<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/NCT03230305</url>
  </required_header>
  <id_info>
    <org_study_id>NI15022</org_study_id>
    <nct_id>NCT03230305</nct_id>
  </id_info>
  <brief_title>Elderly CAncer Patient: Qualitative and Quantitative Factors of Inclusion Failure in Clinical Trials</brief_title>
  <acronym>Quali-SAGE</acronym>
  <official_title>Elderly CAncer Patient: Qualitative and Quantitative Factors of Inclusion Failure in Clinical Trials</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</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 transposition of the results of biomedical research to medical management of patients in&#xD;
      real-life setting depends highly from patient's selection. In Europe and the United States,&#xD;
      the majority of cancers occur after 65 years. In France, 45% of cancers diagnosed in 2012&#xD;
      were after 70 years or 158,722 in absolute value. In this context, the median age at&#xD;
      diagnosis was 72 years old. Disease particularly affecting the elderly, cancer is also&#xD;
      characterized by the importance of biomedical research devoted to it. Despite the dynamism of&#xD;
      the research activity in oncology and therefore the number of affected patients, the elderly&#xD;
      are paradoxically sparsely included in clinical trials. Numerous studies have focused in&#xD;
      recent years, to identify possible causes of under-representation of elderly patients in&#xD;
      clinical trials but most of them focused on eligibility criteria and few on barriers related&#xD;
      to non-invitation or non-inclusion in eligible patients.&#xD;
&#xD;
      The investigator postulate that a qualitative survey based on an structured epidemiological&#xD;
      device will able to objective evidences of reasons related to the patient, participant&#xD;
      familial caregivers, participant physician and the clinical center organization for&#xD;
      participating or not to a clinical trial and the interrelations between the identified&#xD;
      reasons.&#xD;
&#xD;
      The main objective is to assess reasons of non-participation of older patients with cancer in&#xD;
      clinical trials, from the physicians, patients and family caregivers' perspectives using&#xD;
      qualitative and quantitative methods.&#xD;
&#xD;
      The secondary objectives are:&#xD;
&#xD;
      To investigate the social representation and construction of being &quot;aged&quot; from the patient,&#xD;
      physician and family caregiver perspective (qualitative part).&#xD;
&#xD;
      To compare the reasons of non-participation regarding age class (old and very old), localized&#xD;
      versus metastatic disease and tumor site (quantitative part).&#xD;
&#xD;
      To characterize the profiles of participants and non-participants to clinical trial among&#xD;
      older patients with cancer thanks to qualitative and quantitative data.&#xD;
&#xD;
      Method Quali SAGE is a French, socio-epidemiologic, multicenter prospective study that&#xD;
      includes patients aged 70 years or over, with solid tumor (irrespective of the stage) in&#xD;
      French hospitals.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 12, 2017</start_date>
  <completion_date type="Actual">August 17, 2020</completion_date>
  <primary_completion_date type="Actual">August 17, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Invitation to participate in at least one clinical trial currently ongoing</measure>
    <time_frame>one year follow up</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Inclusion in at least one clinical trial currently ongoing</measure>
    <time_frame>one year follow up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary exclusion or Premature Termination or Withdrawal</measure>
    <time_frame>one year follow up</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">313</enrollment>
  <condition>Elderly</condition>
  <condition>Cancer</condition>
  <condition>Ethnographic Interview</condition>
  <condition>Social Representation of Being Aged</condition>
  <condition>Reasons of Non-participation in Clinical Trials</condition>
  <condition>Qualitative Method</condition>
  <arm_group>
    <arm_group_label>Elderly cancer patient cohort</arm_group_label>
    <description>Aged 70 years or over&#xD;
With solid cancer irrespective of the stage&#xD;
Pre-screened or screened for at least one ongoing clinical trial in the center&#xD;
Informed oral consent (patient, his/her legal representant, trustworthy person or family member)&#xD;
Social security affiliation</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ethnographic interview</intervention_name>
    <description>If a patient is invited to participate in the a clinical trial, inclusion's status (included or/not) will be sought.&#xD;
If included: an ethnographic interview will be held with patient (or his representant) who agreed to participate in the clinical trial, his family caregivers, his physician(s) in charge of him and the trial and, and clinical studies technician responsible for management.&#xD;
If not included, an ethnographic interview has offered to him, his caregivers, his physician(s) in charge of him and the trial and clinical studies technician responsible for management. In parallel, the reasons for non-inclusion are collected from a pre-established epidemiological questionnaire.&#xD;
If a patient is not invited to participate,an ethnographic interview will be held with his physician(s) in charge of him and the clinical trial and with clinical studies technician responsible for management.The reasons for non-invitation will be collected from an epidemiological survey multiple choices.</description>
    <arm_group_label>Elderly cancer patient cohort</arm_group_label>
    <other_name>Socio-demographic interview</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Population: all patients aged 70 years or more with a solid cancer and&#xD;
        pre-screened/screened for at least one clinical trial ongoing in the center&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 70 years or over&#xD;
&#xD;
          -  With solid cancer irrespective of the stage&#xD;
&#xD;
          -  Pre-screened or screened for at least one ongoing clinical trial in the center&#xD;
&#xD;
          -  Informed oral consent (patient, his/her legal representant, trustworthy person or&#xD;
             family member)&#xD;
&#xD;
          -  Social security affiliation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Florence Canouï-Poitrine, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Henri Mondor Hospital</name>
      <address>
        <city>Creteil</city>
        <zip>94010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>November 19, 2020</last_update_submitted>
  <last_update_submitted_qc>November 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Elderly</keyword>
  <keyword>Cancer</keyword>
  <keyword>Ethnographic interview</keyword>
  <keyword>Social representation</keyword>
  <keyword>Clinical trials</keyword>
  <keyword>Reasons of non-participation</keyword>
  <keyword>Qualitative method</keyword>
  <!-- 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/NCT03230305
org study id: NI15022
nct id: NCT03230305
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The transposition of the results of biomedical research to medical management of patients in
      real-life setting depends highly from patient's selection. In Europe and the United States,
      the majority of cancers occur after 65 years. In France, 45% of cancers diagnosed in 2012
      were after 70 years or 158,722 in absolute value. In this context, the median age at
      diagnosis was 72 years old. Disease particularly affecting the elderly, cancer is also
      characterized by the importance of biomedical research devoted to it. Despite the dynamism of
      the research activity in oncology and therefore the number of affected patients, the elderly
      are paradoxically sparsely included in clinical trials. Numerous studies have focused in
      recent years, to identify possible causes of under-representation of elderly patients in
      clinical trials but most of them focused on eligibility criteria and few on barriers related
      to non-invitation or non-inclusion in eligible patients.

