<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/NCT04428710</url>
  </required_header>
  <id_info>
    <org_study_id>Cancer Genetic Counseling.PSI</org_study_id>
    <nct_id>NCT04428710</nct_id>
  </id_info>
  <brief_title>Assessment Psychological Distress for Cancer Heredity Test</brief_title>
  <official_title>Cancer Genetic Counseling and Emotional Response in Spanish Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Universitario La Fe</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Universitario La Fe</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 study of hereditary cancer related syndromes allows reducing the risk of suffering in&#xD;
      cancer to patients and close relatives. The objective of this study will be to evaluate the&#xD;
      prevelance of psychological morbidity in patients attended at cancer genetic counselling&#xD;
      unit, and to determine the socio-demographic and clinical factors that influence it.&#xD;
&#xD;
      A descriptive cross-sectional study will be carried out. Patients attented at the cancer&#xD;
      genetic counselling unit, who have criteria for conducting a genetic syndrome test related to&#xD;
      hererditary cancer, will be consecutively evaluated.&#xD;
&#xD;
      To knowing the psychological morbidity it is relevant to providing care for these patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Nowadays several familial cancer syndromes that confer a high lifetime risk of cancer can be&#xD;
      identified with genetic testing. The psychological impact of genetic testing and the rates of&#xD;
      psychological distress in patients undergoing genetic testing vary between 6 to 65% depending&#xD;
      on socio-demographic or clinical characteristics.&#xD;
&#xD;
      The effect of baseline distress on post-testing assessments tended to decrease or show little&#xD;
      change over time, it may be important to target patients with high baseline distress for&#xD;
      additional counseling or intervention both pre-testing and over time.The most robust&#xD;
      predictor of future distress is baseline distress, additional factors were associated with&#xD;
      cancer risk perception considering family history of cancer, patient's affected or unaffected&#xD;
      with cancer, etc...&#xD;
&#xD;
      It is relevant to developing and providing care for these patients, it has been demonstrated&#xD;
      that enhanced genetic counseling with clinical psychologist to facilitate decision-making&#xD;
      process, managing family concerns promoting their communication with and involvement of&#xD;
      family members, and attending their emotional distress, can be beneficial. Also, cancer&#xD;
      genetic counseling may promote patient use of personal resources and enhance patient health&#xD;
      literacy about their syndrome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>To determinate the prevalence of psychological distress of patients studied of the different hereditary cancer syndromes attended at Cancer Genetic Counseling Unit</measure>
    <time_frame>Data collection for two years</time_frame>
    <description>The Hospital Anxiety and Depression Scale (HADS), it is consisting of two subscales with seven items respectively, anxiety (HADS-A) and depression (HADS-D) symptomatology. The questionnaire is used to evaluate psychological distress in non-psychiatric settings. In general medical outpatients the optimal cut-off point for the screening for psychiatric morbidity seems to be 12, for screening depressive symptomatology seems to be 5 score and 8 (range 7-10) for screening anxiety symptomatology. In Spanish population the HADS demonstrated a good internal consistency and optimal psychometric properties.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To determinate cáncer worry of patients studied of the different hereditary cancer syndromes attended at Cancer Genetic Counseling Unit</measure>
    <time_frame>Data collection for two years</time_frame>
    <description>Cancer Worry Scale. (CWS), consists of the six-item scale measures concerns about developing cancer, and the impact of these concerns on performing daily tasks among patients at risk for hereditary cancer. The questionnaire are rated on a 4-point Likert scale ranging from &quot;never&quot; to &quot;almost always&quot;, with a total value ranging from 6 (minimal worry) to 24 (maximum worry). CWS presented good reliability coefficient in Spanish samples at risk for hereditary cancer.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To determinate the prevalence of psychological morbidity of patients studied of the different hereditary cancer syndromes attended at Cancer Genetic Counseling Unit</measure>
    <time_frame>Data collection for two years</time_frame>
    <description>The General Health Questionnaire (GHQ-28), measures psychological distress, which is consisting of social functioning, somatic symptoms, anxiety/sleep disturbances, and depression. Each item was scored from 0 to 3. Higher scores indicating greater psychological morbidity, with a cutting score of 5/6 to identify psychiatric morbidity. The Spanish version of the GHQ-28 had adequate psychometric properties.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Find out differences on psychological distress regarding the hereditary syndrome studied at the cancer genetic counseling.</measure>
    <time_frame>Data collection for two years</time_frame>
    <description>Psychometric questionnaire. Hospital Anxiety and Depresion Scale (HADS) , it is consisting of two subscales with seven items respectively, anxiety (HADS-A) and depression (HADS-D) symptomatology. The questionnaire is used to evaluate psychological distress in non-psychiatric settings. The optimal cut-off point for screening psychiatric morbidity seems to be 12, for screening depressive symptomatology seems to be 5 score and 8 (range 7-10) score for screening anxiety symptomatology. In Spanish population the HADS demonstrated a good internal consistency and optimal psychometric properties.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Identify differences in cancer worry regarding the hereditary syndrome studied at the cancer genetic counseling.</measure>
