer</condition>
  <arm_group>
    <arm_group_label>participants from existing MSK protocol 12-245</arm_group_label>
    <description>Participants' responses regarding the benefits and harms of incidental findings arising from tumor genomic profiling will be used to generate novel questionnaire items to assess the construct of perceived personal and clinical utility, which will be tested, along with items designed to assess knowledge about tumor genomic profiling and incidental findings.&#xD;
Part 2, the investigators will conduct 30-minute cognitive interviews to assess participants' understanding and opinions about the novel items designed to assess perceived personal and clinical utility of incidental findings and knowledge about incidental findings arising from tumor genomic profiling.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Semi-structured interview</intervention_name>
    <description>Pts will participate in a 45-60-minute, one-on-one, audio-recorded interview. They will be conducted over the telephone or in person at the MSK Counseling Center. They will be conducted in accordance with a semi-structured interview guide developed by our study team of experts in clinical genetics, health psychology, &amp; qualitative methodology. Topics to be covered in the interview include: 1) perceived potential benefits &amp; harms of tumor genomic profiling; 2) interest in &amp; perceived benefits &amp; harms of incidental findings arising from tumor genomic profiling; 3) anticipated process &amp; needs for decision-making about learning incidental findings; 4) interest in learning specific kinds of incidental findings (including those related to treatable diseases, different cancers, non-treatable diseases, &amp; those that only have meaning for family members); 5) preferences about sharing incidental findings with other people; &amp; 6) implications of &amp; concerns about incidental findings for family.</description>
    <arm_group_label>participants from existing MSK protocol 12-245</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        IFACT study participants will be recruited from existing MSK protocol #12-245.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Part 1:&#xD;
&#xD;
          -  Patient enrolled on MSK protocol #12-245&#xD;
&#xD;
          -  Living patient age 18 or older&#xD;
&#xD;
          -  Patient diagnosed with breast cancer, colorectal cancer, bladder cancer, or lung&#xD;
             cancer&#xD;
&#xD;
          -  Patient residing in New York metro-area&#xD;
&#xD;
        Part 2:&#xD;
&#xD;
          -  Living patient age 18 or older&#xD;
&#xD;
          -  Consented to Part C of IRB#12-245 and has received results regardless if thereir was a&#xD;
             pathogenic variant&#xD;
&#xD;
          -  Patient diagnosed with cancer type approved for IRB#12-245 Part C (which are currently&#xD;
             breast cancer, gynecological cancer, prostate cancer, and GU non-prostate&#xD;
             cancer)breast cancer, colorectal cancer, bladder cancer, or lung cancer&#xD;
&#xD;
          -  Patient residing in New York metro-area&#xD;
&#xD;
        Exclusion Criteria for Part 1 and 2:&#xD;
&#xD;
          -  Non-English speakers because we do not have the resources to conduct and translate the&#xD;
             interviews into other languages.&#xD;
&#xD;
          -  Patient unwilling or unable to provide informed consent.&#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>Jada Hamilton, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mskcc.org/</url>
    <description>Memorial Sloan Kettering Cancer Center</description>
  </link>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>August 13, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>February 10, 2023</last_update_submitted>
  <last_update_submitted_qc>February 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 13, 2023</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>Colorectal Neoplasms</mesh_term>
    <mesh_term>Urinary Bladder 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/NCT02217891
org study id: 14-159
nct id: NCT02217891
lead sponsor: 
The proposed study, IFACT - Incidental Findings in Advanced Cancer Therapy, will address this
      research gap by examining MSK patients' attitudes, preferences, and information needs
      regarding incidental findings arising from tumor genomic profiling.
Part 1, the investigators will recruit 40 participants from those already enrolled in
      existing MSK IRB protocol #12-245 (PI: David Hyman, MD) including male and female patients
      who have been diagnosed with late-stage breast, colorectal, bladder, and lung cancer (some of
      the most common cancers in this study population).

      Part 2, the investigators will recruit 20 participants from those who have actually received
      incidental germline findings from MSK IRB protocol #12-245 Consent Part C in order to
      cognitively test novel survey items about their knowledge and perceived utility of their
      incidental findings (note that the content of these items will be derived from the data
      collected in Part 1)
observational model: Case-Crossover
time perspective: Prospective
measure: qualitive data
time frame: one time
description: The study team will review and code the interview transcripts through a process of independent and collaborative thematic content analysis,(25-28) using ATLAS.ti (a qualitative data analysis software package) to facilitate the analysis process (29).
arm group label: participants from existing MSK protocol 12-245
description: Participants' responses regarding the benefits and harms of incidental findings arising from tumor genomic profiling will be used to generate novel questionnaire items to assess the construct of perceived personal and clinical utility, which will be tested, along with items designed to assess knowledge about tumor genomic profiling and incidental findings.
Part 2, the investigators will conduct 30-minute cognitive interviews to assess participants' understanding and opinions about the novel items designed to assess perceived personal and clinical utility of incidental findings and knowledge about incidental findings arising from tumor genomic profiling.
intervention type: Behavioral
intervention name: Semi-structured interview
description: Pts will participate in a 45-60-minute, one-on-one, audio-recorded interview. They will be conducted over the telephone or in person at the MSK Counseling Center. They will be conducted in accordance with a semi-structured interview guide developed by our study team of experts in clinical genetics, health psychology, & qualitative methodology. Topics to be covered in the interview include: 1) perceived potential benefits & harms of tumor genomic profiling; 2) interest in & perceived benefits & harms of incidental findings arising from tumor genomic profiling; 3) anticipated process & needs for decision-making about learning incidental findings; 4) interest in learning specific kinds of incidental findings (including those related to treatable diseases, different cancers, non-treatable diseases, & those that only have meaning for family members); 5) preferences about sharing incidental findings with other people; & 6) implications of & concerns about incidental findings for family.
arm group label: participants from existing MSK protocol 12-245
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jada Hamilton, PhD, MPH
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
facility: 
country: United States
url: http://www.mskcc.org/
description: Memorial Sloan Kettering Cancer Center
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
mesh term: Urinary Bladder Neoplasms