xml: <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/NCT05984914</url>
    </required_header>
    <id_info>
      <org_study_id>2513</org_study_id>
      <nct_id>NCT05984914</nct_id>
    </id_info>
    <brief_title>Stress Management and Biological Age in Breast Cancer Patients.RCT</brief_title>
    <official_title>Psychological and Biological Outcomes in Breast Cancer Patients After Pythagorean Self-Awareness Intervention.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Maria Charalampopoulou</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Hippocration General Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Saint Savvas Anticancer Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Hellenic Anticancer Institute</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>National and Kapodistrian University of Athens</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>
        Intense stress has harmful effects on the body, contributing to various disorders. Breast&#xD;
        cancer patients experience a build-up of stress due to their diagnosis and treatments. Stress&#xD;
        can cause epigenetic changes in a cellular level (such as accelerated increase in biological&#xD;
        age) that may negatively affect oncological treatments.&#xD;
  &#xD;
        This study aims to investigate the effect of stress management, specifically the Pythagorean&#xD;
        Self-Awareness Intervention, on telomere length in T-leukocytes of breast cancer patients&#xD;
        after completing all treatments except hormonal therapy. The study involves self-referred&#xD;
        questionnaires, hair cortisol collection, and blood material extraction.&#xD;
  &#xD;
        Understanding the role of stress management in breast cancer may lead to improved patient&#xD;
        outcomes and survival rates.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Distress can have serious effects on the human body and is known to contribute to various&#xD;
        disorders, including cardiovascular diseases. In the case of breast cancer, patients often&#xD;
        experience a build-up of stressful events throughout their journey with the disease, such as&#xD;
        diagnosis, surgery, chemotherapy, radiotherapy, survival, and dealing with side effects of&#xD;
        anticancer therapy.&#xD;
  &#xD;
        Many studies have shown that psychological stress is closely related to increased cortisol&#xD;
        levels in the body. This stress may lead to epigenetic changes in telomere length, the action&#xD;
        of telomerase, the function of T-leukocytes, and the response of pro-inflammatory cytokines,&#xD;
        all of which play significant roles in the treatment of oncological patients.&#xD;
  &#xD;
        Considering these factors, managing stress becomes crucial, as it can not only indirectly&#xD;
        affect the disease's outcome but also impact survival. This scientific protocol aims to&#xD;
        investigate the impact of a holistic stress management program on the telomere length of&#xD;
        T-leukocytes in the peripheral blood of women diagnosed with breast cancer.&#xD;
  &#xD;
        The stress management technique to be employed is the Pythagorean Self-Awareness&#xD;
        Intervention, which will be administered only after completing all cancer treatments, except&#xD;
        for hormonal therapy. The methods that will be followed include distributing self-referred&#xD;
        questionnaires to assess stress and lifestyle, collecting hair cortisol samples, and&#xD;
        extracting genetic (DNA) material to study the telomere length of T-cells from peripheral&#xD;
        blood.&#xD;
  &#xD;
        By studying the impact of stress and its management on telomere length in breast cancer&#xD;
        patients, this study aims to contribute to a better understanding of how stress affects&#xD;
        health outcomes and potentially provide insights into improving patient care.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 4, 2021</start_date>
    <completion_date type="Anticipated">January 2024</completion_date>
    <primary_completion_date type="Anticipated">October 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Psychological I</measure>
      <time_frame>9 weeks after the 1st session</time_frame>
      <description>Perceived stress (measured by Perceived Stress Scale-14, expected decrease in mean score)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Psychological II</measure>
      <time_frame>9 weeks after the 1st session</time_frame>
      <description>Symptoms of anxiety-stress-depression (measured by Depression Anxiety Stress Scale-21, expected decrease in mean scores)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Physical I</measure>
      <time_frame>9 weeks after the 1st session</time_frame>
      <description>Telomere length (measured in mean T/S)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Physical II</measure>
      <time_frame>9 weeks after the 1st session</time_frame>
      <description>Hair cortisol levels (measured in pg/mg )</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Physical III</measure>
      <time_frame>9 weeks after the 1st session</time_frame>
      <description>Body Composition Analysis (measured in kg and %)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Psychological III</measure>
