<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/NCT04466631</url>
  </required_header>
  <id_info>
    <org_study_id>232050b</org_study_id>
    <nct_id>NCT04466631</nct_id>
  </id_info>
  <brief_title>Health and Employment After Gastro Intestinal Surgery - HEAGIS2</brief_title>
  <acronym>HEAGIS2</acronym>
  <official_title>SAlute e LaVoro in Chirurgia Oncologica (SALVO)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Padova</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Humanitas Hospital, Italy</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Istituto Oncologico Veneto IRCCS</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Padova</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>
      By using the M.A.D.I.T. methodology and the Dialogics science, SALVO Project aims to develop&#xD;
      operational guidelines to support oncological target patients in the resumption of their&#xD;
      daily post-operative activities. The research will implement an instrument for the purpose of&#xD;
      measuring the health need of participants who are admitted to the surgical ward. Therefore,&#xD;
      targeted interventions will be implemented with participants, and efficacy will be evaluated&#xD;
      in order to define treatment guidelines.&#xD;
&#xD;
      The principal aim of this study is to create a validated and replicable intervention model&#xD;
      for supporting patients who undergone surgery for esophageal and gastro intestinal cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Several studies highlight how patients diagnosed with a digestive tract cancer, experience&#xD;
      difficulties in returning to work after treatment, leading to socio-economic spill-over&#xD;
      effects.&#xD;
&#xD;
      A specific 16 questions questionnaire had been developed for this study, the &quot;Health and&#xD;
      Employment After Gastro Intestinal Surgery Dialogical Questionnaire&quot; (HEADS-DQ). It&#xD;
      investigate peculiar patient competences involved after surgery: future forethought; context&#xD;
      evaluation; consequences of own actions forethought; use of available resources, each&#xD;
      relevant to four areas: clinical; familiar; working; daily-activities.&#xD;
&#xD;
      Through this questionnaire participants ability in dealing with after surgery consequences&#xD;
      will be evaluated in order to describe their development during the post surgery period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 15, 2020</start_date>
  <completion_date type="Anticipated">April 2021</completion_date>
  <primary_completion_date type="Anticipated">April 2021</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>Utilization of specific competences by participants</measure>
    <time_frame>9 months after the surgery</time_frame>
    <description>Textual data derived from textual analysis: future forethought; context evaluation; consequences of own actions forethought; use of available resources, each relevant to four areas: clinical; familiar; working; daily-activities</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants maintaining their job</measure>
    <time_frame>9 months after the surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with jejunostomy maintaining their job</measure>
    <time_frame>9 months after the surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants maintaining their social activities</measure>
    <time_frame>9 months after the surgery</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Esophageal Neoplasms</condition>
  <condition>Gastric Neoplasm</condition>
  <condition>Colon Neoplasms</condition>
  <arm_group>
    <arm_group_label>Observative longitudinal</arm_group_label>
    <description>The participants won't receive any support during the post surgery period.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergone surgery for esophagus or gastrointestinal cancer.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt;18 years old;&#xD;
&#xD;
          -  Comprehension of Italian language;&#xD;
&#xD;
          -  Esophageal or gastrointestinal cancer diagnosis;&#xD;
&#xD;
          -  Curative surgery;&#xD;
&#xD;
          -  No metastasis or neoplasm recurrence.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt;18 years old;&#xD;
&#xD;
          -  No comprehension of Italian language;&#xD;
&#xD;
          -  Not esophageal or gastrointestinal cancer diagnosis;&#xD;
&#xD;
          -  Palliative surgery;&#xD;
&#xD;
          -  Metastasis or neoplasm recurrence.&#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_contact>
    <last_name>Gian Piero Turchi</last_name>
    <phone>+39 0498276633</phone>
    <email>gianpiero.turchi@unipd.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Alessandro Fabbian</last_name>
    <phone>+393481492867</phone>
    <email>alessandro.fabbian@unipd.it</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Humanitas Mirasole S.p.a.</name>
