<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/NCT02205853</url>
  </required_header>
  <id_info>
    <org_study_id>NKI 2010-4854</org_study_id>
    <nct_id>NCT02205853</nct_id>
  </id_info>
  <brief_title>Implementation of Physical Cancer Rehabilitation Programmes in a European Healthcare System.</brief_title>
  <official_title>An Evaluation of a Patient-directed Strategy Compared With a Multi-faceted Strategy to Implement Physical Cancer Rehabilitation Programmes; a Controlled Before and After Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Radboud University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Radboud University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to develop and identify the most effective strategy to implement&#xD;
      PCRPs into daily care. We want to assess the added value of a multi-faceted strategy compared&#xD;
      with a single-faceted patient-directed strategy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to develop and identify the most effective strategy to implement&#xD;
      PCRPs into daily care. We want to assess the added value of a multi-faceted strategy compared&#xD;
      with a single-faceted patient-directed strategy.&#xD;
&#xD;
      We will conduct a clustered controlled before and after study (CBA) in the Netherlands that&#xD;
      compares two strategies to implement PCRPs. The patient-directed (PD) strategy (five&#xD;
      hospitals) will focus on change at the patient level. The multi-faceted (MF) strategy (five&#xD;
      hospitals) will focus on change at the patient, professional and organizational levels.&#xD;
      Eligibility criteria are as follows: (A) patients: adults; preferably (history of) cancer in&#xD;
      the gastro-intestinal, reproductive and/or urological system; successful primary treatment;&#xD;
      and without recurrence/metastases. (B) Healthcare professionals: involved in cancer care.&#xD;
&#xD;
      A stepwise approach will be followed:&#xD;
&#xD;
      Step 1: Analysis of the current implementation of PCRPs and the examination of barriers and&#xD;
      facilitators for implementation, via a qualitative study with patients (four focus groups n =&#xD;
      10-12) and their healthcare workers (four focus groups n = 10-12 and individual interviews n&#xD;
      = 30-40) and collecting data on adherence to quality indicators (n = 500 patients, 50 per&#xD;
      hospital).&#xD;
&#xD;
      Step 2: Selection and development of interventions to create a PD and MF strategy during&#xD;
      expert's roundtable discussions, using the knowledge gained in step 1 and a literature search&#xD;
      of the effect of strategies for implementing PCRPs.&#xD;
&#xD;
      Step 3: Test and compare both strategies with a clustered CBA (effectiveness, process&#xD;
      evaluation and costs), by data extraction from existing registration systems, questionnaires&#xD;
      and interviews. For the effectiveness and cost-effectiveness, n = 500 patients, 50 per&#xD;
      hospital. For the process evaluation, n=50 patients, 5 per hospital, and n = 40 healthcare&#xD;
      professionals, 4 per hospital.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <primary_completion_date type="Anticipated">October 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
  </study_design_info>
  <primary_outcome>
    <measure>The percentage of screened patients with the screening tool recommended by the Dutch guideline 'Cancer Rehabilitation'.</measure>
    <time_frame>baseline and at follow-up</time_frame>
    <description>A pre- and post measurement of 'the percentage of screened patients with the screening tool recommended by the Dutch guideline 'Cancer Rehabilitation'' will be done. The differences between the pre- and post measurement will be measured.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The percentage of referrals to PCRPs where needed, according to the Dutch guideline 'Cancer Rehabilitation'.</measure>
    <time_frame>baseline and at follow-up</time_frame>
    <description>A pre- and post measurement of 'The percentage of referrals to PCRPs where needed, according to the Dutch guideline 'Cancer Rehabilitation'' will be done. The differences between the pre- and post measurement will be measured.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>baseline and at follow-up</time_frame>
    <description>A pre- and post measurement of 'QoL' will be done. The differences between the pre- and post measurement will be measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patientempowerment</measure>
    <time_frame>baseline and at follow-up</time_frame>
    <description>A pre- and post measurement of 'patientempowerment' will be done. The differences between the pre- and post measurement will be measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Remaining quality indicators of the Dutch guideline 'Cancer Rehabilitation'.</measure>
    <time_frame>baseline and at follow-up</time_frame>