      <time_frame>9 weeks after the 1st session</time_frame>
      <description>QOL (measured by European Organization for Research and Treatment Questionnaire, expected increase in means score)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Stress</condition>
    <condition>Breast Cancer</condition>
    <condition>Telomere Length, Mean Leukocyte</condition>
    <arm_group>
      <arm_group_label>PSAI group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants are enrolled in the Pythagorean Self-Awareness Intervention (PSAI) where they receive weekly group sessions of 120 min for 8 weeks and they receive information about stress and lifestyle modifications and they are also instructed to practice the PSAI at bedtime and in the morning, every day, at home.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>One day seminar where they receive information about stress and lifestyle modifications</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>PSAI</intervention_name>
      <description>The 8 sessions included biofeedback training in diaphragmatic breathing, information about distress, its symptoms, ways to manage stress through lifestyle modifications (physical activity, principals of Mediterranean diet without alcohol consumption, sleep hygiene, diaphragmatic breathing, conflict avoidance) &amp; instructions for lymphedema prevention, introduction to the Pythagorean Self-Awareness Intervention, instructions for the implementation of the technique, analysis of the Golden Verses,and their connection with lifestyle medicine as well as active involvement of the participants with group conversation and sharing of experiences.</description>
      <arm_group_label>PSAI group</arm_group_label>
      <other_name>Pythagorean Self-Awareness Intervention</other_name>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>One day seminar</intervention_name>
      <description>The one day seminar included biofeedback training in diaphragmatic breathing, information about distress, its symptoms, ways to manage stress through lifestyle modifications (physical activity, principals of Mediterranean diet without alcohol consumption, sleep hygiene, diaphragmatic breathing, conflict avoidance) &amp; instructions for lymphedema prevention.</description>
      <arm_group_label>Control group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of primary breast cancer&#xD;
  &#xD;
            -  Completion of anticancer therapy (except for hormonal therapy)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Psychiatric diagnosis and treatment&#xD;
  &#xD;
            -  Metastasis&#xD;
  &#xD;
            -  Previous participation in any stress management and health promotion study&#xD;
  &#xD;
            -  Inability to read or write in Greek&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Flora Bacopoulou, MD,PhD</last_name>
      <role>Study Director</role>
      <affiliation>Aghia Sofia Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Maria Charalampopoulou, PT, CDT, MSc</last_name>
      <phone>+306949614342</phone>
      <email>maria.charalampopoulou@outlook.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Agios Savvas Hospital</name>
        <address>
          <city>Athens</city>
          <zip>11522</zip>
          <country>Greece</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Dimitrios Tryfonopoulos, MD,PhD</last_name>
        <phone>+306932669110</phone>
        <email>oncology2@agsavvas-hosp.grm</email>
      </contact>
      <investigator>
        <last_name>Maria Charalampopoulou, PT, CDT, MSc</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Greece</country>
    </location_countries>
    <reference>
      <citation>Chrousos GP. Stress and disorders of the stress system. Nat Rev Endocrinol. 2009 Jul;5(7):374-81. doi: 10.1038/nrendo.2009.106. Epub 2009 Jun 2.</citation>
      <PMID>19488073</PMID>
    </reference>
    <reference>
      <citation>Lin Y, Wang C, Zhong Y, Huang X, Peng L, Shan G, Wang K, Sun Q. Striking life events associated with primary breast cancer susceptibility in women: a meta-analysis study. J Exp Clin Cancer Res. 2013 Aug 13;32(1):53. doi: 10.1186/1756-9966-32-53.</citation>
      <PMID>23941600</PMID>
    </reference>
    <reference>
      <citation>Damjanovic AK, Yang Y, Glaser R, Kiecolt-Glaser JK, Nguyen H, Laskowski B, Zou Y, Beversdorf DQ, Weng NP. Accelerated telomere erosion is associated with a declining immune function of caregivers of Alzheimer's disease patients. J Immunol. 2007 Sep 15;179(6):4249-54. doi: 10.4049/jimmunol.179.6.4249.</citation>
      <PMID>17785865</PMID>
    </reference>
    <reference>
      <citation>Charalampopoulou M, Bacopoulou F, Syrigos KN, Filopoulos E, Chrousos GP, Darviri C. The effects of Pythagorean Self-Awareness Intervention on breast cancer patients undergoing adjuvant therapy: A pilot randomized controlled trial. Breast. 2020 Feb;49:210-218. doi: 10.1016/j.breast.2019.12.012. Epub 2019 Dec 20.</citation>
      <PMID>31901782</PMID>
    </reference>
    <reference>
      <citation>Carlson LE, Beattie TL, Giese-Davis J, Faris P, Tamagawa R, Fick LJ, Degelman ES, Speca M. Mindfulness-based cancer recovery and supportive-expressive therapy maintain telomere length relative to controls in distressed breast cancer survivors. Cancer. 2015 Feb 1;121(3):476-84. doi: 10.1002/cncr.29063. Epub 2014 Nov 3.</citation>
