xml: <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/NCT06028048</url>
    </required_header>
    <id_info>
      <org_study_id>24535</org_study_id>
      <nct_id>NCT06028048</nct_id>
    </id_info>
    <brief_title>Enhancing Work Participation of Unemployed and Work-Disabled Cancer Survivors</brief_title>
    <acronym>PLACES</acronym>
    <official_title>Protocol of a Randomized Controlled Trial on the Effectiveness and Cost-effectiveness of a Supported Employment Intervention Aimed at Enhancing Work Participation of Unemployed or Work-disabled Cancer Survivors: the PLACES Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</source>
    <oversight_info>
      <has_dmc>Yes</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 primary objective of this study is to evaluate the effectiveness of the PLACES&#xD;
        intervention on paid employment re-entry in unemployed and work-disabled cancer survivors,&#xD;
        compared to CAU.&#xD;
  &#xD;
        Secondary Objectives are:&#xD;
  &#xD;
          -  To evaluate the cost-effectiveness of the PLACES intervention aimed at unemployed or&#xD;
             work-disabled cancer survivors.&#xD;
  &#xD;
          -  To evaluate the effectiveness of the PLACES intervention on time until paid employment,&#xD;
             type of employment, change in working hours, quality of life, quality of working life,&#xD;
             work ability, and self-efficacy regarding RTW, in unemployed or work-disabled cancer&#xD;
             survivors.&#xD;
  &#xD;
          -  To evaluate the process of conducting the PLACES intervention in terms of recruitment,&#xD;
             reach, dose delivered, dose received, fidelity and context.&#xD;
  &#xD;
        Participants in the intervention group will receive the PLACES intervention with a maximum&#xD;
        duration of 1 year, and participants in the control group will receive CAU.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        About one third of all cancer survivors is not able to re-integrate into work and experiences&#xD;
        involuntary unemployment or partial or full work disability due to their cancer diagnosis and&#xD;
        treatment. For cancer survivors who lost their job, returning to paid employment can be&#xD;
        challenging due to uncertainty about their work ability, perceived employer discrimination&#xD;
        and a lack of support. They are at risk for social exclusion, yet return to work (RTW)&#xD;
        interventions are currently missing. Here, the protocol of the PLACES (unemPLoyed cAnCer&#xD;
        survivors Support) study is described. The aim of this study is to evaluate the effectiveness&#xD;
        and cost-effectiveness of a supported employment intervention on enhancing successful RTW of&#xD;
        unemployed and partly or fully work-disabled cancer survivors.&#xD;
  &#xD;
        A two-armed randomized controlled trial (RCT) will be carried out with a follow-up of&#xD;
        12-months. Eligible participants are: 1) aged between 18 and 65 years; 2) diagnosed with&#xD;
        cancer between 6 months and 10 years ago; 3) unemployed and partly or fully work-disabled; 4)&#xD;
        seeking paid employment; and 5) motivated to immediately start working in a new job.&#xD;
        Participants will be identified via the Netherlands Cancer Registry and recruited through&#xD;
        their medical specialist at the hospital or labour expert at the social security agency.&#xD;
        Participants in the intervention group (n=82) will receive a tailored supported employment&#xD;
        intervention, based on the principles of individual placement and support (IPS). This&#xD;
        includes support in seeking, returning to and maintaining paid employment. Participants in&#xD;
        the control group (n=82) will receive care as usual. All participants will be asked to&#xD;
        complete questionnaires, at baseline (T0), and after three (T1), six (T2) and 12 months (T3)&#xD;
        follow-up. The primary outcome is obtainment of paid employment. Secondary outcomes are&#xD;
        employment status, time until paid employment, change in working hours, importance of work,&#xD;
        RTW expectations, work ability, quality of (working) life, and self-efficacy regarding RTW.&#xD;
        Process evaluation and cost-effectiveness analysis will be performed.&#xD;
  &#xD;
        We expect that that a significantly higher proportion of participants in the intervention&#xD;
        group to obtain paid employment at any point during 12-month follow-up compared to&#xD;
        participants in the control group. Additionally, their health, financial situation and&#xD;
        quality of life will be improved. If proven effective, the intention is to implement the&#xD;
        intervention in usual rehabilitation care.&#xD;
  &#xD;
        The study is funded by the Dutch Cancer Society (KWF) and in collaboration with the&#xD;
        Netherlands comprehensive cancer organisation (IKNL) and the social security agency (SSA)&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2025</primary_completion_date>