    <time_frame>Data collection for two years</time_frame>
    <description>Cancer Worry Scale (CWS). this questionnaire consists of the six-item measures concerns about developing cancer and the impact of these concerns on performing daily tasks among patients at risk for hereditary cancer. The questionnaire are rated on a 4-point Likert scale ranging from &quot;never&quot; to &quot;almost always&quot;, with a total value ranging from 6 (minimal worry) to 24 (maximum worry). CWS presented good reliability coefficient in Spanish samples at risk for hereditary cancer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychometric analysis of the questionnaires used to assess psychological distress and cancer worry</measure>
    <time_frame>Data collection for two years</time_frame>
    <description>Impact of Event Scale (IES), is a self-report measure for distress in relation to a stressful life event, which in our study is cancer risk. IES is using 15 items to measures psychological distress on two subscaless, with intrusion (the extent to which patients are overwhelmed by thoughts and feelings about cancer) and avoidance (tendency to avoid thoughts and feelings about cancer). The intrusion subscale has seven items, the avoidance subscale eight items. Each item is scored from 0 to 5. The psychometric properties of IES are good in samples with increased risk for hereditary breast cancer.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">800</enrollment>
  <condition>Cancer</condition>
  <condition>Psychological Distress</condition>
  <condition>Hereditary Diseases</condition>
  <condition>Genetic Counseling</condition>
  <arm_group>
    <arm_group_label>patients admitted to cancer genetic counseling test</arm_group_label>
    <description>Participants were recruited from all consecutive patients referred to the Cancer Genetic Program at the Hospital Universitari i Politècnic la Fe.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>assessment with psychometric questionnaire</intervention_name>
    <description>At the initial genetic consultation patients are informed about hereditary cancer risk and the genetic testing process. At the second genetic counseling appointment, after patients done tests, all participants were informed about the study purpose, and they signed the informed consent before the psychometric assessment. Those patients who agreed to participate, they were given the questionnaires to fill in. Also, background characteristics were reported including age, marital relationship, level of education, psychiatric antecedents.&#xD;
The time for completion the self-report measures was about 10 minutes. The psychometric assessment was occurred prior to delivering the results of genetic testing.</description>
    <arm_group_label>patients admitted to cancer genetic counseling test</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants were recruited from all consecutive patients referred to the Cancer Genetic&#xD;
        Program at the Hospital Universitari i Politècnic la Fe.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 18 and 80 years&#xD;
&#xD;
          -  Factors presumed predictive for hereditary cáncer&#xD;
&#xD;
          -  They agreed to participate in the research.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with cognitive impairment&#xD;
&#xD;
          -  Patients with difficulties to read and understand Spanish language.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital Universitari i Politècnic La Fe</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>May 30, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>February 8, 2021</last_update_submitted>
  <last_update_submitted_qc>February 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Universitario La Fe</investigator_affiliation>
    <investigator_full_name>Gemma Costa Requena</investigator_full_name>
    <investigator_title>PhD Clinical psychologist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Genetic Diseases, Inborn</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>August 11, 2022</submitted>
    <returned>July 11, 2023</returned>
    <submitted>July 13, 2023</submitted>
  </pending_results>
  <!-- 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/NCT04428710
org study id: Cancer Genetic Counseling.PSI
nct id: NCT04428710
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study of hereditary cancer related syndromes allows reducing the risk of suffering in
      cancer to patients and close relatives. The objective of this study will be to evaluate the
      prevelance of psychological morbidity in patients attended at cancer genetic counselling
      unit, and to determine the socio-demographic and clinical factors that influence it.

      A descriptive cross-sectional study will be carried out. Patients attented at the cancer
      genetic counselling unit, who have criteria for conducting a genetic syndrome test related to
      hererditary cancer, will be consecutively evaluated.

      To knowing the psychological morbidity it is relevant to providing care for these patients.
Nowadays several familial cancer syndromes that confer a high lifetime risk of cancer can be
      identified with genetic testing. The psychological impact of genetic testing and the rates of
      psychological distress in patients undergoing genetic testing vary between 6 to 65% depending
      on socio-demographic or clinical characteristics.

      The effect of baseline distress on post-testing assessments tended to decrease or show little
      change over time, it may be important to target patients with high baseline distress for
      additional counseling or intervention both pre-testing and over time.The most robust
      predictor of future distress is baseline distress, additional factors were associated with
      cancer risk perception considering family history of cancer, patient's affected or unaffected
      with cancer, etc...