      <PMID>25367403</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>National and Kapodistrian University of Athens</investigator_affiliation>
      <investigator_full_name>Maria Charalampopoulou</investigator_full_name>
      <investigator_title>PhD candidate</investigator_title>
    </responsible_party>
    <keyword>Stress</keyword>
    <keyword>Breast Cancer</keyword>
    <keyword>Lifestyle</keyword>
    <keyword>Stress management</keyword>
    <keyword>Telomeres</keyword>
    <keyword>Biological age</keyword>
    <keyword>PSAI</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Breast Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>All IPD that underlie results in a publication</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>After publication of the study</ipd_time_frame>
      <ipd_access_criteria>On request</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05984914
  org study id: 2513
  nct id: NCT05984914
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Intense stress has harmful effects on the body, contributing to various disorders. Breast
        cancer patients experience a build-up of stress due to their diagnosis and treatments. Stress
        can cause epigenetic changes in a cellular level (such as accelerated increase in biological
        age) that may negatively affect oncological treatments.
  
        This study aims to investigate the effect of stress management, specifically the Pythagorean
        Self-Awareness Intervention, on telomere length in T-leukocytes of breast cancer patients
        after completing all treatments except hormonal therapy. The study involves self-referred
        questionnaires, hair cortisol collection, and blood material extraction.
  
        Understanding the role of stress management in breast cancer may lead to improved patient
        outcomes and survival rates.
  Distress can have serious effects on the human body and is known to contribute to various
        disorders, including cardiovascular diseases. In the case of breast cancer, patients often
        experience a build-up of stressful events throughout their journey with the disease, such as
        diagnosis, surgery, chemotherapy, radiotherapy, survival, and dealing with side effects of
        anticancer therapy.
  
        Many studies have shown that psychological stress is closely related to increased cortisol
        levels in the body. This stress may lead to epigenetic changes in telomere length, the action
        of telomerase, the function of T-leukocytes, and the response of pro-inflammatory cytokines,
        all of which play significant roles in the treatment of oncological patients.
  
        Considering these factors, managing stress becomes crucial, as it can not only indirectly
        affect the disease's outcome but also impact survival. This scientific protocol aims to
        investigate the impact of a holistic stress management program on the telomere length of
        T-leukocytes in the peripheral blood of women diagnosed with breast cancer.
  
        The stress management technique to be employed is the Pythagorean Self-Awareness
        Intervention, which will be administered only after completing all cancer treatments, except
        for hormonal therapy. The methods that will be followed include distributing self-referred
        questionnaires to assess stress and lifestyle, collecting hair cortisol samples, and
        extracting genetic (DNA) material to study the telomere length of T-cells from peripheral
        blood.
  
        By studying the impact of stress and its management on telomere length in breast cancer
        patients, this study aims to contribute to a better understanding of how stress affects
        health outcomes and potentially provide insights into improving patient care.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Psychological I
  time frame: 9 weeks after the 1st session
  description: Perceived stress (measured by Perceived Stress Scale-14, expected decrease in mean score)
  measure: Psychological II
  time frame: 9 weeks after the 1st session
  description: Symptoms of anxiety-stress-depression (measured by Depression Anxiety Stress Scale-21, expected decrease in mean scores)
  measure: Physical I
  time frame: 9 weeks after the 1st session
  description: Telomere length (measured in mean T/S)
  measure: Physical II
  time frame: 9 weeks after the 1st session
  description: Hair cortisol levels (measured in pg/mg )
  measure: Physical III
  time frame: 9 weeks after the 1st session
  description: Body Composition Analysis (measured in kg and %)
  measure: Psychological III
  time frame: 9 weeks after the 1st session
  description: QOL (measured by European Organization for Research and Treatment Questionnaire, expected increase in means score)
  arm group label: PSAI group
  arm group type: Experimental
  description: Participants are enrolled in the Pythagorean Self-Awareness Intervention (PSAI) where they receive weekly group sessions of 120 min for 8 weeks and they receive information about stress and lifestyle modifications and they are also instructed to practice the PSAI at bedtime and in the morning, every day, at home.