    <phase>Phase 2/Phase 3</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>A non-blinded RCT will be conducted with a follow-up of 12 months. The study will compare two arms: (1) an intervention group, in which participants will receive the PLACES intervention, and (2) a control group, in which participants will receive CAU (Figure 1). Data on primary (i.e. obtainment of paid employment) and secondary outcomes (e.g. quality of life and self-efficacy regarding RTW) will be gathered at baseline (T0) and after three (T1), six (T2) and twelve months of follow up (T3) using questionnaires .</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>The analyses will be performed blinded after one researcher codes the intervention and control group to either 0 or 1.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Paid employment (yes/no)</measure>
      <time_frame>12 months</time_frame>
      <description>The primary outcome measure is paid employment (yes/no) at any point during the 1-year-follow-up. Being in paid employment is operationalised as working in a paid job for at least one hour per week as defined by the central statistics office.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Employment status</measure>
      <time_frame>Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3)</time_frame>
      <description>participants will be ask about their current work situation. A combination of answer options is possible: fulltime, parttime, self-employed, studying, retired, involuntary unemployed, voluntary unemployed, (partially) work-disabled, employed but on sick leave, unemployed and on sick leave, household/caring for others, and 'other'.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time until paid employment</measure>
      <time_frame>Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3)</time_frame>
      <description>2. Time until paid employment will be measured as the number of calendar days between randomization and the first day at paid employment. Participants will be asked about the date they started their new job. This can be used to calculate the number of days between randomization and starting in a new job.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in working hours</measure>
      <time_frame>Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3)</time_frame>
      <description>for each current work situation (e.g. part-time, voluntary, etc.) participants will be asked about the number of hours per week they work.The answers at different times of follow-up will be used to calculate the change in working hours.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Importance of work</measure>
      <time_frame>Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3)</time_frame>
      <description>4. Importance of work will be measured by rating the perceived importance of work in one's current situation on a visual analogue scale (VAS) ranging from 1 to 10, with higher scores indicating higher importance of work.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>RTW expectations</measure>
      <time_frame>Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3)</time_frame>
      <description>5. RTW expectation will be measured using a single question asking participants: 'in your estimation, what is the chance you will be at work in 6 months, measured on a 10-point rating scale from 1 (Very little chance) to 5 (very high chance).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Work ability</measure>
      <time_frame>Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3)</time_frame>
      <description>6. Work ability will be assessed using a single question of the Work Ability Index (WAI), asking participants to estimate their current work ability compared with their lifetime best (0, cannot work at all, to 10, best ever)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life</measure>
      <time_frame>Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3)</time_frame>
      <description>7. Quality of life will be assessed with the Short Form-12 (SF-12), which includes the subscales vitality, physical functioning, bodily pain, general health perceptions, physical role functioning.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of working life</measure>
      <time_frame>Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3)</time_frame>
      <description>8. Quality of working life will be measured with the 23-item cancer-specific quality of working life questionnaire (QWLQ-CS, 23 items)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self-efficacy regarding RTW</measure>
      <time_frame>Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3)</time_frame>
      <description>9. Self-efficacy regarding RTW is measured using the 11-item self-efficacy scale developed by Lagerveld et al. with higher scores indicating higher self-efficacy for RTW</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">164</enrollment>
    <condition>Cancer Survivors</condition>
