<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/NCT04501913</url>
  </required_header>
  <id_info>
    <org_study_id>19040</org_study_id>
    <secondary_id>NCI-2020-03377</secondary_id>
    <secondary_id>19040</secondary_id>
    <secondary_id>P30CA033572</secondary_id>
    <nct_id>NCT04501913</nct_id>
  </id_info>
  <brief_title>Remote Telemonitoring of Patient-Generated Physiologic Health Data and Patient-Reported Outcomes</brief_title>
  <official_title>Remote Perioperative Telemonitoring of Patient-Generated Physiologic Health Data and Patient-Reported Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>City of Hope Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>City of Hope Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study examines at-home monitoring of patient-generated phsyiologic health data and&#xD;
      patient-reported outcomes. Patient-generated health data using at-home monitoring devices and&#xD;
      smart device applications are used more and more to measure value and quality in cancer care.&#xD;
      This trial may show whether at-home monitoring programs can improve the care of patients&#xD;
      after hospital discharge from surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To assess the feasibility and acceptability of remote perioperative monitoring in solid&#xD;
      tumor cancer patients scheduled for gastrointestinal (GI), genitourinary (GU), gynecological&#xD;
      (GYN) cancer surgery.&#xD;
&#xD;
      II. To explore patterns, trajectory, and changes in physiologic health parameter outcomes&#xD;
      (weight, temperature, oxygen saturation, heart rate, blood pressure, daily steps) and&#xD;
      patient-reported outcomes (PROs) (symptoms, quality of life [QOL]) from pre-surgery to the&#xD;
      post-discharge period.&#xD;
&#xD;
      III. To explore the relationship between changes in physiologic health parameter&#xD;
      outcomes/PROs and surgical outcomes (postoperative complications, readmissions).&#xD;
&#xD;
      IV. To explore changes in physiologic health parameters and PROs by open surgery versus&#xD;
      minimally invasive (laparoscopic or robotic) surgery.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients undergo remote perioperative telemonitoring with home monitoring devices activity&#xD;
      monitor beginning 7 days before surgery and up to 30 days after hospital discharge.&#xD;
&#xD;
      After completion of study, patients are followed up for 2 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 24, 2019</start_date>
  <completion_date type="Anticipated">December 24, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 24, 2023</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>Overall accrual</measure>
    <time_frame>Days 2</time_frame>
    <description>Planned accrual is bound by the number of eligibile patients and duration of the study funding. Accrual goal is 20 patients.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall accrual</measure>
    <time_frame>Days 7</time_frame>
    <description>Planned accrual is bound by the number of eligibile patients and duration of the study funding. Accrual goal is 20 patients.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall accrual</measure>
    <time_frame>Days 14</time_frame>
    <description>Planned accrual is bound by the number of eligibile patients and duration of the study funding. Accrual goal is 20 patients.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall accrual</measure>
    <time_frame>Days 30 after discharge</time_frame>
    <description>Planned accrual is bound by the number of eligibile patients and duration of the study funding. Accrual goal is 20 patients.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Retention</measure>
    <time_frame>Days 2</time_frame>
    <description>Participants' retention will be assessed at all follow-up timepoints by remaining enrolled on study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Retention</measure>
    <time_frame>Days 7</time_frame>
    <description>Participants' retention will be assessed at all follow-up timepoints by remaining enrolled on study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Retention</measure>