      <address>
        <city>Rozzano</city>
        <state>Milan</state>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Istituto Oncologico Veneto - IOV IRCSS</name>
      <address>
        <city>Castelfranco Veneto</city>
        <state>Treviso</state>
        <zip>31033</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>De Blasi G, Bouteyre E, Rollin L. Giving up work after cancer: An exploratory qualitative study of three clinical cases. Work. 2018;60(1):105-115. doi: 10.3233/WOR-182712.</citation>
    <PMID>29733033</PMID>
  </reference>
  <reference>
    <citation>Moran JR, Short PF, Hollenbeak CS. Long-term employment effects of surviving cancer. J Health Econ. 2011 May;30(3):505-14. doi: 10.1016/j.jhealeco.2011.02.001. Epub 2011 Mar 1.</citation>
    <PMID>21429606</PMID>
  </reference>
  <reference>
    <citation>Yarker J, Munir F, Bains M, Kalawsky K, Haslam C. The role of communication and support in return to work following cancer-related absence. Psychooncology. 2010 Oct;19(10):1078-85. doi: 10.1002/pon.1662.</citation>
    <PMID>20014202</PMID>
  </reference>
  <reference>
    <citation>Parsons JA, Eakin JM, Bell RS, Franche RL, Davis AM. &quot;So, are you back to work yet?&quot; Re-conceptualizing 'work' and 'return to work' in the context of primary bone cancer. Soc Sci Med. 2008 Dec;67(11):1826-36. doi: 10.1016/j.socscimed.2008.09.011. Epub 2008 Oct 11.</citation>
    <PMID>18851893</PMID>
  </reference>
  <reference>
    <citation>Mehnert A. Employment and work-related issues in cancer survivors. Crit Rev Oncol Hematol. 2011 Feb;77(2):109-30. doi: 10.1016/j.critrevonc.2010.01.004. Epub 2010 Feb 8.</citation>
    <PMID>20117019</PMID>
  </reference>
  <reference>
    <citation>Pinto E, Cavallin F, Alfieri R, Saadeh LM, Mantoan S, Cagol M, Castoro C, Scarpa M. Impact of esophagectomy for cancer on patients' occupational status. Eur J Surg Oncol. 2016 Jan;42(1):103-9. doi: 10.1016/j.ejso.2015.09.021. Epub 2015 Oct 9.</citation>
    <PMID>26482347</PMID>
  </reference>
  <reference>
    <citation>Martinez LR, White CD, Shapiro JR, Hebl MR. Selection BIAS: Stereotypes and discrimination related to having a history of cancer. J Appl Psychol. 2016 Jan;101(1):122-8. doi: 10.1037/apl0000036. Epub 2015 Jun 29.</citation>
    <PMID>26121089</PMID>
  </reference>
  <reference>
    <citation>Clarke TC, Christ SL, Soler-Vila H, Lee DJ, Arheart KL, Prado G, Caban-Martinez A, Fleming LE. Working with cancer: health and employment among cancer survivors. Ann Epidemiol. 2015 Nov;25(11):832-8. doi: 10.1016/j.annepidem.2015.07.011. Epub 2015 Aug 4. Erratum In: Ann Epidemiol. 2016 Jul;26(7):520.</citation>
    <PMID>26320705</PMID>
  </reference>
  <reference>
    <citation>Turchi GP, Iudici A, Faccio E. From Suicide Due to an Economic-Financial Crisis to the Management of Entrepreneurial Health: Elements of a Biographical Change Management Service and Clinical Implications. Front Psychol. 2019 Mar 4;10:426. doi: 10.3389/fpsyg.2019.00426. eCollection 2019. No abstract available.</citation>
    <PMID>30886599</PMID>
  </reference>
  <reference>
    <citation>Iudici A, Favaretto G, Turchi GP. Community perspective: How volunteers, professionals, families and the general population construct disability: Social, clinical and health implications. Disabil Health J. 2019 Apr;12(2):171-179. doi: 10.1016/j.dhjo.2018.11.014. Epub 2018 Nov 29.</citation>
    <PMID>30528178</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>July 7, 2020</last_update_submitted>
  <last_update_submitted_qc>July 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>quality of life</keyword>
  <keyword>employment</keyword>
  <keyword>social activities</keyword>
  <keyword>surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Esophageal Neoplasms</mesh_term>
    <mesh_term>Stomach Neoplasms</mesh_term>
    <mesh_term>Colonic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04466631
org study id: 232050b
nct id: NCT04466631
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
By using the M.A.D.I.T. methodology and the Dialogics science, SALVO Project aims to develop
      operational guidelines to support oncological target patients in the resumption of their
      daily post-operative activities. The research will implement an instrument for the purpose of
      measuring the health need of participants who are admitted to the surgical ward. Therefore,
      targeted interventions will be implemented with participants, and efficacy will be evaluated
      in order to define treatment guidelines.

      The principal aim of this study is to create a validated and replicable intervention model
      for supporting patients who undergone surgery for esophageal and gastro intestinal cancer.
Several studies highlight how patients diagnosed with a digestive tract cancer, experience
      difficulties in returning to work after treatment, leading to socio-economic spill-over
      effects.

