<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/NCT03781193</url>
  </required_header>
  <id_info>
    <org_study_id>1945</org_study_id>
    <nct_id>NCT03781193</nct_id>
  </id_info>
  <brief_title>Psychological Predictors in Colorectal Cancer Surgery Recovery</brief_title>
  <acronym>MIND</acronym>
  <official_title>Psychological Predictors of Post-surgical Recovery in Colorectal Cancer Patients: a Pilot Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istituto Clinico Humanitas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istituto Clinico Humanitas</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>
      This is an observation pilot trial aimed to study to the association between mindfulness and&#xD;
      other psychological factors, including both protective and risk factors, with recovery of&#xD;
      functional ability following colorectal cancer surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Preliminary evidence suggests that there are multiple variables that may influence the&#xD;
      functional recovery following colorectal cancer surgery, some of which deal with the&#xD;
      psychological domain. Distress and depression can negatively affect the perceptions of&#xD;
      functional ability, while resilience and effective coping styles promote a better&#xD;
      psychological adaptation to challenging situations. Furthermore, psychosocial prehabilitation&#xD;
      and interventions have been proposed as a feasible and cost-effective way to positively&#xD;
      influence the recovery after surgery in association with the Enhanced Recovery After Surgery&#xD;
      (ERAS) protocol.&#xD;
&#xD;
      In particular, mindfulness is proved to be associated with higher quality of life in&#xD;
      different medical conditions, including oncological patients and has been also associated&#xD;
      with improved clinical outcomes.&#xD;
&#xD;
      The aim of the study is to investigate the association of mindfulness and other psychological&#xD;
      predictors with functional and quality of life outcomes in patients undergoing colorectal&#xD;
      surgery for oncological condition.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 6, 2018</start_date>
  <completion_date type="Anticipated">July 6, 2019</completion_date>
  <primary_completion_date type="Anticipated">March 6, 2019</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>Correlation between psychological predictors questionnaires outcome and length of hospital stay</measure>
    <time_frame>Post-operative day 7</time_frame>
    <description>Length of stay calculated in days from the day of surgery until the day of discharge</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlation between psychological predictors questionnaires outcome and quality of life</measure>
    <time_frame>Post-operative day 90</time_frame>
    <description>Quality of Life will be assessed by using the European Organization for Research and Treatment of Cancer Quality of Life core Questionnaire (EORTC-QLQ-C30) and the European Organisation for Research and Treatment of Cancer Quality of life Questionnaire ColoRectal specific module (EORTC-QLQ-CR29)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlation between psychological predictors questionnaires outcome and quality of life</measure>
    <time_frame>Post-operative month 6</time_frame>
    <description>Quality of Life will be assessed by using the European Organization for Research and Treatment of Cancer quality of Life core Questionnaire (EORTC-QLQ-C30) and the European Organisation for Research and Treatment of Cancer Quality of life Questionnaire ColoRectal specific module (EORTC-QLQ-CR29)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlation between psychological predictors questionnaires outcome and quality of life</measure>
    <time_frame>Post-operative month 12</time_frame>
    <description>Quality of Life will be assessed by using the European Organization for Research and Treatment of Cancer Quality of Life core Questionnaire (EORTC-QLQ-C30) and the European Organisation for Research and Treatment of Cancer Quality of life Questionnaire ColoRectal specific module (EORTC-QLQ-CR29)</description>
  </primary_outcome>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Colorectal Cancer</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaires administration</intervention_name>
    <description>Psychological and quality of life questionnaires</description>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Five Facet Mindfulness Questionnaire (FFMQ)</intervention_name>
    <description>FFMQ is a 39-item measure consisting of five subscales (observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience).</description>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Langer Mindfulness Scale (LMS)</intervention_name>
    <description>The LMS Tis a 21-item questionnaire, assessing four domains associated with mindful thinking: novelty-seeking, engagement, novelty producing, and flexibility.</description>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cognitive Flexibility Scale (CFS)</intervention_name>