    <time_frame>Days 14</time_frame>
    <description>Participants' retention will be assessed at all follow-up timepoints by remaining enrolled on study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Retention</measure>
    <time_frame>Days 30 after discharge</time_frame>
    <description>Participants' retention will be assessed at all follow-up timepoints by remaining enrolled on study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Attrition rates</measure>
    <time_frame>Days 2</time_frame>
    <description>All participants that are enrolled will be tracked and assessed for drop off (attrition) at all time points.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Attrition rates</measure>
    <time_frame>Days 7</time_frame>
    <description>All participants that are enrolled will be tracked and assessed for drop off (attrition) at all time points.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Attrition rates</measure>
    <time_frame>Days 14</time_frame>
    <description>All participants that are enrolled will be tracked and assessed for drop off (attrition) at all time points.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Attrition rates</measure>
    <time_frame>Days 30 after discharge</time_frame>
    <description>All participants that are enrolled will be tracked and assessed for drop off (attrition) at all time points.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient's ability to use the remote perioperative monitoring equipment</measure>
    <time_frame>Up to 30 days</time_frame>
    <description>At least 75% of patients will be able to wear the wristband pedometer for at least 1 week post-operatively, and at least 75% of the patients will be able to use at least 2 out of 4 physiologic devices (scale, pulse/heart monitor, blood pressure cuff, and thermometer) at least once a week.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Staff ability to identify threshold healthcare parameters</measure>
    <time_frame>Up to 30 days</time_frame>
    <description>Staff will be alerted through a workflow guided by the threshold healthcare parameters. The number of alerts of data outside parameters will be recorded as well as the initiated response to each alert.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Staff ability to act on identified threshold healthcare parameters</measure>
    <time_frame>Up to 30 days</time_frame>
    <description>The number of alerts and resolved alerts will be captured in response to threshold parameters in addition to a nurse debriefing form to summarize the response</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patterns, trajectory, and changes in patient-generated health data (PGHD)</measure>
    <time_frame>Up to 30 days</time_frame>
    <description>After discharge, all patient-generated physiologic data will be repeated at day 7,14,,and day 30 to measure any differences in weight, temperature, oxygen saturation, heart rate, blood pressure and functional activity using the Aetonix devices and Vivofit watches</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported outcomes (PROs) (symptoms, quality of life [QOL]) between groups</measure>
    <time_frame>From pre-surgery to the post-discharge period</time_frame>
    <description>Quality of Life will be measured through the EQ-5D-5L and PROMIS 4 QOL measurement tools</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in PGHD/PROs</measure>
    <time_frame>Up to 30 days after surgery</time_frame>
    <description>Distributions of PGHD/PROs will be generated. Means, standard deviations, and ranges will be calculated for continuous variables, and frequencies and percentages for categorical variables. All PROs will be scored according to instructions. Analysis of variance (ANOVA) will be used to study patterns of change over time in PROs administered at multiple time points.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">22</enrollment>
  <condition>Clinical Stage 0 Esophageal Adenocarcinoma AJCC v8</condition>
  <condition>Clinical Stage 0 Esophageal Squamous Cell Carcinoma AJCC v8</condition>