      The investigator postulate that a qualitative survey based on an structured epidemiological
      device will able to objective evidences of reasons related to the patient, participant
      familial caregivers, participant physician and the clinical center organization for
      participating or not to a clinical trial and the interrelations between the identified
      reasons.

      The main objective is to assess reasons of non-participation of older patients with cancer in
      clinical trials, from the physicians, patients and family caregivers' perspectives using
      qualitative and quantitative methods.

      The secondary objectives are:

      To investigate the social representation and construction of being "aged" from the patient,
      physician and family caregiver perspective (qualitative part).

      To compare the reasons of non-participation regarding age class (old and very old), localized
      versus metastatic disease and tumor site (quantitative part).

      To characterize the profiles of participants and non-participants to clinical trial among
      older patients with cancer thanks to qualitative and quantitative data.

      Method Quali SAGE is a French, socio-epidemiologic, multicenter prospective study that
      includes patients aged 70 years or over, with solid tumor (irrespective of the stage) in
      French hospitals.
observational model: Cohort
time perspective: Prospective
measure: Invitation to participate in at least one clinical trial currently ongoing
time frame: one year follow up
measure: Inclusion in at least one clinical trial currently ongoing
time frame: one year follow up
measure: Secondary exclusion or Premature Termination or Withdrawal
time frame: one year follow up
arm group label: Elderly cancer patient cohort
description: Aged 70 years or over
With solid cancer irrespective of the stage
Pre-screened or screened for at least one ongoing clinical trial in the center
Informed oral consent (patient, his/her legal representant, trustworthy person or family member)
Social security affiliation
intervention type: Other
intervention name: Ethnographic interview
description: If a patient is invited to participate in the a clinical trial, inclusion's status (included or/not) will be sought.
If included: an ethnographic interview will be held with patient (or his representant) who agreed to participate in the clinical trial, his family caregivers, his physician(s) in charge of him and the trial and, and clinical studies technician responsible for management.
If not included, an ethnographic interview has offered to him, his caregivers, his physician(s) in charge of him and the trial and clinical studies technician responsible for management. In parallel, the reasons for non-inclusion are collected from a pre-established epidemiological questionnaire.
If a patient is not invited to participate,an ethnographic interview will be held with his physician(s) in charge of him and the clinical trial and with clinical studies technician responsible for management.The reasons for non-invitation will be collected from an epidemiological survey multiple choices.
arm group label: Elderly cancer patient cohort
other name: Socio-demographic interview
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 70 Years
maximum age: N/A
healthy volunteers: No
last name: Florence Canouï-Poitrine, MD, PhD
role: Principal Investigator
affiliation: Assistance Publique - Hôpitaux de Paris
facility: 
country: France
responsible party type: Sponsor