<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/NCT04466592</url>
  </required_header>
  <id_info>
    <org_study_id>232050</org_study_id>
    <nct_id>NCT04466592</nct_id>
  </id_info>
  <brief_title>Health and Employment After Gastro Intestinal Surgery - HEAGIS1</brief_title>
  <acronym>HEAGIS1</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 esophagus 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 patient ability in dealing with after surgery consequences will be&#xD;
      evaluated in order to define targeted support, which will be offered by professional&#xD;
      psychologists. These interventions efficacy will be evaluated through another administration&#xD;
      of the HEADS-DQ.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 13, 2019</start_date>
  <completion_date type="Actual">April 30, 2021</completion_date>
  <primary_completion_date type="Actual">February 28, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Participants will receive the supportive intervention based on the results of the HEADS-DQ during the post operative period.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>participants' health competences</measure>
    <time_frame>9 months after the surgery</time_frame>
    <description>competences measured by HEAGIS-DQ. competences measured by HEAGIS-DQ (Health and Employment After Gastro intestinal Surgery - Dialogical Questionnaire): the questionnaire gives an evaluation of the four competences (future forethought; context evaluation; consequences of own actions forethought; use of available resources), for each of the four areas(clinical; familiar; working; daily-activities). Each competence can be &quot;low&quot;, &quot;medium&quot; or &quot;high&quot;. Best level: &quot;high level&quot;</description>
  </primary_outcome>
  <primary_outcome>
    <measure>anxiety and depression</measure>
    <time_frame>9 months after the surgery</time_frame>
    <description>HADS - Hospital Anxiety and Depression Scale measures. score range for depression: 0 - 7 Normal / 8 - 10 borderline / 11 - 17 Abnormal score range for Anxiety: 0 - 7 Normal / 8 - 10 borderline / 11 - 17 Abnormal</description>
  </primary_outcome>
  <primary_outcome>
    <measure>general quality of life</measure>
    <time_frame>9 months after the surgery</time_frame>
    <description>measured by EORTC QLQ C30 (European Organisation for Research and Treatment of Cancer - Quality of Life of Cancer patients) Role, social, emotional scales: range score for functional scale: 0 (worst) - 100 (best) Financial difficulties: range score for symptoms scale: 0 (best) - 100 (worst) Global health status: range score for global health: 0 (worst) - 100 (best)</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_arms>1</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Esophageal Neoplasms</condition>
  <condition>Stomach Neoplasm</condition>
  <condition>Colonic Neoplasms</condition>
  <arm_group>
    <arm_group_label>Supportive intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A research psychologist will support participants, promoting their competences in the recover of work and social activities, such as the compliance.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Promotion of competences of participant involved in the management of the post operative period</intervention_name>
    <description>The research psychologist will be in touch with the participants for 9 months after the surgery (weekly, biweekly or monthly) in order to help them recovering social and work activities, and dealing with the consequences of the surgery. Specifically, four competences will be promoted (future forethought; context evaluation; consequences of own actions forethought; use of available resources), each relevant to four areas (clinical; familiar; working; daily-activities).</description>
    <arm_group_label>Supportive intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt;18 years old;&#xD;
&#xD;
          -  Comprehension of Italian language;&#xD;
&#xD;
          -  Esophageal or gastro intestinal cancer diagnosis;&#xD;
&#xD;
          -  Curative surgery for neoplasm;&#xD;
&#xD;
          -  No metastasis;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt;18 years old&#xD;
&#xD;
          -  Non comprehension of Italian language;&#xD;
&#xD;
          -  No esophageal or gastro intestinal cancer diagnosis;&#xD;
&#xD;
          -  Palliative ;&#xD;
&#xD;
          -  Cancer recurrence or metastasis.&#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>Gian Piero Turchi</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Padova</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Humanitas Mirasole S.p.a.</name>
      <address>
        <city>Rozzano</city>
        <state>Milan</state>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
  </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>
  </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>September 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>January 13, 2022</last_update_submitted>
  <last_update_submitted_qc>January 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>quality of life</keyword>
  <keyword>work</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>Stomach Neoplasms</mesh_term>
    <mesh_term>Esophageal 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/NCT04466592
org study id: 232050
nct id: NCT04466592
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 esophagus 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 patient ability in dealing with after surgery consequences will be
      evaluated in order to define targeted support, which will be offered by professional
      psychologists. These interventions efficacy will be evaluated through another administration
      of the HEADS-DQ.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Participants will receive the supportive intervention based on the results of the HEADS-DQ during the post operative period.
primary purpose: Supportive Care
masking: None (Open Label)
measure: participants' health competences
time frame: 9 months after the surgery
description: competences measured by HEAGIS-DQ. competences measured by HEAGIS-DQ (Health and Employment After Gastro intestinal Surgery - Dialogical Questionnaire): the questionnaire gives an evaluation of the four competences (future forethought; context evaluation; consequences of own actions forethought; use of available resources), for each of the four areas(clinical; familiar; working; daily-activities). Each competence can be "low", "medium" or "high". Best level: "high level"
measure: anxiety and depression
time frame: 9 months after the surgery
description: HADS - Hospital Anxiety and Depression Scale measures. score range for depression: 0 - 7 Normal / 8 - 10 borderline / 11 - 17 Abnormal score range for Anxiety: 0 - 7 Normal / 8 - 10 borderline / 11 - 17 Abnormal
measure: general quality of life
time frame: 9 months after the surgery
description: measured by EORTC QLQ C30 (European Organisation for Research and Treatment of Cancer - Quality of Life of Cancer patients) Role, social, emotional scales: range score for functional scale: 0 (worst) - 100 (best) Financial difficulties: range score for symptoms scale: 0 (best) - 100 (worst) Global health status: range score for global health: 0 (worst) - 100 (best)
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: Supportive intervention
arm group type: Experimental
description: A research psychologist will support participants, promoting their competences in the recover of work and social activities, such as the compliance.
intervention type: Behavioral
intervention name: Promotion of competences of participant involved in the management of the post operative period
description: The research psychologist will be in touch with the participants for 9 months after the surgery (weekly, biweekly or monthly) in order to help them recovering social and work activities, and dealing with the consequences of the surgery. Specifically, four competences will be promoted (future forethought; context evaluation; consequences of own actions forethought; use of available resources), each relevant to four areas (clinical; familiar; working; daily-activities).
arm group label: Supportive intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gian Piero Turchi
role: Principal Investigator
affiliation: University of Padova
facility: 
facility: 
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: Stomach Neoplasms
mesh term: Esophageal Neoplasms
mesh term: Colonic Neoplasms
sharing ipd: No