  <condition>Clinical Stage 0 Gastric Cancer AJCC v8</condition>
  <condition>Clinical Stage I Esophageal Adenocarcinoma AJCC v8</condition>
  <condition>Clinical Stage I Esophageal Squamous Cell Carcinoma AJCC v8</condition>
  <condition>Clinical Stage I Gastric Cancer AJCC v8</condition>
  <condition>Clinical Stage II Esophageal Adenocarcinoma AJCC v8</condition>
  <condition>Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8</condition>
  <condition>Clinical Stage II Gastric Cancer AJCC v8</condition>
  <condition>Clinical Stage IIA Esophageal Adenocarcinoma AJCC v8</condition>
  <condition>Clinical Stage IIA Gastric Cancer AJCC v8</condition>
  <condition>Clinical Stage IIB Esophageal Adenocarcinoma AJCC v8</condition>
  <condition>Clinical Stage IIB Gastric Cancer AJCC v8</condition>
  <condition>Clinical Stage III Esophageal Adenocarcinoma AJCC v8</condition>
  <condition>Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8</condition>
  <condition>Clinical Stage III Gastric Cancer AJCC v8</condition>
  <condition>Clinical Stage IV Esophageal Adenocarcinoma AJCC v8</condition>
  <condition>Clinical Stage IV Esophageal Squamous Cell Carcinoma AJCC v8</condition>
  <condition>Clinical Stage IV Gastric Cancer AJCC v8</condition>
  <condition>Clinical Stage IVA Esophageal Adenocarcinoma AJCC v8</condition>
  <condition>Clinical Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8</condition>
  <condition>Clinical Stage IVA Gastric Cancer AJCC v8</condition>
  <condition>Clinical Stage IVB Esophageal Adenocarcinoma AJCC v8</condition>
  <condition>Clinical Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8</condition>
  <condition>Clinical Stage IVB Gastric Cancer AJCC v8</condition>
  <condition>Hepatobiliary Neoplasm</condition>
  <condition>Malignant Digestive System Neoplasm</condition>
  <condition>Malignant Female Reproductive System Neoplasm</condition>
  <condition>Malignant Genitourinary System Neoplasm</condition>
  <condition>Malignant Neoplasm</condition>
  <condition>Pathologic Stage 0 Esophageal Adenocarcinoma AJCC v8</condition>
  <condition>Pathologic Stage 0 Esophageal Squamous Cell Carcinoma AJCC v8</condition>
  <condition>Pathologic Stage 0 Gastric Cancer AJCC v8</condition>
  <condition>Pathologic Stage I Esophageal Adenocarcinoma AJCC v8</condition>
  <condition>Pathologic Stage I Esophageal Squamous Cell Carcinoma AJCC v8</condition>
  <condition>Pathologic Stage I Gastric Cancer AJCC v8</condition>
  <condition>Pathologic Stage IA Esophageal Adenocarcinoma AJCC v8</condition>
  <condition>Pathologic Stage IA Esophageal Squamous Cell Carcinoma AJCC v8</condition>
  <condition>Pathologic Stage IA Gastric Cancer AJCC v8</condition>
  <condition>Pathologic Stage IB Esophageal Adenocarcinoma AJCC v8</condition>
  <condition>Pathologic Stage IB Esophageal Squamous Cell Carcinoma AJCC v8</condition>
  <condition>Pathologic Stage IB Gastric Cancer AJCC v8</condition>
  <condition>Pathologic Stage IC Esophageal Adenocarcinoma AJCC v8</condition>
  <condition>Pathologic Stage II Esophageal Adenocarcinoma AJCC v8</condition>
  <condition>Pathologic Stage II Esophageal Squamous Cell Carcinoma AJCC v8</condition>
  <condition>Pathologic Stage II Gastric Cancer AJCC v8</condition>
  <condition>Pathologic Stage IIA Esophageal Adenocarcinoma AJCC v8</condition>
  <condition>Pathologic Stage IIA Esophageal Squamous Cell Carcinoma AJCC v8</condition>
  <condition>Pathologic Stage IIA Gastric Cancer AJCC v8</condition>
  <condition>Pathologic Stage IIB Esophageal Adenocarcinoma AJCC v8</condition>
  <condition>Pathologic Stage IIB Esophageal Squamous Cell Carcinoma AJCC v8</condition>
  <condition>Pathologic Stage IIB Gastric Cancer AJCC v8</condition>
  <condition>Pathologic Stage III Esophageal Adenocarcinoma AJCC v8</condition>
  <condition>Pathologic Stage III Esophageal Squamous Cell Carcinoma AJCC v8</condition>
  <condition>Pathologic Stage III Gastric Cancer AJCC v8</condition>
  <condition>Pathologic Stage IIIA Esophageal Adenocarcinoma AJCC v8</condition>
  <condition>Pathologic Stage IIIA Esophageal Squamous Cell Carcinoma AJCC v8</condition>
  <condition>Pathologic Stage IIIA Gastric Cancer AJCC v8</condition>