      It is relevant to developing and providing care for these patients, it has been demonstrated
      that enhanced genetic counseling with clinical psychologist to facilitate decision-making
      process, managing family concerns promoting their communication with and involvement of
      family members, and attending their emotional distress, can be beneficial. Also, cancer
      genetic counseling may promote patient use of personal resources and enhance patient health
      literacy about their syndrome.
observational model: Cohort
time perspective: Cross-Sectional
measure: To determinate the prevalence of psychological distress of patients studied of the different hereditary cancer syndromes attended at Cancer Genetic Counseling Unit
time frame: Data collection for two years
description: The Hospital Anxiety and Depression Scale (HADS), it is consisting of two subscales with seven items respectively, anxiety (HADS-A) and depression (HADS-D) symptomatology. The questionnaire is used to evaluate psychological distress in non-psychiatric settings. In general medical outpatients the optimal cut-off point for the screening for psychiatric morbidity seems to be 12, for screening depressive symptomatology seems to be 5 score and 8 (range 7-10) for screening anxiety symptomatology. In Spanish population the HADS demonstrated a good internal consistency and optimal psychometric properties.
measure: To determinate cáncer worry of patients studied of the different hereditary cancer syndromes attended at Cancer Genetic Counseling Unit
time frame: Data collection for two years
description: Cancer Worry Scale. (CWS), consists of the six-item scale measures concerns about developing cancer, and the impact of these concerns on performing daily tasks among patients at risk for hereditary cancer. The questionnaire are rated on a 4-point Likert scale ranging from "never" to "almost always", with a total value ranging from 6 (minimal worry) to 24 (maximum worry). CWS presented good reliability coefficient in Spanish samples at risk for hereditary cancer.
measure: To determinate the prevalence of psychological morbidity of patients studied of the different hereditary cancer syndromes attended at Cancer Genetic Counseling Unit
time frame: Data collection for two years
description: The General Health Questionnaire (GHQ-28), measures psychological distress, which is consisting of social functioning, somatic symptoms, anxiety/sleep disturbances, and depression. Each item was scored from 0 to 3. Higher scores indicating greater psychological morbidity, with a cutting score of 5/6 to identify psychiatric morbidity. The Spanish version of the GHQ-28 had adequate psychometric properties.
measure: Find out differences on psychological distress regarding the hereditary syndrome studied at the cancer genetic counseling.
time frame: Data collection for two years
description: Psychometric questionnaire. Hospital Anxiety and Depresion Scale (HADS) , it is consisting of two subscales with seven items respectively, anxiety (HADS-A) and depression (HADS-D) symptomatology. The questionnaire is used to evaluate psychological distress in non-psychiatric settings. The optimal cut-off point for screening psychiatric morbidity seems to be 12, for screening depressive symptomatology seems to be 5 score and 8 (range 7-10) score for screening anxiety symptomatology. In Spanish population the HADS demonstrated a good internal consistency and optimal psychometric properties.
measure: Identify differences in cancer worry regarding the hereditary syndrome studied at the cancer genetic counseling.
time frame: Data collection for two years
description: Cancer Worry Scale (CWS). this questionnaire consists of the six-item measures concerns about developing cancer and the impact of these concerns on performing daily tasks among patients at risk for hereditary cancer. The questionnaire are rated on a 4-point Likert scale ranging from "never" to "almost always", with a total value ranging from 6 (minimal worry) to 24 (maximum worry). CWS presented good reliability coefficient in Spanish samples at risk for hereditary cancer.
measure: Psychometric analysis of the questionnaires used to assess psychological distress and cancer worry
time frame: Data collection for two years
description: Impact of Event Scale (IES), is a self-report measure for distress in relation to a stressful life event, which in our study is cancer risk. IES is using 15 items to measures psychological distress on two subscaless, with intrusion (the extent to which patients are overwhelmed by thoughts and feelings about cancer) and avoidance (tendency to avoid thoughts and feelings about cancer). The intrusion subscale has seven items, the avoidance subscale eight items. Each item is scored from 0 to 5. The psychometric properties of IES are good in samples with increased risk for hereditary breast cancer.
arm group label: patients admitted to cancer genetic counseling test
description: Participants were recruited from all consecutive patients referred to the Cancer Genetic Program at the Hospital Universitari i Politècnic la Fe.
intervention type: Other
intervention name: assessment with psychometric questionnaire
description: At the initial genetic consultation patients are informed about hereditary cancer risk and the genetic testing process. At the second genetic counseling appointment, after patients done tests, all participants were informed about the study purpose, and they signed the informed consent before the psychometric assessment. Those patients who agreed to participate, they were given the questionnaires to fill in. Also, background characteristics were reported including age, marital relationship, level of education, psychiatric antecedents.
The time for completion the self-report measures was about 10 minutes. The psychometric assessment was occurred prior to delivering the results of genetic testing.
arm group label: patients admitted to cancer genetic counseling test
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Hospital Universitario La Fe
investigator full name: Gemma Costa Requena
investigator title: PhD Clinical psychologist
mesh term: Genetic Diseases, Inborn
sharing ipd: Undecided
submitted: August 11, 2022
returned: July 11, 2023
submitted: July 13, 2023