    <condition>Return to Work</condition>
    <arm_group>
      <arm_group_label>PLACES intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants in the intervention group will receive the PLACES intervention during 12-months after randomization.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Care as usual</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Participants in the control group will receive usual care from the SSA.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>PLACES</intervention_name>
      <description>The PLACES intervention is based on eight IPS principles, ensuring competitive employment, client choice, service integration, personalized benefits counseling, rapid job search, systematic development, and individualized support.&#xD;
  Coaches: Certified IPS coaches receive training from Phrenos IPS knowledge center and Re-turn. Ongoing support includes video lectures, clarifications with researchers, and biannual collective sessions. Coaches, regionally specialized, implement interventions autonomously.&#xD;
  Intervention Phases:&#xD;
  Intake and Assessment: Participants meet IPS coaches within three days to discuss goals, procedures, and responsibilities, continuing until objectives are met.&#xD;
  Acquisition and Application: Coaches assist job search and placement, aiming for employment within 30 days.&#xD;
  Placement and Support: Coaches offer personalized support, adapting to needs, scheduling meetings based on preferences.&#xD;
  The intervention ends at 12 months or when goals are achieved.</description>
      <arm_group_label>PLACES intervention</arm_group_label>
      <other_name>Individual Placement and Support (IPS)</other_name>
      <other_name>Supported employment</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          In order to be eligible for participation, participants must meet all of the following&#xD;
          criteria:&#xD;
  &#xD;
            1. Of working age (18-65 years);&#xD;
  &#xD;
            2. Diagnosed with cancer between 6 months and 10 years ago;&#xD;
  &#xD;
            3. Unemployed and either partially or fully work-disabled&#xD;
  &#xD;
            4. They have completed their primary treatment (except long-term treatment such as&#xD;
               hormone therapy);&#xD;
  &#xD;
            5. An approved reintegration trajectory at the SSA;&#xD;
  &#xD;
            6. Seeking paid employment and motivated to initiate work promptly.&#xD;
  &#xD;
          Cancer survivors who are unable to speak, read or understand the Dutch language and cancer&#xD;
          survivors who got diagnosed with basal cell carcinoma will be excluded from participation.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Fenna van Ommen, Msc.</last_name>
      <phone>+31613812892</phone>
      <email>f.vanommen1@amsterdamumc.nl</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</investigator_affiliation>
      <investigator_full_name>Fenna van Ommen</investigator_full_name>
      <investigator_title>Prof. dr. Angela de Boer</investigator_title>
    </responsible_party>
    <keyword>Cancer survivors</keyword>
    <keyword>Return to Work</keyword>
    <keyword>Reintegration</keyword>
    <keyword>Unemployment</keyword>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>Questionnaire data will be gathered via Castor EDC (GCP-approved). Amsterdam UMC, location AMC has a processor agreement with Castor EDC: AMC Intranet - Castor EDC. All quantitative data will be stored in Access and SPSS databases. Data will be handled confidentially. Participants' personal data will be pseudonymized by means of codes that do not contain any identifiable information. A participant identification code list will be used to link the data to the participants. The key to the code list will be stored separately from the pseudonymized dataset. The code list will be stored in a locked storage area in the work office and safeguarded by the project leader. Only authorized members of the research team will have access to the key. The pseudonymized dataset will be stored on a secured Amsterdam UMC location AMC server, and safeguarded by authorized members of the research team, for 15 years.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06028048
  org study id: 24535
  nct id: NCT06028048
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The primary objective of this study is to evaluate the effectiveness of the PLACES
        intervention on paid employment re-entry in unemployed and work-disabled cancer survivors,
        compared to CAU.
  
        Secondary Objectives are:
  
          -  To evaluate the cost-effectiveness of the PLACES intervention aimed at unemployed or
             work-disabled cancer survivors.
  
          -  To evaluate the effectiveness of the PLACES intervention on time until paid employment,
             type of employment, change in working hours, quality of life, quality of working life,
             work ability, and self-efficacy regarding RTW, in unemployed or work-disabled cancer
             survivors.