  <condition>Pathologic Stage IIIB Esophageal Adenocarcinoma AJCC v8</condition>
  <condition>Pathologic Stage IIIB Esophageal Squamous Cell Carcinoma AJCC v8</condition>
  <condition>Pathologic Stage IIIB Gastric Cancer AJCC v8</condition>
  <condition>Pathologic Stage IIIC Gastric Cancer AJCC v8</condition>
  <condition>Pathologic Stage IV Esophageal Adenocarcinoma AJCC v8</condition>
  <condition>Pathologic Stage IV Esophageal Squamous Cell Carcinoma AJCC v8</condition>
  <condition>Pathologic Stage IV Gastric Cancer AJCC v8</condition>
  <condition>Pathologic Stage IVA Esophageal Adenocarcinoma AJCC v8</condition>
  <condition>Pathologic Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8</condition>
  <condition>Pathologic Stage IVB Esophageal Adenocarcinoma AJCC v8</condition>
  <condition>Pathologic Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8</condition>
  <condition>Postneoadjuvant Therapy Stage I Esophageal Adenocarcinoma AJCC v8</condition>
  <condition>Postneoadjuvant Therapy Stage I Esophageal Squamous Cell Carcinoma AJCC v8</condition>
  <condition>Postneoadjuvant Therapy Stage II Esophageal Adenocarcinoma AJCC v8</condition>
  <condition>Postneoadjuvant Therapy Stage II Esophageal Squamous Cell Carcinoma AJCC v8</condition>
  <condition>Postneoadjuvant Therapy Stage III Esophageal Adenocarcinoma AJCC v8</condition>
  <condition>Postneoadjuvant Therapy Stage III Esophageal Squamous Cell Carcinoma AJCC v8</condition>
  <condition>Postneoadjuvant Therapy Stage IIIA Esophageal Adenocarcinoma AJCC v8</condition>
  <condition>Postneoadjuvant Therapy Stage IIIA Esophageal Squamous Cell Carcinoma AJCC v8</condition>
  <condition>Postneoadjuvant Therapy Stage IIIB Esophageal Adenocarcinoma AJCC v8</condition>
  <condition>Postneoadjuvant Therapy Stage IIIB Esophageal Squamous Cell Carcinoma AJCC v8</condition>
  <condition>Postneoadjuvant Therapy Stage IV Esophageal Adenocarcinoma AJCC v8</condition>
  <condition>Postneoadjuvant Therapy Stage IV Esophageal Squamous Cell Carcinoma AJCC v8</condition>
  <condition>Postneoadjuvant Therapy Stage IVA Esophageal Adenocarcinoma AJCC v8</condition>
  <condition>Postneoadjuvant Therapy Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8</condition>
  <condition>Postneoadjuvant Therapy Stage IVB Esophageal Adenocarcinoma AJCC v8</condition>
  <condition>Postneoadjuvant Therapy Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8</condition>
  <condition>Stage 0 Colorectal Cancer AJCC v8</condition>
  <condition>Stage 0a Bladder Cancer AJCC v8</condition>
  <condition>Stage 0is Bladder Cancer AJCC v8</condition>
  <condition>Stage I Bladder Cancer AJCC v8</condition>
  <condition>Stage I Cervical Cancer AJCC v8</condition>
  <condition>Stage I Colorectal Cancer AJCC v8</condition>
  <condition>Stage I Ovarian Cancer AJCC v8</condition>
  <condition>Stage I Prostate Cancer AJCC v8</condition>
  <condition>Stage I Renal Cell Cancer AJCC v8</condition>
  <condition>Stage I Uterine Corpus Cancer AJCC v8</condition>
  <condition>Stage IA Cervical Cancer AJCC v8</condition>
  <condition>Stage IA Ovarian Cancer AJCC v8</condition>
  <condition>Stage IA Uterine Corpus Cancer AJCC v8</condition>
  <condition>Stage IA1 Cervical Cancer AJCC v8</condition>
  <condition>Stage IA2 Cervical Cancer AJCC v8</condition>
  <condition>Stage IB Cervical Cancer AJCC v8</condition>
  <condition>Stage IB Ovarian Cancer AJCC v8</condition>
  <condition>Stage IB Uterine Corpus Cancer AJCC v8</condition>
  <condition>Stage IB1 Cervical Cancer AJCC v8</condition>
  <condition>Stage IB2 Cervical Cancer AJCC v8</condition>
  <condition>Stage IC Ovarian Cancer AJCC v8</condition>
  <condition>Stage II Bladder Cancer AJCC v8</condition>
  <condition>Stage II Cervical Cancer AJCC v8</condition>
  <condition>Stage II Colorectal Cancer AJCC v8</condition>
  <condition>Stage II Ovarian Cancer AJCC v8</condition>
  <condition>Stage II Prostate Cancer AJCC v8</condition>
  <condition>Stage II Renal Cell Cancer AJCC v8</condition>
  <condition>Stage II Uterine Corpus Cancer AJCC v8</condition>
  <condition>Stage IIA Cervical Cancer AJCC v8</condition>
  <condition>Stage IIA Colorectal Cancer AJCC v8</condition>