    <description>A pre- and post measurement of ' the Remaining quality indicators of the Dutch guideline 'Cancer Rehabilitation'' will be done. The differences between the pre- and post measurement will be measured.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Process-evaluation</measure>
    <time_frame>at follow-up</time_frame>
    <description>The experiences and exposure of patients and professionals with the PD- and MF strategy will be evaluated by interviews.</description>
  </other_outcome>
  <other_outcome>
    <measure>Cost</measure>
    <time_frame>at follow-up</time_frame>
    <description>incremental costs and incremental cost-effectiveness ratios (ICERs)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Cancer</condition>
  <condition>Fatigue</condition>
  <arm_group>
    <arm_group_label>The patient-directed (PD) strategy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>A single-faceted patient-directed (PD) strategy that will embed the change at patient level.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>The multi-faceted (MF) strategy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>A multi-faceted (MF) strategy that will embed the change at the patient, professional and organizational levels.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>The patient-directed (PD) strategy</intervention_name>
    <description>The patient-directed strategy will be designed to embed the success of implementation of PCRPs by influencing the patients.</description>
    <arm_group_label>The patient-directed (PD) strategy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>The multi-faceted (MF) strategy</intervention_name>
    <description>The multi-faceted strategy will be designed to embed the success by not only influencing the patients, but also professionals and organizational aspects.</description>
    <arm_group_label>The multi-faceted (MF) strategy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        patients:&#xD;
&#xD;
          -  preferably (history of) cancer in the gastro-intestinal, reproductive and/or&#xD;
             urological system; successful primary treatment; and without recurrence/metastases.&#xD;
&#xD;
          -  Adults&#xD;
&#xD;
          -  Diagnosed in one of the participating hospitals&#xD;
&#xD;
          -  Able to read and understand Dutch&#xD;
&#xD;
        Healthcare professionals:&#xD;
&#xD;
        • involved in cancer care in one of the participating hospitals&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>C. IJsbrandy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Radboud Univeristy Medical Centre Nijmegen</affiliation>
  </overall_official>
  <overall_official>
    <last_name>R.P.M.G. Hermens, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Radboud Univeristy Medical Centre Nijmegen</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>C. IJsbrandy, MD</last_name>
    <phone>+31 (0)24 3615305</phone>
    <email>charlotte.ijsbrandy@radboudumc.nl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>R.P.M.G. Hermens, PhD</last_name>
    <phone>+31 (0)24 3615305</phone>
    <email>Rosella.hermens@radboudumc.nl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Radboud University Nijmegen Medical Center</name>
      <address>
        <city>Nijmegen</city>
        <state>Gelderland</state>
        <zip>6500HB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>C. IJsbrandy, drs.</last_name>
      <email>charlotte.ijsbrandy@radboudumc.nl</email>
    </contact>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>July 21, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 31, 2014</study_first_posted>
  <last_update_submitted>September 4, 2015</last_update_submitted>
  <last_update_submitted_qc>September 4, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 7, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Radboud University Medical Center</investigator_affiliation>
    <investigator_full_name>Rosella Hermens</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <keyword>Oncology Service Hospital</keyword>
  <keyword>Patient-centred</keyword>
  <keyword>Exercise</keyword>
  <keyword>Neoplasms</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>Qualitative Research</keyword>
  <keyword>Health Plan Implementation</keyword>
  <keyword>Quality of Health Care</keyword>
  <keyword>Guidelines</keyword>
  <keyword>Quality of Life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatigue</mesh_term>
  </condition_browse>
  <!-- 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/NCT02205853
org study id: NKI 2010-4854
nct id: NCT02205853
lead sponsor: 
has dmc: No
The aim of this study is to develop and identify the most effective strategy to implement
      PCRPs into daily care. We want to assess the added value of a multi-faceted strategy compared
      with a single-faceted patient-directed strategy.
The aim of this study is to develop and identify the most effective strategy to implement
      PCRPs into daily care. We want to assess the added value of a multi-faceted strategy compared
      with a single-faceted patient-directed strategy.