  
          -  To evaluate the process of conducting the PLACES intervention in terms of recruitment,
             reach, dose delivered, dose received, fidelity and context.
  
        Participants in the intervention group will receive the PLACES intervention with a maximum
        duration of 1 year, and participants in the control group will receive CAU.
  About one third of all cancer survivors is not able to re-integrate into work and experiences
        involuntary unemployment or partial or full work disability due to their cancer diagnosis and
        treatment. For cancer survivors who lost their job, returning to paid employment can be
        challenging due to uncertainty about their work ability, perceived employer discrimination
        and a lack of support. They are at risk for social exclusion, yet return to work (RTW)
        interventions are currently missing. Here, the protocol of the PLACES (unemPLoyed cAnCer
        survivors Support) study is described. The aim of this study is to evaluate the effectiveness
        and cost-effectiveness of a supported employment intervention on enhancing successful RTW of
        unemployed and partly or fully work-disabled cancer survivors.
  
        A two-armed randomized controlled trial (RCT) will be carried out with a follow-up of
        12-months. Eligible participants are: 1) aged between 18 and 65 years; 2) diagnosed with
        cancer between 6 months and 10 years ago; 3) unemployed and partly or fully work-disabled; 4)
        seeking paid employment; and 5) motivated to immediately start working in a new job.
        Participants will be identified via the Netherlands Cancer Registry and recruited through
        their medical specialist at the hospital or labour expert at the social security agency.
        Participants in the intervention group (n=82) will receive a tailored supported employment
        intervention, based on the principles of individual placement and support (IPS). This
        includes support in seeking, returning to and maintaining paid employment. Participants in
        the control group (n=82) will receive care as usual. All participants will be asked to
        complete questionnaires, at baseline (T0), and after three (T1), six (T2) and 12 months (T3)
        follow-up. The primary outcome is obtainment of paid employment. Secondary outcomes are
        employment status, time until paid employment, change in working hours, importance of work,
        RTW expectations, work ability, quality of (working) life, and self-efficacy regarding RTW.
        Process evaluation and cost-effectiveness analysis will be performed.
  
        We expect that that a significantly higher proportion of participants in the intervention
        group to obtain paid employment at any point during 12-month follow-up compared to
        participants in the control group. Additionally, their health, financial situation and
        quality of life will be improved. If proven effective, the intention is to implement the
        intervention in usual rehabilitation care.
  
        The study is funded by the Dutch Cancer Society (KWF) and in collaboration with the
        Netherlands comprehensive cancer organisation (IKNL) and the social security agency (SSA)
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: A non-blinded RCT will be conducted with a follow-up of 12 months. The study will compare two arms: (1) an intervention group, in which participants will receive the PLACES intervention, and (2) a control group, in which participants will receive CAU (Figure 1). Data on primary (i.e. obtainment of paid employment) and secondary outcomes (e.g. quality of life and self-efficacy regarding RTW) will be gathered at baseline (T0) and after three (T1), six (T2) and twelve months of follow up (T3) using questionnaires .
  primary purpose: Other
  masking: Single (Outcomes Assessor)
  masking description: The analyses will be performed blinded after one researcher codes the intervention and control group to either 0 or 1.
  measure: Paid employment (yes/no)
  time frame: 12 months
  description: The primary outcome measure is paid employment (yes/no) at any point during the 1-year-follow-up. Being in paid employment is operationalised as working in a paid job for at least one hour per week as defined by the central statistics office.
  measure: Employment status
  time frame: Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3)
  description: participants will be ask about their current work situation. A combination of answer options is possible: fulltime, parttime, self-employed, studying, retired, involuntary unemployed, voluntary unemployed, (partially) work-disabled, employed but on sick leave, unemployed and on sick leave, household/caring for others, and 'other'.
  measure: Time until paid employment
  time frame: Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3)
  description: 2. Time until paid employment will be measured as the number of calendar days between randomization and the first day at paid employment. Participants will be asked about the date they started their new job. This can be used to calculate the number of days between randomization and starting in a new job.