  <condition>Stage IIA Ovarian Cancer AJCC v8</condition>
  <condition>Stage IIA Prostate Cancer AJCC v8</condition>
  <condition>Stage IIA1 Cervical Cancer AJCC v8</condition>
  <condition>Stage IIA2 Cervical Cancer AJCC v8</condition>
  <condition>Stage IIB Cervical Cancer AJCC v8</condition>
  <condition>Stage IIB Colorectal Cancer AJCC v8</condition>
  <condition>Stage IIB Ovarian Cancer AJCC v8</condition>
  <condition>Stage IIB Prostate Cancer AJCC v8</condition>
  <condition>Stage IIC Colorectal Cancer AJCC v8</condition>
  <condition>Stage IIC Prostate Cancer AJCC v8</condition>
  <condition>Stage III Bladder Cancer AJCC v8</condition>
  <condition>Stage III Cervical Cancer AJCC v8</condition>
  <condition>Stage III Colorectal Cancer AJCC v8</condition>
  <condition>Stage III Ovarian Cancer AJCC v8</condition>
  <condition>Stage III Prostate Cancer AJCC v8</condition>
  <condition>Stage III Renal Cell Cancer AJCC v8</condition>
  <condition>Stage III Uterine Corpus Cancer AJCC v8</condition>
  <condition>Stage IIIA Bladder Cancer AJCC v8</condition>
  <condition>Stage IIIA Cervical Cancer AJCC v8</condition>
  <condition>Stage IIIA Colorectal Cancer AJCC v8</condition>
  <condition>Stage IIIA Ovarian Cancer AJCC v8</condition>
  <condition>Stage IIIA Prostate Cancer AJCC v8</condition>
  <condition>Stage IIIA Uterine Corpus Cancer AJCC v8</condition>
  <condition>Stage IIIA1 Ovarian Cancer AJCC v8</condition>
  <condition>Stage IIIA2 Ovarian Cancer AJCC v8</condition>
  <condition>Stage IIIB Bladder Cancer AJCC v8</condition>
  <condition>Stage IIIB Cervical Cancer AJCC v8</condition>
  <condition>Stage IIIB Colorectal Cancer AJCC v8</condition>
  <condition>Stage IIIB Ovarian Cancer AJCC v8</condition>
  <condition>Stage IIIB Prostate Cancer AJCC v8</condition>
  <condition>Stage IIIB Uterine Corpus Cancer AJCC v8</condition>
  <condition>Stage IIIC Colorectal Cancer AJCC v8</condition>
  <condition>Stage IIIC Ovarian Cancer AJCC v8</condition>
  <condition>Stage IIIC Prostate Cancer AJCC v8</condition>
  <condition>Stage IIIC Uterine Corpus Cancer AJCC v8</condition>
  <condition>Stage IIIC1 Uterine Corpus Cancer AJCC v8</condition>
  <condition>Stage IIIC2 Uterine Corpus Cancer AJCC v8</condition>
  <condition>Stage IV Bladder Cancer AJCC v8</condition>
  <condition>Stage IV Cervical Cancer AJCC v8</condition>
  <condition>Stage IV Colorectal Cancer AJCC v8</condition>
  <condition>Stage IV Ovarian Cancer AJCC v8</condition>
  <condition>Stage IV Prostate Cancer AJCC v8</condition>
  <condition>Stage IV Renal Cell Cancer AJCC v8</condition>
  <condition>Stage IV Uterine Corpus Cancer AJCC v8</condition>
  <condition>Stage IVA Bladder Cancer AJCC v8</condition>
  <condition>Stage IVA Cervical Cancer AJCC v8</condition>
  <condition>Stage IVA Colorectal Cancer AJCC v8</condition>
  <condition>Stage IVA Ovarian Cancer AJCC v8</condition>
  <condition>Stage IVA Prostate Cancer AJCC v8</condition>
  <condition>Stage IVA Uterine Corpus Cancer AJCC v8</condition>
  <condition>Stage IVB Bladder Cancer AJCC v8</condition>
  <condition>Stage IVB Cervical Cancer AJCC v8</condition>
  <condition>Stage IVB Colorectal Cancer AJCC v8</condition>
  <condition>Stage IVB Ovarian Cancer AJCC v8</condition>
  <condition>Stage IVB Prostate Cancer AJCC v8</condition>
  <condition>Stage IVB Uterine Corpus Cancer AJCC v8</condition>
  <condition>Stage IVC Colorectal Cancer AJCC v8</condition>
  <arm_group>
    <arm_group_label>Observational (remote telemonitoring)</arm_group_label>
    <description>Patients undergo remote perioperative telemonitoring with home monitoring devices activity monitor beginning 7 days before surgery and up to 30 days after hospital discharge.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Patient Monitoring</intervention_name>
    <description>Undergo remote perioperative telemonitoring</description>
    <arm_group_label>Observational (remote telemonitoring)</arm_group_label>
    <other_name>medical monitoring</other_name>
    <other_name>monitor</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Complete questionnaires</description>
