<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/NCT03026699</url>
  </required_header>
  <id_info>
    <org_study_id>MCC-18378</org_study_id>
    <secondary_id>R03CA201684-01</secondary_id>
    <nct_id>NCT03026699</nct_id>
  </id_info>
  <brief_title>Refining and Testing the Electronic Social Network Assessment Program (eSNAP)</brief_title>
  <official_title>Refining and Testing the Electronic Social Network Assessment Program (eSNAP)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>H. Lee Moffitt Cancer Center and Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Utah</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>H. Lee Moffitt Cancer Center and Research Institute</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>
      The purpose of the study is to learn more about neuro-oncology caregivers' quality of life&#xD;
      and how friends and families help neuro-oncology cancer caregivers at different times during&#xD;
      treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Former Aim 1: Refine eSNAP data-gathering and visualization prototypes based on evaluations&#xD;
      of user experience, including usability, satisfaction and applicability. The refining process&#xD;
      was completed at the University of Utah.&#xD;
&#xD;
      Aim 2: Test the feasibility of implementing eSNAP in a neuro-oncology clinical setting and&#xD;
      collect preliminary effectiveness data of eSNAP on Family Caregiver outcomes, including&#xD;
      quality of life and stress, and mediators (Family Caregiver social support utilization and&#xD;
      burden). The feasibility process will take place at Moffitt Cancer Center.&#xD;
&#xD;
      This study will be a 2x2 longitudinal design. Caregivers of primary brain tumor patients will&#xD;
      be compared to caregivers of patients with secondary brain tumors (brain metastases) to&#xD;
      determine if there is something unique about the cancer-specific duties of primary versus&#xD;
      secondary brain tumors that could impact the effectiveness of the eSNAP application. An&#xD;
      intervention group will be compared to a control group for both types of caregivers.&#xD;
      Participants will be randomized 2:1 for the intervention and control. All caregivers will be&#xD;
      followed for 6 weeks and will be asked to complete questionnaires at 3 time points;&#xD;
      caregivers in the intervention group will also be asked to use the eSNAP application at time&#xD;
      1, which will be available to them for the duration of the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 5, 2017</start_date>
  <completion_date type="Actual">October 17, 2017</completion_date>
  <primary_completion_date type="Actual">October 17, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Questionnaire Participation Among Participant Groups</measure>
    <time_frame>6 weeks per participant</time_frame>
    <description>Feasibility 1: Recruitment rates per group.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Retention of Participants Among Participant Groups</measure>
    <time_frame>6 weeks per participant</time_frame>
    <description>Feasibility 2: Retention rates per group.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Stress and Coping - Quality of Life Among Participant Groups</measure>
    <time_frame>6 weeks per participant</time_frame>
    <description>Although not reaching adequate power to detect differences, planned analysis will allow investigators to estimate effect size of eSNAP at baseline as well as the effect of cancer type. (Power analysis conducted in G*Power for ANOVA using effect size 0.2 a=.05 for 3 groups for power of 0.80 requires a sample of 246.) ANOVA will be conducted to determine if groups vary on stress and quality of life at baseline. Growth-curve analysis will be used to identify potential preliminary differences in the eSNAP group over time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Social Support - Quality of Life Among Participant Groups</measure>
    <time_frame>6 weeks per participant</time_frame>
    <description>Chi square and generalized linear model (GLM) will be used to analyze utilization of support services differences.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Clinic Disruption</measure>
    <time_frame>6 weeks per participant</time_frame>
    <description>Incidence of clinic disruption per participant group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Problems with eSNAP implementation</measure>
    <time_frame>6 weeks per participant</time_frame>
    <description>Chi square and generalized linear model (GLM) will be used to analyze trends in satisfaction or time spent on ecomapping/eSNAP.</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">62</enrollment>
  <condition>Brain Cancer</condition>
  <arm_group>
    <arm_group_label>Intervention - Primary Brain Tumor</arm_group_label>
    <description>eSNAP Intervention Plus Questionnaires: Family caregivers of primary brain tumor patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention - Secondary Brain Tumor</arm_group_label>
    <description>eSNAP Intervention Plus Questionnaires: Family caregivers of secondary brain tumor patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control - Primary Brain Tumor</arm_group_label>
    <description>Questionnaires Only Control: Family caregivers of primary brain tumor patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control - Secondary Brain Tumor</arm_group_label>
    <description>Questionnaires Only Control: Family caregivers of secondary brain tumor patients.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>eSNAP</intervention_name>
    <description>Participants in the intervention group will then be given a tablet loaded with the eSNAP application and asked to create a visualization of their social networks. Upon completion, participants will be asked to review their ecomaps and complete the user experience questionnaire.</description>
    <arm_group_label>Intervention - Primary Brain Tumor</arm_group_label>
    <arm_group_label>Intervention - Secondary Brain Tumor</arm_group_label>
    <other_name>Electronic Social Network Assessment Program</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Questionnaires</intervention_name>
    <description>Participants will complete demographics and baseline (T1; baseline) questionnaires. For all participants Time 2 (T2; 3 week) and Time 3 (T3; 6 week) questionnaires will be completed either by phone, mail, or email (depending on participant preference) to assess longer-term effects of eSNAP on outcomes versus controls.</description>
    <arm_group_label>Control - Primary Brain Tumor</arm_group_label>
    <arm_group_label>Control - Secondary Brain Tumor</arm_group_label>
    <arm_group_label>Intervention - Primary Brain Tumor</arm_group_label>
    <arm_group_label>Intervention - Secondary Brain Tumor</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants will be family caregivers recruited from the Moffitt Cancer Center Radiation&#xD;
        Oncology Clinic.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Family caregiver of a patient with primary or secondary brain tumor&#xD;
&#xD;
          -  Age 18 years or older&#xD;
&#xD;
          -  Able to speak and write English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Does not meet the Inclusion Criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maija Reblin, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>H. Lee Moffitt Cancer Center and Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>H. Lee Moffitt Cancer Center and Research Institute</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://moffitt.org/clinical-trials-research/</url>
    <description>Moffitt Cancer Center Clinical Trials website</description>
  </link>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>December 1, 2020</last_update_submitted>
  <last_update_submitted_qc>December 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Brain</keyword>
  <keyword>Nervous system</keyword>
  <keyword>Neuro-oncology</keyword>
  <keyword>Caregivers</keyword>
  <keyword>Cancer patient</keyword>
  <keyword>Family caregivers</keyword>
  <keyword>Brain tumors</keyword>
  <keyword>Quality of life</keyword>
  <keyword>Stress</keyword>
  <keyword>Social support</keyword>
  <keyword>Feasibility</keyword>
  <keyword>Electronic Social Network Assessment Program (eSNAP)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain 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/NCT03026699
org study id: MCC-18378
secondary id: R03CA201684-01
nct id: NCT03026699
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to learn more about neuro-oncology caregivers' quality of life
      and how friends and families help neuro-oncology cancer caregivers at different times during
      treatment.
