<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/NCT03245983</url>
  </required_header>
  <id_info>
    <org_study_id>2016-32</org_study_id>
    <nct_id>NCT03245983</nct_id>
  </id_info>
  <brief_title>Spirituality, Experience of Disease and Quality of Life in Cancer Patients</brief_title>
  <acronym>SPIQOL</acronym>
  <official_title>Spirituality, Experience of Disease and Quality of Life in Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique Hopitaux De Marseille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique Hopitaux De Marseille</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 general aim of research is to identify and analyze the impact and role of spirituality&#xD;
      (as a search for meaning and understanding of the meaning of existence) in the experience of&#xD;
      cancer. For this purpose, the main objective of this study is to measure the &quot;existential&quot;&#xD;
      component in the trajectory of the disease. It is a question of observing its potential&#xD;
      contribution to the improvement of the quality of life of the patients and to define if this&#xD;
      variable can be translated into a strategy of adjustment for the patients. This research has&#xD;
      a double interest: (a) clinical interest in better managing patients' needs; (B) an interest&#xD;
      in research in the field of health by combining a measure of spirituality with other&#xD;
      psycho-social variables.&#xD;
&#xD;
      The project is a prospective non-randomized mono-centric study by questionnaire and research&#xD;
      interview. It is a study that seeks to identify the role of spirituality in the experience of&#xD;
      illness (i.e. representations, adjustments, emotional distress) and as a determinant of the&#xD;
      quality of life of subjects with cancer pathology.&#xD;
&#xD;
      The interviews will be conducted by a psychologist to qualitatively collect the elements of&#xD;
      the lived experience of the disease in connection with the spiritual elements of the &quot;quest&#xD;
      for meaning&quot; type.&#xD;
&#xD;
      The population covered by the project is in and out patients coming to the Department of&#xD;
      Medical Oncology and Palliative Care at the CHU de la Timone.&#xD;
&#xD;
      The realization of this project will allow investigators to explore the specificity of the&#xD;
      existential / spiritual dimensions of patients confronted with cancer, to assess the&#xD;
      patients' needs for this type of approach within the hospital, to link the existential&#xD;
      component / Spiritual with psycho-social variables&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 6, 2017</start_date>
  <completion_date type="Actual">February 19, 2020</completion_date>
  <primary_completion_date type="Actual">February 19, 2020</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Descriptive analysis of quality of life in patient cancer</measure>
    <time_frame>36 months</time_frame>
    <description>Questionnaires(QLQC30) for patients with cancer.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Descriptive analysis of spirituality role in cancer patient</measure>
    <time_frame>36 month</time_frame>
    <description>Spirituality Index of Well-Being questionnaire</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">162</enrollment>
  <condition>Psychology and Cancer</condition>
  <arm_group>
    <arm_group_label>Patient willing to participate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Questionnaire and interview</intervention_name>
    <description>Cancer patients will answer questionnaires and will be interviewed by a pshychologist to assess their spirituality and quality of life toward their disease</description>
    <arm_group_label>Patient willing to participate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient undergoing chemotherapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient presenting psychiatric or neurological disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Urielle DESALBRES</last_name>
    <role>Study Director</role>
    <affiliation>Assistance Publique -Hôpitaux de Marseille</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Assistance Publique Hôpitaux de Marseille</name>
      <address>
        <city>Marseille</city>
        <zip>13354</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>August 8, 2022</last_update_submitted>
  <last_update_submitted_qc>August 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03245983
org study id: 2016-32
nct id: NCT03245983
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The general aim of research is to identify and analyze the impact and role of spirituality
      (as a search for meaning and understanding of the meaning of existence) in the experience of
      cancer. For this purpose, the main objective of this study is to measure the "existential"
      component in the trajectory of the disease. It is a question of observing its potential
      contribution to the improvement of the quality of life of the patients and to define if this
      variable can be translated into a strategy of adjustment for the patients. This research has
      a double interest: (a) clinical interest in better managing patients' needs; (B) an interest
      in research in the field of health by combining a measure of spirituality with other
      psycho-social variables.

      The project is a prospective non-randomized mono-centric study by questionnaire and research
      interview. It is a study that seeks to identify the role of spirituality in the experience of
      illness (i.e. representations, adjustments, emotional distress) and as a determinant of the
      quality of life of subjects with cancer pathology.

      The interviews will be conducted by a psychologist to qualitatively collect the elements of
      the lived experience of the disease in connection with the spiritual elements of the "quest
      for meaning" type.

      The population covered by the project is in and out patients coming to the Department of
      Medical Oncology and Palliative Care at the CHU de la Timone.

      The realization of this project will allow investigators to explore the specificity of the
      existential / spiritual dimensions of patients confronted with cancer, to assess the
      patients' needs for this type of approach within the hospital, to link the existential
      component / Spiritual with psycho-social variables
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Descriptive analysis of quality of life in patient cancer
time frame: 36 months
description: Questionnaires(QLQC30) for patients with cancer.
measure: Descriptive analysis of spirituality role in cancer patient
time frame: 36 month
description: Spirituality Index of Well-Being questionnaire
arm group label: Patient willing to participate
arm group type: Experimental
intervention type: Behavioral
intervention name: Questionnaire and interview
description: Cancer patients will answer questionnaires and will be interviewed by a pshychologist to assess their spirituality and quality of life toward their disease
arm group label: Patient willing to participate
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Urielle DESALBRES
role: Study Director
affiliation: Assistance Publique -Hôpitaux de Marseille
facility: 
country: France
responsible party type: Sponsor
sharing ipd: Undecided