    <arm_group_label>Observational (remote telemonitoring)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Cancer patients diagnosed with gastrointestinal, genitourinary, or gynecological cancers&#xD;
        who are scheduled to undergo abdominal/pelvic surgery at the City of Hope National Medical&#xD;
        Center&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cancer patients diagnosed with GI (esophagus, gastric, colorectal, hepatobiliary) GU&#xD;
             (prostate, bladder, renal cell), or GYN (ovarian, endometrial, cervical) cancers&#xD;
&#xD;
          -  Patients who are scheduled to undergo major abdominal/pelvic surgery for cancer&#xD;
             treatment&#xD;
&#xD;
          -  Ability to read and understand English&#xD;
&#xD;
          -  We are targeting patients across all stages of disease&#xD;
&#xD;
          -  All subjects must have the ability to understand and the willingness to sign a written&#xD;
             informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects, who in the opinion of the investigator, may not be able to comply with the&#xD;
             safety monitoring requirements of the study&#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>Laleh Melstrom</last_name>
    <role>Principal Investigator</role>
    <affiliation>City of Hope Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>City of Hope Medical Center</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>June 19, 2023</last_update_submitted>
  <last_update_submitted_qc>June 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 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>Carcinoma</mesh_term>
    <mesh_term>Prostatic Neoplasms</mesh_term>
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Colorectal Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Squamous Cell</mesh_term>
    <mesh_term>Adenocarcinoma</mesh_term>
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
    <mesh_term>Stomach Neoplasms</mesh_term>
    <mesh_term>Uterine Cervical Neoplasms</mesh_term>
    <mesh_term>Urinary Bladder Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Renal Cell</mesh_term>
    <mesh_term>Esophageal Squamous Cell Carcinoma</mesh_term>
    <mesh_term>Esophageal Neoplasms</mesh_term>
    <mesh_term>Digestive System Neoplasms</mesh_term>
    <mesh_term>Gastrointestinal Neoplasms</mesh_term>
    <mesh_term>Genital Neoplasms, Female</mesh_term>
    <mesh_term>Carcinoma in Situ</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/NCT04501913
org study id: 19040
secondary id: NCI-2020-03377
secondary id: 19040
secondary id: P30CA033572
nct id: NCT04501913
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study examines at-home monitoring of patient-generated phsyiologic health data and
      patient-reported outcomes. Patient-generated health data using at-home monitoring devices and
      smart device applications are used more and more to measure value and quality in cancer care.
      This trial may show whether at-home monitoring programs can improve the care of patients
      after hospital discharge from surgery.
PRIMARY OBJECTIVES:

      I. To assess the feasibility and acceptability of remote perioperative monitoring in solid
      tumor cancer patients scheduled for gastrointestinal (GI), genitourinary (GU), gynecological
      (GYN) cancer surgery.

      II. To explore patterns, trajectory, and changes in physiologic health parameter outcomes
      (weight, temperature, oxygen saturation, heart rate, blood pressure, daily steps) and
      patient-reported outcomes (PROs) (symptoms, quality of life [QOL]) from pre-surgery to the
      post-discharge period.

      III. To explore the relationship between changes in physiologic health parameter
      outcomes/PROs and surgical outcomes (postoperative complications, readmissions).

      IV. To explore changes in physiologic health parameters and PROs by open surgery versus
      minimally invasive (laparoscopic or robotic) surgery.

      OUTLINE:

      Patients undergo remote perioperative telemonitoring with home monitoring devices activity
      monitor beginning 7 days before surgery and up to 30 days after hospital discharge.