Former Aim 1: Refine eSNAP data-gathering and visualization prototypes based on evaluations
      of user experience, including usability, satisfaction and applicability. The refining process
      was completed at the University of Utah.

      Aim 2: Test the feasibility of implementing eSNAP in a neuro-oncology clinical setting and
      collect preliminary effectiveness data of eSNAP on Family Caregiver outcomes, including
      quality of life and stress, and mediators (Family Caregiver social support utilization and
      burden). The feasibility process will take place at Moffitt Cancer Center.

      This study will be a 2x2 longitudinal design. Caregivers of primary brain tumor patients will
      be compared to caregivers of patients with secondary brain tumors (brain metastases) to
      determine if there is something unique about the cancer-specific duties of primary versus
      secondary brain tumors that could impact the effectiveness of the eSNAP application. An
      intervention group will be compared to a control group for both types of caregivers.
      Participants will be randomized 2:1 for the intervention and control. All caregivers will be
      followed for 6 weeks and will be asked to complete questionnaires at 3 time points;
      caregivers in the intervention group will also be asked to use the eSNAP application at time
      1, which will be available to them for the duration of the study.
observational model: Case-Control
time perspective: Retrospective
measure: Questionnaire Participation Among Participant Groups
time frame: 6 weeks per participant
description: Feasibility 1: Recruitment rates per group.
measure: Retention of Participants Among Participant Groups
time frame: 6 weeks per participant
description: Feasibility 2: Retention rates per group.
measure: Stress and Coping - Quality of Life Among Participant Groups
time frame: 6 weeks per participant
description: Although not reaching adequate power to detect differences, planned analysis will allow investigators to estimate effect size of eSNAP at baseline as well as the effect of cancer type. (Power analysis conducted in G*Power for ANOVA using effect size 0.2 a=.05 for 3 groups for power of 0.80 requires a sample of 246.) ANOVA will be conducted to determine if groups vary on stress and quality of life at baseline. Growth-curve analysis will be used to identify potential preliminary differences in the eSNAP group over time.
measure: Perceived Social Support - Quality of Life Among Participant Groups
time frame: 6 weeks per participant
description: Chi square and generalized linear model (GLM) will be used to analyze utilization of support services differences.
measure: Incidence of Clinic Disruption
time frame: 6 weeks per participant
description: Incidence of clinic disruption per participant group.
measure: Incidence of Problems with eSNAP implementation
time frame: 6 weeks per participant
description: Chi square and generalized linear model (GLM) will be used to analyze trends in satisfaction or time spent on ecomapping/eSNAP.
arm group label: Intervention - Primary Brain Tumor
description: eSNAP Intervention Plus Questionnaires: Family caregivers of primary brain tumor patients.
arm group label: Intervention - Secondary Brain Tumor
description: eSNAP Intervention Plus Questionnaires: Family caregivers of secondary brain tumor patients.
arm group label: Control - Primary Brain Tumor
description: Questionnaires Only Control: Family caregivers of primary brain tumor patients.
arm group label: Control - Secondary Brain Tumor
description: Questionnaires Only Control: Family caregivers of secondary brain tumor patients.
intervention type: Behavioral
intervention name: eSNAP
description: Participants in the intervention group will then be given a tablet loaded with the eSNAP application and asked to create a visualization of their social networks. Upon completion, participants will be asked to review their ecomaps and complete the user experience questionnaire.
arm group label: Intervention - Primary Brain Tumor
arm group label: Intervention - Secondary Brain Tumor
other name: Electronic Social Network Assessment Program
intervention type: Behavioral
intervention name: Questionnaires
description: Participants will complete demographics and baseline (T1; baseline) questionnaires. For all participants Time 2 (T2; 3 week) and Time 3 (T3; 6 week) questionnaires will be completed either by phone, mail, or email (depending on participant preference) to assess longer-term effects of eSNAP on outcomes versus controls.
arm group label: Control - Primary Brain Tumor
arm group label: Control - Secondary Brain Tumor
arm group label: Intervention - Primary Brain Tumor
arm group label: Intervention - Secondary Brain Tumor
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Maija Reblin, Ph.D.
role: Principal Investigator
affiliation: H. Lee Moffitt Cancer Center and Research Institute
facility: 
country: United States
url: https://moffitt.org/clinical-trials-research/
description: Moffitt Cancer Center Clinical Trials website
responsible party type: Sponsor
mesh term: Brain Neoplasms