      We will conduct a clustered controlled before and after study (CBA) in the Netherlands that
      compares two strategies to implement PCRPs. The patient-directed (PD) strategy (five
      hospitals) will focus on change at the patient level. The multi-faceted (MF) strategy (five
      hospitals) will focus on change at the patient, professional and organizational levels.
      Eligibility criteria are as follows: (A) patients: adults; preferably (history of) cancer in
      the gastro-intestinal, reproductive and/or urological system; successful primary treatment;
      and without recurrence/metastases. (B) Healthcare professionals: involved in cancer care.

      A stepwise approach will be followed:

      Step 1: Analysis of the current implementation of PCRPs and the examination of barriers and
      facilitators for implementation, via a qualitative study with patients (four focus groups n =
      10-12) and their healthcare workers (four focus groups n = 10-12 and individual interviews n
      = 30-40) and collecting data on adherence to quality indicators (n = 500 patients, 50 per
      hospital).

      Step 2: Selection and development of interventions to create a PD and MF strategy during
      expert's roundtable discussions, using the knowledge gained in step 1 and a literature search
      of the effect of strategies for implementing PCRPs.

      Step 3: Test and compare both strategies with a clustered CBA (effectiveness, process
      evaluation and costs), by data extraction from existing registration systems, questionnaires
      and interviews. For the effectiveness and cost-effectiveness, n = 500 patients, 50 per
      hospital. For the process evaluation, n=50 patients, 5 per hospital, and n = 40 healthcare
      professionals, 4 per hospital.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
measure: The percentage of screened patients with the screening tool recommended by the Dutch guideline 'Cancer Rehabilitation'.
time frame: baseline and at follow-up
description: A pre- and post measurement of 'the percentage of screened patients with the screening tool recommended by the Dutch guideline 'Cancer Rehabilitation'' will be done. The differences between the pre- and post measurement will be measured.
measure: The percentage of referrals to PCRPs where needed, according to the Dutch guideline 'Cancer Rehabilitation'.
time frame: baseline and at follow-up
description: A pre- and post measurement of 'The percentage of referrals to PCRPs where needed, according to the Dutch guideline 'Cancer Rehabilitation'' will be done. The differences between the pre- and post measurement will be measured.
measure: Quality of life
time frame: baseline and at follow-up
description: A pre- and post measurement of 'QoL' will be done. The differences between the pre- and post measurement will be measured.
measure: Patientempowerment
time frame: baseline and at follow-up
description: A pre- and post measurement of 'patientempowerment' will be done. The differences between the pre- and post measurement will be measured.
measure: Remaining quality indicators of the Dutch guideline 'Cancer Rehabilitation'.
time frame: baseline and at follow-up
description: A pre- and post measurement of ' the Remaining quality indicators of the Dutch guideline 'Cancer Rehabilitation'' will be done. The differences between the pre- and post measurement will be measured.
measure: Process-evaluation
time frame: at follow-up
description: The experiences and exposure of patients and professionals with the PD- and MF strategy will be evaluated by interviews.
measure: Cost
time frame: at follow-up
description: incremental costs and incremental cost-effectiveness ratios (ICERs)
arm group label: The patient-directed (PD) strategy
arm group type: Other
description: A single-faceted patient-directed (PD) strategy that will embed the change at patient level.
arm group label: The multi-faceted (MF) strategy
arm group type: Other
description: A multi-faceted (MF) strategy that will embed the change at the patient, professional and organizational levels.
intervention type: Other
intervention name: The patient-directed (PD) strategy
description: The patient-directed strategy will be designed to embed the success of implementation of PCRPs by influencing the patients.
arm group label: The patient-directed (PD) strategy
intervention type: Other
intervention name: The multi-faceted (MF) strategy
description: The multi-faceted strategy will be designed to embed the success by not only influencing the patients, but also professionals and organizational aspects.
arm group label: The multi-faceted (MF) strategy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: C. IJsbrandy, MD
role: Principal Investigator
affiliation: Radboud Univeristy Medical Centre Nijmegen
last name: R.P.M.G. Hermens, PhD
role: Study Chair
affiliation: Radboud Univeristy Medical Centre Nijmegen
last name: C. IJsbrandy, MD
phone: +31 (0)24 3615305
email: charlotte.ijsbrandy@radboudumc.nl
last name: R.P.M.G. Hermens, PhD
phone: +31 (0)24 3615305
email: Rosella.hermens@radboudumc.nl
facility: 
status: Recruiting
contact: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Radboud University Medical Center
investigator full name: Rosella Hermens
investigator title: Dr
mesh term: Fatigue