<?xml version="1.0" encoding="UTF-8"?>
<codeBook version="2.5" ID="FRESH-PEF8125-en" xml-lang="en" xmlns="ddi:codebook:2_5" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="ddi:codebook:2_5 https://ddialliance.org/Specification/DDI-Codebook/2.5/XMLSchema/codebook.xsd">
<docDscr>
  <citation>
    <titlStmt>
      <titl>Multiple Morbidities for Elderly People with Breast Cancer</titl>
      <IDNo>FRESH-PEF8125-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES" role="">Laure DE DECKER</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Multiple Morbidities for Elderly People with Breast Cancer            </titl>
      <altTitl>
                    PAMS                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF8125-en            </IDNo>
      <IDNo agency="PEF">
                    8125                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF8125                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Laure DE DECKER                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES">
        <ExtLink title="ROR" URI="https://ror.org/05c1qsg97" role="organisation id"/>
        <ExtLink title="SIREN" URI="264400136" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES" email="laure.dedecker@chu-nantes.fr">
                    Laure;DE DECKER
                                            <ExtLink title="ROR" URI="https://ror.org/05c1qsg97" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="264400136" 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>
      <keyword vocab="" vocabURI="">
                    Comorbidity</keyword>
      <keyword vocab="" vocabURI="">
                    oncological therapeutic toxicities</keyword>
      <keyword vocab="" vocabURI="">
                    geriatrics</keyword>
      <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="health theme">
                        Geriatrics                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/d37e4d8c-a978-40c7-ba4f-eee841851073"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D005853"/>
                                                </topcClas>
      <topcClas vocab="health theme">
                        Gynaecology and obstetrics                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/7de64596-5b0d-4977-8f98-b982ff2ec17d"/>
                                                            <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/284ca20c-beb4-4abe-99fa-ef4513358bad"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D006176"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D009774"/>
                                                </topcClas>
      <topcClas vocab="cim-11">
                        Malignant neoplasms of breast                                            </topcClas>
      <topcClas vocab="health determinant">
                        Biological determinants: Genetic predisposition                    </topcClas>
      <topcClas vocab="health determinant">
                        Behavioral determinants                    </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants: Use of care                    </topcClas>
      <topcClas vocab="health determinant">
                        Biological determinants                    </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants                    </topcClas>
    </subject>
    <abstract contentType="purpose">The main objective of the PAM study is to develop a prognostic score at 5-year survival for patients older than 65 years who have breast cancer. This score is calculated from breast cancer variables, medical, psychological and social characteristics, burden of morbidity, frailty and quality of life. Secondary objectives of the PAMS study are: - To investigate the influence of individually analysed geriatric parameters on choice of oncology treatment at 3 months. - To investigate the influence of quality of life on survival and the onset of toxicity at 3 months, 1 year and 5 years. To investigate the change in quality of life for patients at 3 months (immediately post-treatment), at 1 year (during chronic treatment and follow-up) and at 5 years. - To study changes in perception (Response Shift) over time through quality of life questionnaires, so as to distinguish between what is a change in perception and what is a change in quality of life when analysing changes in quality of life scores - To study the links between changes in perception over time through quality of life questionnaires and scores from Impact of Cancer questionnaires (IOC). - To evaluate the change in physical performance and autonomy in patients at 3 months, 12 months and 5 years. - To investigate the validity of the Lee Survival Score in this population at 5 years. - To investigate the geriatric and oncological parameters associated with sought medical healthcare, defined by unscheduled hospitalisation in the year following enrolment, at 3 months, 1 year and 5 years. - To assess the association between self-administered health questionnaires and geriatric evaluation parameters for this population. - To determine associations between prognostic score, onset of toxicity and oncology therapy at 5 years. - To determine associations between geriatric parameters, onset of toxicity and oncology therapy at 5 years. - To determine the most efficient comorbidity scale for estimating the tolerance to treatment offered to elderly people with breast cancer by stratifying tumour type and initial grade, as well as choice of treatment at 1 year.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date=""/>
      <collDate event="end" date=""/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <geogCover>Pays de la Loire</geogCover>
      <geogUnit/>
      <anlyUnit>
                Individuals            </anlyUnit>
      <universe level="type" clusion="I">Patients population                    </universe>
      <universe level="sex" clusion="I">Female                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D005260"/>
                                                    </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">Individuals over 65 years of age - Individuals diagnosed with breast cancer by anatomopathological confirmation - Individuals that have given written informed consent to participate in the study or informed consent by the person legally responsible. - Subjects covered by a social security scheme. - Subjects monitored by a cancer treatment centre or oncology service participating in the study.                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Participant-reported health data</dataKind>
      <dataKind>Biological data</dataKind>
    </sumDscr>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health event/morbidity
Health event/mortality
Health care consumption and services
Quality of life/health perception</description>
    </developmentActivity>
  </studyDevelopment>
  <method>
    <dataColl>
      <sampProc>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </sampProc>
      <sampleFrame>
        <frameUnit>
          <unitType>Through organizations (health services or institutions</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>schools</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>businesses</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>etc.)</unitType>
        </frameUnit>
      </sampleFrame>
      <targetSampleSize>
        <sampleSizeFormula>[500-1000[ 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>
    <notes subject="observational study method">
                        Cohort study                    </notes>
    <anlyInfo>
      <respRate>800</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Restricted access                                                    </avlStatus>
    </setAvail>
    <useStmt>
      <conditions>Contact the principal investigator</conditions>
    </useStmt>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