  arm group label: Control group
  arm group type: Active Comparator
  description: One day seminar where they receive information about stress and lifestyle modifications
  intervention type: Behavioral
  intervention name: PSAI
  description: The 8 sessions included biofeedback training in diaphragmatic breathing, information about distress, its symptoms, ways to manage stress through lifestyle modifications (physical activity, principals of Mediterranean diet without alcohol consumption, sleep hygiene, diaphragmatic breathing, conflict avoidance) & instructions for lymphedema prevention, introduction to the Pythagorean Self-Awareness Intervention, instructions for the implementation of the technique, analysis of the Golden Verses,and their connection with lifestyle medicine as well as active involvement of the participants with group conversation and sharing of experiences.
  arm group label: PSAI group
  other name: Pythagorean Self-Awareness Intervention
  intervention type: Behavioral
  intervention name: One day seminar
  description: The one day seminar included biofeedback training in diaphragmatic breathing, information about distress, its symptoms, ways to manage stress through lifestyle modifications (physical activity, principals of Mediterranean diet without alcohol consumption, sleep hygiene, diaphragmatic breathing, conflict avoidance) & instructions for lymphedema prevention.
  arm group label: Control group
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Flora Bacopoulou, MD,PhD
  role: Study Director
  affiliation: Aghia Sofia Hospital
  last name: Maria Charalampopoulou, PT, CDT, MSc
  phone: +306949614342
  email: maria.charalampopoulou@outlook.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Greece
  citation: Chrousos GP. Stress and disorders of the stress system. Nat Rev Endocrinol. 2009 Jul;5(7):374-81. doi: 10.1038/nrendo.2009.106. Epub 2009 Jun 2.
  PMID: 19488073
  citation: Lin Y, Wang C, Zhong Y, Huang X, Peng L, Shan G, Wang K, Sun Q. Striking life events associated with primary breast cancer susceptibility in women: a meta-analysis study. J Exp Clin Cancer Res. 2013 Aug 13;32(1):53. doi: 10.1186/1756-9966-32-53.
  PMID: 23941600
  citation: Damjanovic AK, Yang Y, Glaser R, Kiecolt-Glaser JK, Nguyen H, Laskowski B, Zou Y, Beversdorf DQ, Weng NP. Accelerated telomere erosion is associated with a declining immune function of caregivers of Alzheimer's disease patients. J Immunol. 2007 Sep 15;179(6):4249-54. doi: 10.4049/jimmunol.179.6.4249.
  PMID: 17785865
  citation: Charalampopoulou M, Bacopoulou F, Syrigos KN, Filopoulos E, Chrousos GP, Darviri C. The effects of Pythagorean Self-Awareness Intervention on breast cancer patients undergoing adjuvant therapy: A pilot randomized controlled trial. Breast. 2020 Feb;49:210-218. doi: 10.1016/j.breast.2019.12.012. Epub 2019 Dec 20.
  PMID: 31901782
  citation: Carlson LE, Beattie TL, Giese-Davis J, Faris P, Tamagawa R, Fick LJ, Degelman ES, Speca M. Mindfulness-based cancer recovery and supportive-expressive therapy maintain telomere length relative to controls in distressed breast cancer survivors. Cancer. 2015 Feb 1;121(3):476-84. doi: 10.1002/cncr.29063. Epub 2014 Nov 3.
  PMID: 25367403
  responsible party type: Sponsor-Investigator
  investigator affiliation: National and Kapodistrian University of Athens
  investigator full name: Maria Charalampopoulou
  investigator title: PhD candidate
  mesh term: Breast Neoplasms
  sharing ipd: Yes
  ipd description: All IPD that underlie results in a publication
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: After publication of the study
  ipd access criteria: On request