<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/NCT04427761</url>
  </required_header>
  <id_info>
    <org_study_id>20-038</org_study_id>
    <nct_id>NCT04427761</nct_id>
  </id_info>
  <brief_title>A Study of the Life Changes Experienced by Patients With Pancreatic Cancer</brief_title>
  <official_title>Health-Illness Transition Experiences Among Patients With Pancreatic Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hunter College School of Nursing</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Memorial Sloan Kettering Cancer Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to better understand what types of transitions people with&#xD;
      pancreatic cancer face when they receive chemotherapy. Again, this study defines transition&#xD;
      as a change in a life situation or a status that causes a change in a person's identity,&#xD;
      role, behavior, or personal relationships. Examples of transitions include changes in&#xD;
      sleeping habits, anxiety, employment, relationship with a higher power, and treatment goals.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 5, 2020</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Anticipated">June 2024</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Extent of the change experienced by patients with pancreatic cancer</measure>
    <time_frame>4 to 6 weeks after baseline</time_frame>
    <description>Descriptive statistics will be calculated at both time points using (part A on the MOT-CA) for each of the seven transition domains (physical, emotional, social, spiritual, cancer status, treatment, and approach) at both time points (Time 0 and Time 1).</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">55</enrollment>
  <condition>Pancreatic Cancer</condition>
  <arm_group>
    <arm_group_label>pancreatic cancer health-illness transition</arm_group_label>
    <description>In this prospective longitudinal correlational study, a convenience sample of patients with pancreatic cancer receiving chemotherapy will be asked to report on their health-illness transition experiences and their level of distress.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Measurement of Transitions in Cancer Scale (MOT-CA) Survey</intervention_name>
    <description>These surveys will take 5-10 minutes to complete at two time-points, T0 (baseline) and T1 (four to six weeks after baseline visit) The patient will again complete the DT and MOT-CA at a chemotherapy treatment or clinic visit, if possible, or via a telephone call with the principal investigator in the event that there are no in-person visits scheduled (Time 1).</description>
    <arm_group_label>pancreatic cancer health-illness transition</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Distress Thermometer Survey</intervention_name>
    <description>These surveys will take 5-10 minutes to complete at two time-points, T0 (baseline) and T1 (four to six weeks after baseline visit).The patient will again complete the DT and MOT-CA at a chemotherapy treatment or clinic visit, if possible, or via a telephone call with the principal investigator in the event that there are no in-person visits scheduled (Time 1).</description>
    <arm_group_label>pancreatic cancer health-illness transition</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Medical oncology clinic&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult patients 18 years of age and older&#xD;
&#xD;
          -  primary language listed as English in electronic medical record&#xD;
&#xD;
          -  biopsy proven diagnosis of pancreatic cancer&#xD;
&#xD;
          -  within three months after initiating a chemotherapy regimen at the Rockefeller&#xD;
             Outpatient Pavilion at MSKCC (patient may have previously received chemotherapy at an&#xD;
             outside institution or may have received previous chemotherapy regimens at MSKCC).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous history of cancer within the past five years, except for non-melanoma skin&#xD;
             cancer, ductal carcinoma in situ breast cancer, and thyroid cancer.&#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>Jessica Goldberg, RN, MSN, AGPCNP-BC, ACHPN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center (All Protocol Activities)</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/mskcc/html/44.cfm</url>
    <description>Memorial Sloan Kettering Cancer Center</description>
  </link>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>February 2, 2023</last_update_submitted>
  <last_update_submitted_qc>February 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Quality of Life</keyword>
  <keyword>Health-Illness Transition</keyword>
  <keyword>20-038</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.</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/NCT04427761
org study id: 20-038
nct id: NCT04427761
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to better understand what types of transitions people with
      pancreatic cancer face when they receive chemotherapy. Again, this study defines transition
      as a change in a life situation or a status that causes a change in a person's identity,
      role, behavior, or personal relationships. Examples of transitions include changes in
      sleeping habits, anxiety, employment, relationship with a higher power, and treatment goals.
observational model: Cohort
time perspective: Prospective
measure: Extent of the change experienced by patients with pancreatic cancer
time frame: 4 to 6 weeks after baseline
description: Descriptive statistics will be calculated at both time points using (part A on the MOT-CA) for each of the seven transition domains (physical, emotional, social, spiritual, cancer status, treatment, and approach) at both time points (Time 0 and Time 1).
arm group label: pancreatic cancer health-illness transition
description: In this prospective longitudinal correlational study, a convenience sample of patients with pancreatic cancer receiving chemotherapy will be asked to report on their health-illness transition experiences and their level of distress.
intervention type: Behavioral
intervention name: Measurement of Transitions in Cancer Scale (MOT-CA) Survey
description: These surveys will take 5-10 minutes to complete at two time-points, T0 (baseline) and T1 (four to six weeks after baseline visit) The patient will again complete the DT and MOT-CA at a chemotherapy treatment or clinic visit, if possible, or via a telephone call with the principal investigator in the event that there are no in-person visits scheduled (Time 1).
arm group label: pancreatic cancer health-illness transition
intervention type: Behavioral
intervention name: Distress Thermometer Survey
description: These surveys will take 5-10 minutes to complete at two time-points, T0 (baseline) and T1 (four to six weeks after baseline visit).The patient will again complete the DT and MOT-CA at a chemotherapy treatment or clinic visit, if possible, or via a telephone call with the principal investigator in the event that there are no in-person visits scheduled (Time 1).
arm group label: pancreatic cancer health-illness transition
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jessica Goldberg, RN, MSN, AGPCNP-BC, ACHPN
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
facility: 
country: United States
url: http://www.mskcc.org/mskcc/html/44.cfm
description: Memorial Sloan Kettering Cancer Center
responsible party type: Sponsor
mesh term: Pancreatic Neoplasms
sharing ipd: Yes
ipd description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.