    <description>The CFS is 12-item self-report test assessing awareness.</description>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Life Orientation Test (LOT)</intervention_name>
    <description>The LOT is a 10-item, self-administered scale assessing generalized expectancies for positive versus negative outcomes.</description>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mini Locus of Control test (MLS)</intervention_name>
    <description>The MLS is a 6-item questionnaire that includes 3 factors : chance, powerful others, and internality.</description>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hospital Anxiety and Depression Scale (HADS)</intervention_name>
    <description>The HADS is a 14-items rated on a four-point Likert scale. The questionnaire was designed to screen for the presence and severity of depression (HADS-D) and anxiety (HADS-A) in people with a physical symptomatology</description>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Perceived Stress Scale (PSS)</intervention_name>
    <description>The PSS is 14-item self-report tool commonly used to provide a global measure of perceived stress in daily life.</description>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Toronto Alexithymia Scale (TAS)</intervention_name>
    <description>The TSA is a 20-item scale that evaluates the three components of alexithymia: difficulty to identify feelings and distinguish between feelings and bodily sensations of emotional arousal difficulty, describing feelings to others, and a cognitive style that is literal, utilitarian, and externally oriented.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Colorectal cancer patients scheduled for elective curative colorectal surgery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients &gt; 18 years old (both males and females).&#xD;
&#xD;
          -  Patients diagnosed with colorectal cancer.&#xD;
&#xD;
          -  Patients scheduled for elective open or laparoscopic surgery for curative intent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients unable to give the written informed consent.&#xD;
&#xD;
          -  Patients &lt; 18 years old.&#xD;
&#xD;
          -  Patients undergoing surgery in emergency setting.&#xD;
&#xD;
          -  Patients with pre-operative evidence of metastatic cancer or colorectal cancer&#xD;
             recurrence.&#xD;
&#xD;
          -  Pregnant or breastfeeding patients.&#xD;
&#xD;
          -  Any condition that, in the opinion of the investigator, can interfere with the study&#xD;
             protocol (e.g. neuropsychiatric disorders or dementia).&#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>Antonino Spinelli, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Istituto Clinico Humanitas</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Annalisa Maroli, PhD</last_name>
    <phone>+.39 02 8224 7776</phone>
    <email>annalisa.maroli@humanitas.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Francesca De Lucia, MD</last_name>
    <phone>+39 028224 7776</phone>
    <email>francesca.delucia@humanitas.it</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>IRCCS Istituto Clinico Humanitas, Division of Colon and Rectal Surgery</name>
      <address>
        <city>Milan</city>
        <state>MI</state>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Annalisa Maroli, PhD</last_name>
      <phone>0282247776</phone>
      <email>annalisa.maroli@humanitas.it</email>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>December 19, 2018</last_update_submitted>
  <last_update_submitted_qc>December 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>mindfulness</keyword>
  <keyword>Psychological predictors</keyword>
  <keyword>Colorectal surgery</keyword>
  <keyword>ERAS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal 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/NCT03781193
org study id: 1945
nct id: NCT03781193
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is an observation pilot trial aimed to study to the association between mindfulness and
      other psychological factors, including both protective and risk factors, with recovery of
      functional ability following colorectal cancer surgery.
Preliminary evidence suggests that there are multiple variables that may influence the
      functional recovery following colorectal cancer surgery, some of which deal with the
      psychological domain. Distress and depression can negatively affect the perceptions of
      functional ability, while resilience and effective coping styles promote a better
      psychological adaptation to challenging situations. Furthermore, psychosocial prehabilitation
      and interventions have been proposed as a feasible and cost-effective way to positively
      influence the recovery after surgery in association with the Enhanced Recovery After Surgery
      (ERAS) protocol.