      After completion of study, patients are followed up for 2 months.
observational model: Cohort
time perspective: Prospective
measure: Overall accrual
time frame: Days 2
description: Planned accrual is bound by the number of eligibile patients and duration of the study funding. Accrual goal is 20 patients.
measure: Overall accrual
time frame: Days 7
description: Planned accrual is bound by the number of eligibile patients and duration of the study funding. Accrual goal is 20 patients.
measure: Overall accrual
time frame: Days 14
description: Planned accrual is bound by the number of eligibile patients and duration of the study funding. Accrual goal is 20 patients.
measure: Overall accrual
time frame: Days 30 after discharge
description: Planned accrual is bound by the number of eligibile patients and duration of the study funding. Accrual goal is 20 patients.
measure: Retention
time frame: Days 2
description: Participants' retention will be assessed at all follow-up timepoints by remaining enrolled on study.
measure: Retention
time frame: Days 7
description: Participants' retention will be assessed at all follow-up timepoints by remaining enrolled on study.
measure: Retention
time frame: Days 14
description: Participants' retention will be assessed at all follow-up timepoints by remaining enrolled on study.
measure: Retention
time frame: Days 30 after discharge
description: Participants' retention will be assessed at all follow-up timepoints by remaining enrolled on study.
measure: Attrition rates
time frame: Days 2
description: All participants that are enrolled will be tracked and assessed for drop off (attrition) at all time points.
measure: Attrition rates
time frame: Days 7
description: All participants that are enrolled will be tracked and assessed for drop off (attrition) at all time points.
measure: Attrition rates
time frame: Days 14
description: All participants that are enrolled will be tracked and assessed for drop off (attrition) at all time points.
measure: Attrition rates
time frame: Days 30 after discharge
description: All participants that are enrolled will be tracked and assessed for drop off (attrition) at all time points.
measure: Patient's ability to use the remote perioperative monitoring equipment
time frame: Up to 30 days
description: At least 75% of patients will be able to wear the wristband pedometer for at least 1 week post-operatively, and at least 75% of the patients will be able to use at least 2 out of 4 physiologic devices (scale, pulse/heart monitor, blood pressure cuff, and thermometer) at least once a week.
measure: Staff ability to identify threshold healthcare parameters
time frame: Up to 30 days
description: Staff will be alerted through a workflow guided by the threshold healthcare parameters. The number of alerts of data outside parameters will be recorded as well as the initiated response to each alert.
measure: Staff ability to act on identified threshold healthcare parameters
time frame: Up to 30 days
description: The number of alerts and resolved alerts will be captured in response to threshold parameters in addition to a nurse debriefing form to summarize the response
measure: Patterns, trajectory, and changes in patient-generated health data (PGHD)
time frame: Up to 30 days
description: After discharge, all patient-generated physiologic data will be repeated at day 7,14,,and day 30 to measure any differences in weight, temperature, oxygen saturation, heart rate, blood pressure and functional activity using the Aetonix devices and Vivofit watches
measure: Patient reported outcomes (PROs) (symptoms, quality of life [QOL]) between groups
time frame: From pre-surgery to the post-discharge period
description: Quality of Life will be measured through the EQ-5D-5L and PROMIS 4 QOL measurement tools
measure: Changes in PGHD/PROs
time frame: Up to 30 days after surgery
description: Distributions of PGHD/PROs will be generated. Means, standard deviations, and ranges will be calculated for continuous variables, and frequencies and percentages for categorical variables. All PROs will be scored according to instructions. Analysis of variance (ANOVA) will be used to study patterns of change over time in PROs administered at multiple time points.
arm group label: Observational (remote telemonitoring)
description: Patients undergo remote perioperative telemonitoring with home monitoring devices activity monitor beginning 7 days before surgery and up to 30 days after hospital discharge.
intervention type: Procedure
intervention name: Patient Monitoring
description: Undergo remote perioperative telemonitoring
arm group label: Observational (remote telemonitoring)
other name: medical monitoring
other name: monitor
intervention type: Other
intervention name: Questionnaire Administration
description: Complete questionnaires
arm group label: Observational (remote telemonitoring)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Laleh Melstrom
role: Principal Investigator
affiliation: City of Hope Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Prostatic Neoplasms
mesh term: Neoplasms
mesh term: Colorectal Neoplasms
mesh term: Carcinoma, Squamous Cell
mesh term: Adenocarcinoma
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
mesh term: Stomach Neoplasms
mesh term: Uterine Cervical Neoplasms
mesh term: Urinary Bladder Neoplasms
mesh term: Carcinoma, Renal Cell
mesh term: Esophageal Squamous Cell Carcinoma
mesh term: Esophageal Neoplasms
mesh term: Digestive System Neoplasms
mesh term: Gastrointestinal Neoplasms
mesh term: Genital Neoplasms, Female
mesh term: Carcinoma in Situ