      A specific 16 questions questionnaire had been developed for this study, the "Health and
      Employment After Gastro Intestinal Surgery Dialogical Questionnaire" (HEADS-DQ). It
      investigate peculiar patient competences involved after surgery: future forethought; context
      evaluation; consequences of own actions forethought; use of available resources, each
      relevant to four areas: clinical; familiar; working; daily-activities.

      Through this questionnaire participants ability in dealing with after surgery consequences
      will be evaluated in order to describe their development during the post surgery period.
observational model: Case-Only
time perspective: Prospective
measure: Utilization of specific competences by participants
time frame: 9 months after the surgery
description: Textual data derived from textual analysis: future forethought; context evaluation; consequences of own actions forethought; use of available resources, each relevant to four areas: clinical; familiar; working; daily-activities
measure: Number of participants maintaining their job
time frame: 9 months after the surgery
measure: Number of participants with jejunostomy maintaining their job
time frame: 9 months after the surgery
measure: Number of participants maintaining their social activities
time frame: 9 months after the surgery
arm group label: Observative longitudinal
description: The participants won't receive any support during the post surgery period.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gian Piero Turchi
phone: +39 0498276633
email: gianpiero.turchi@unipd.it
last name: Alessandro Fabbian
phone: +393481492867
email: alessandro.fabbian@unipd.it
facility: 
status: Recruiting
facility: 
status: Recruiting
country: Italy
citation: De Blasi G, Bouteyre E, Rollin L. Giving up work after cancer: An exploratory qualitative study of three clinical cases. Work. 2018;60(1):105-115. doi: 10.3233/WOR-182712.
PMID: 29733033
citation: Moran JR, Short PF, Hollenbeak CS. Long-term employment effects of surviving cancer. J Health Econ. 2011 May;30(3):505-14. doi: 10.1016/j.jhealeco.2011.02.001. Epub 2011 Mar 1.
PMID: 21429606
citation: Yarker J, Munir F, Bains M, Kalawsky K, Haslam C. The role of communication and support in return to work following cancer-related absence. Psychooncology. 2010 Oct;19(10):1078-85. doi: 10.1002/pon.1662.
PMID: 20014202
citation: Parsons JA, Eakin JM, Bell RS, Franche RL, Davis AM. "So, are you back to work yet?" Re-conceptualizing 'work' and 'return to work' in the context of primary bone cancer. Soc Sci Med. 2008 Dec;67(11):1826-36. doi: 10.1016/j.socscimed.2008.09.011. Epub 2008 Oct 11.
PMID: 18851893
citation: Mehnert A. Employment and work-related issues in cancer survivors. Crit Rev Oncol Hematol. 2011 Feb;77(2):109-30. doi: 10.1016/j.critrevonc.2010.01.004. Epub 2010 Feb 8.
PMID: 20117019
citation: Pinto E, Cavallin F, Alfieri R, Saadeh LM, Mantoan S, Cagol M, Castoro C, Scarpa M. Impact of esophagectomy for cancer on patients' occupational status. Eur J Surg Oncol. 2016 Jan;42(1):103-9. doi: 10.1016/j.ejso.2015.09.021. Epub 2015 Oct 9.
PMID: 26482347
citation: Martinez LR, White CD, Shapiro JR, Hebl MR. Selection BIAS: Stereotypes and discrimination related to having a history of cancer. J Appl Psychol. 2016 Jan;101(1):122-8. doi: 10.1037/apl0000036. Epub 2015 Jun 29.
PMID: 26121089
citation: Clarke TC, Christ SL, Soler-Vila H, Lee DJ, Arheart KL, Prado G, Caban-Martinez A, Fleming LE. Working with cancer: health and employment among cancer survivors. Ann Epidemiol. 2015 Nov;25(11):832-8. doi: 10.1016/j.annepidem.2015.07.011. Epub 2015 Aug 4. Erratum In: Ann Epidemiol. 2016 Jul;26(7):520.
PMID: 26320705
citation: Turchi GP, Iudici A, Faccio E. From Suicide Due to an Economic-Financial Crisis to the Management of Entrepreneurial Health: Elements of a Biographical Change Management Service and Clinical Implications. Front Psychol. 2019 Mar 4;10:426. doi: 10.3389/fpsyg.2019.00426. eCollection 2019. No abstract available.
PMID: 30886599
citation: Iudici A, Favaretto G, Turchi GP. Community perspective: How volunteers, professionals, families and the general population construct disability: Social, clinical and health implications. Disabil Health J. 2019 Apr;12(2):171-179. doi: 10.1016/j.dhjo.2018.11.014. Epub 2018 Nov 29.
PMID: 30528178
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Esophageal Neoplasms
mesh term: Stomach Neoplasms
mesh term: Colonic Neoplasms
sharing ipd: No