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<docDscr>
  <citation>
    <titlStmt>
      <titl>Psychological management of patients in the oncology context, presenting post-traumatic stress disorder in the context of the COVID-19 epidemic</titl>
      <IDNo>FRESH-PEF73967-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="CENTRE REGIONAL FRANCOIS BACLESSE" role="">Jean-Michel GRELLARD</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
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<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Psychological management of patients in the oncology context, presenting post-traumatic stress disorder in the context of the COVID-19 epidemic            </titl>
      <altTitl>
                    COVIPACT 2                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF73967-en            </IDNo>
      <IDNo agency="PEF">
                    73967                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF73967                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Jean-Michel GRELLARD                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="CENTRE REGIONAL FRANCOIS BACLESSE">
        <ExtLink title="ROR" URI="https://ror.org/00mrq0n58" role="organisation id"/>
        <ExtLink title="SIREN" URI="780709598" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            CENTRE REGIONAL FRANCOIS BACLESSE                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            CENTRE REGIONAL FRANCOIS BACLESSE                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="CENTRE REGIONAL FRANCOIS BACLESSE" email="jm.grellard@baclesse.unicancer.fr">
                    Jean-Michel;GRELLARD
                                            <ExtLink title="ROR" URI="https://ror.org/00mrq0n58" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="780709598" role="organisation id"/>
                                    </contact>
      <contact affiliation="CENTRE REGIONAL FRANCOIS BACLESSE" email="a.narayanassamy@baclesse.unicancer.fr">
                    Antony;NARAYANASSAMY
                                            <ExtLink title="ROR" URI="https://ror.org/00mrq0n58" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="780709598" role="organisation id"/>
                                    </contact>
      <depDate date="2026-06-17"/>
      <distDate date="2026-06-17"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <topcClas vocab="health theme">
                        Oncology                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/5784b7f1-c7ce-49d9-9f38-aebcda0ff41d"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D008495"/>
                                                </topcClas>
      <topcClas vocab="cim-11">
                        Neoplasms                                            </topcClas>
      <topcClas vocab="cim-11">
                        COVID-19                                            </topcClas>
    </subject>
    <abstract contentType="purpose">Evaluate the value of psychological management in patients with confirmed post-traumatic stress disorder (PTSD) related to the COVID-19 epidemic, in terms of the improvement in stress.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2021-01-01"/>
      <collDate event="end" date="2021-12-31"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <geogCover>Normandie</geogCover>
      <geogUnit/>
      <anlyUnit>
                Individuals            </anlyUnit>
      <universe level="type" clusion="I">Patients population                    </universe>
      <universe level="sex" clusion="I">Male                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008297"/>
                                                    </universe>
      <universe level="sex" clusion="I">Female                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D005260"/>
                                                    </universe>
      <universe level="age" clusion="I">Young Adult (19 to 24 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D055815"/>
                                                    </universe>
      <universe level="age" clusion="I">Adult (25 to 44 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000328"/>
                                                    </universe>
      <universe level="age" clusion="I">Middle Aged (45 to 64 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008875"/>
                                                    </universe>
      <universe level="age" clusion="I">Aged (65 to 79 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000368"/>
                                                    </universe>
      <universe level="age" clusion="I">Aged, 80 and over (80 years and more)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000369"/>
                                                    </universe>
      <universe clusion="I">Patient ≥ 18 years - Patient treated or followed up for a solid tumour at the François Baclesse Cancer Centre - Patient with a high post-traumatic stress disorder score (score ≥ 33 on the IES-R scale) related to the COVID-19 epidemic - Patient state of health compatible with implementation of the programme: psychological management for 6 months - Information leaflet signed by the patient - Any associated geographical, social or psychopathological condition liable to compromise the patient’s ability to take part in the study                    </universe>
      <dataKind>Clinical data</dataKind>
    </sumDscr>
  </stdyInfo>
  <method>
    <dataColl>
      <sampProc>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </sampProc>
      <targetSampleSize>
        <sampleSizeFormula>&lt; 500 individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Converting or copying information into a structured record                                                            <concept vocab="CESSDA" vocabURI="Transcription"/>
                                                    </collMode>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            To be defined                                                    </avlStatus>
    </setAvail>
  </dataAccs>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