  measure: Change in working hours
  time frame: Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3)
  description: for each current work situation (e.g. part-time, voluntary, etc.) participants will be asked about the number of hours per week they work.The answers at different times of follow-up will be used to calculate the change in working hours.
  measure: Importance of work
  time frame: Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3)
  description: 4. Importance of work will be measured by rating the perceived importance of work in one's current situation on a visual analogue scale (VAS) ranging from 1 to 10, with higher scores indicating higher importance of work.
  measure: RTW expectations
  time frame: Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3)
  description: 5. RTW expectation will be measured using a single question asking participants: 'in your estimation, what is the chance you will be at work in 6 months, measured on a 10-point rating scale from 1 (Very little chance) to 5 (very high chance).
  measure: Work ability
  time frame: Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3)
  description: 6. Work ability will be assessed using a single question of the Work Ability Index (WAI), asking participants to estimate their current work ability compared with their lifetime best (0, cannot work at all, to 10, best ever)
  measure: Quality of life
  time frame: Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3)
  description: 7. Quality of life will be assessed with the Short Form-12 (SF-12), which includes the subscales vitality, physical functioning, bodily pain, general health perceptions, physical role functioning.
  measure: Quality of working life
  time frame: Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3)
  description: 8. Quality of working life will be measured with the 23-item cancer-specific quality of working life questionnaire (QWLQ-CS, 23 items)
  measure: Self-efficacy regarding RTW
  time frame: Baseline (T0), after 3 months (T1), After 6 months (T2) and after 12 months (T3)
  description: 9. Self-efficacy regarding RTW is measured using the 11-item self-efficacy scale developed by Lagerveld et al. with higher scores indicating higher self-efficacy for RTW
  arm group label: PLACES intervention
  arm group type: Experimental
  description: Participants in the intervention group will receive the PLACES intervention during 12-months after randomization.
  arm group label: Care as usual
  arm group type: No Intervention
  description: Participants in the control group will receive usual care from the SSA.
  intervention type: Behavioral
  intervention name: PLACES
  description: The PLACES intervention is based on eight IPS principles, ensuring competitive employment, client choice, service integration, personalized benefits counseling, rapid job search, systematic development, and individualized support.
  Coaches: Certified IPS coaches receive training from Phrenos IPS knowledge center and Re-turn. Ongoing support includes video lectures, clarifications with researchers, and biannual collective sessions. Coaches, regionally specialized, implement interventions autonomously.
  Intervention Phases:
  Intake and Assessment: Participants meet IPS coaches within three days to discuss goals, procedures, and responsibilities, continuing until objectives are met.
  Acquisition and Application: Coaches assist job search and placement, aiming for employment within 30 days.
  Placement and Support: Coaches offer personalized support, adapting to needs, scheduling meetings based on preferences.
  The intervention ends at 12 months or when goals are achieved.
  arm group label: PLACES intervention
  other name: Individual Placement and Support (IPS)
  other name: Supported employment
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Fenna van Ommen, Msc.
  phone: +31613812892
  email: f.vanommen1@amsterdamumc.nl
  responsible party type: Principal Investigator
  investigator affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  investigator full name: Fenna van Ommen
  investigator title: Prof. dr. Angela de Boer
  sharing ipd: Undecided
  ipd description: Questionnaire data will be gathered via Castor EDC (GCP-approved). Amsterdam UMC, location AMC has a processor agreement with Castor EDC: AMC Intranet - Castor EDC. All quantitative data will be stored in Access and SPSS databases. Data will be handled confidentially. Participants' personal data will be pseudonymized by means of codes that do not contain any identifiable information. A participant identification code list will be used to link the data to the participants. The key to the code list will be stored separately from the pseudonymized dataset. The code list will be stored in a locked storage area in the work office and safeguarded by the project leader. Only authorized members of the research team will have access to the key. The pseudonymized dataset will be stored on a secured Amsterdam UMC location AMC server, and safeguarded by authorized members of the research team, for 15 years.