      In particular, mindfulness is proved to be associated with higher quality of life in
      different medical conditions, including oncological patients and has been also associated
      with improved clinical outcomes.

      The aim of the study is to investigate the association of mindfulness and other psychological
      predictors with functional and quality of life outcomes in patients undergoing colorectal
      surgery for oncological condition.
observational model: Cohort
time perspective: Prospective
measure: Correlation between psychological predictors questionnaires outcome and length of hospital stay
time frame: Post-operative day 7
description: Length of stay calculated in days from the day of surgery until the day of discharge
measure: Correlation between psychological predictors questionnaires outcome and quality of life
time frame: Post-operative day 90
description: Quality of Life will be assessed by using the European Organization for Research and Treatment of Cancer Quality of Life core Questionnaire (EORTC-QLQ-C30) and the European Organisation for Research and Treatment of Cancer Quality of life Questionnaire ColoRectal specific module (EORTC-QLQ-CR29)
measure: Correlation between psychological predictors questionnaires outcome and quality of life
time frame: Post-operative month 6
description: Quality of Life will be assessed by using the European Organization for Research and Treatment of Cancer quality of Life core Questionnaire (EORTC-QLQ-C30) and the European Organisation for Research and Treatment of Cancer Quality of life Questionnaire ColoRectal specific module (EORTC-QLQ-CR29)
measure: Correlation between psychological predictors questionnaires outcome and quality of life
time frame: Post-operative month 12
description: Quality of Life will be assessed by using the European Organization for Research and Treatment of Cancer Quality of Life core Questionnaire (EORTC-QLQ-C30) and the European Organisation for Research and Treatment of Cancer Quality of life Questionnaire ColoRectal specific module (EORTC-QLQ-CR29)
intervention type: Other
intervention name: Questionnaires administration
description: Psychological and quality of life questionnaires
intervention type: Other
intervention name: Five Facet Mindfulness Questionnaire (FFMQ)
description: FFMQ is a 39-item measure consisting of five subscales (observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience).
intervention type: Other
intervention name: Langer Mindfulness Scale (LMS)
description: The LMS Tis a 21-item questionnaire, assessing four domains associated with mindful thinking: novelty-seeking, engagement, novelty producing, and flexibility.
intervention type: Other
intervention name: Cognitive Flexibility Scale (CFS)
description: The CFS is 12-item self-report test assessing awareness.
intervention type: Other
intervention name: Life Orientation Test (LOT)
description: The LOT is a 10-item, self-administered scale assessing generalized expectancies for positive versus negative outcomes.
intervention type: Other
intervention name: Mini Locus of Control test (MLS)
description: The MLS is a 6-item questionnaire that includes 3 factors : chance, powerful others, and internality.
intervention type: Other
intervention name: Hospital Anxiety and Depression Scale (HADS)
description: The HADS is a 14-items rated on a four-point Likert scale. The questionnaire was designed to screen for the presence and severity of depression (HADS-D) and anxiety (HADS-A) in people with a physical symptomatology
intervention type: Other
intervention name: Perceived Stress Scale (PSS)
description: The PSS is 14-item self-report tool commonly used to provide a global measure of perceived stress in daily life.
intervention type: Other
intervention name: Toronto Alexithymia Scale (TAS)
description: The TSA is a 20-item scale that evaluates the three components of alexithymia: difficulty to identify feelings and distinguish between feelings and bodily sensations of emotional arousal difficulty, describing feelings to others, and a cognitive style that is literal, utilitarian, and externally oriented.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Antonino Spinelli, MD, PhD
role: Principal Investigator
affiliation: Istituto Clinico Humanitas
last name: Annalisa Maroli, PhD
phone: +.39 02 8224 7776
email: annalisa.maroli@humanitas.it
last name: Francesca De Lucia, MD
phone: +39 028224 7776
email: francesca.delucia@humanitas.it
facility: 
status: Recruiting
contact: 
country: Italy
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
sharing ipd: No