<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/NCT03838861</url>
  </required_header>
  <id_info>
    <org_study_id>Stinne1977</org_study_id>
    <nct_id>NCT03838861</nct_id>
  </id_info>
  <brief_title>An Individualised and Patient-centred Follow-up Program for Women With Gynaecological Cancer</brief_title>
  <acronym>NEMO</acronym>
  <official_title>A Randomised Clinical Trial Testing the Effect of an Individualised and Patient-centred Follow-up Program for Women With Gynaecological Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Region of Southern Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Danish Cancer Society</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Southern Denmark</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>
      This randomized controlled trial is testing the hypothesis that an individually focused and&#xD;
      need-based nurse led follow-up program supported by electronic Patient Reported Outcome&#xD;
      Measures for women with gynecological cancer will improve patient's empowerment, quality of&#xD;
      life and involvement in the follow-up process besides reducing the patient's fear of cancer&#xD;
      recurrence and degree of psychological distress, compared with a doctor led follow-up&#xD;
      program. Further, nurse led follow-up by telephone, may reduce resources of the department as&#xD;
      well as of the patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background The 2015 release of a new &quot;Follow-up Program for Gynecological Cancers&quot; by the&#xD;
      Danish Health Authority (DHA) marked a break with traditional follow-up. The conclusion,&#xD;
      derived from a Health Technology Assessment report from 2009 assessing the value of follow up&#xD;
      in patients with endometrial and ovarian cancer, was, that regular follow-up visits do not&#xD;
      improve survival and may consume unnecessary resources from both patients and health care&#xD;
      personnel. As a consequence, a need based program was proposed where the follow-up is planned&#xD;
      individually and adjusted according to patient's needs, risks and resources. It was further&#xD;
      emphasized that patient's self-care ability should be supported and that access to specialist&#xD;
      assessment should be easy available.&#xD;
&#xD;
      The new follow-up program was soon implemented in most national gynecological centers without&#xD;
      previous evaluation in a pilot setting and with sparse evidence of benefits and harms.&#xD;
      Further, as the recommendations from the DHA were broad, various forms of the model were&#xD;
      introduced. Optimally, a national common professional agreement to standardize this&#xD;
      transformation should be made. However, there is neither consistency nor sufficient knowledge&#xD;
      about the optimal organizational follow-up model for gynecological cancer patients for this&#xD;
      to be accomplished.&#xD;
&#xD;
      Internationally, various follow-up models for patients with cancer have been tested over the&#xD;
      past decade. In the gynecological setting, evidence of the most optimal organization of&#xD;
      follow-up is sparse. In general, studies suggest that follow-up conducted in a nurse or&#xD;
      general practitioner setting demonstrate similar survival and recurrence detection rates and&#xD;
      similar or slightly better rates of satisfaction and quality of life as compared to follow-up&#xD;
      in a conventional setting.&#xD;
&#xD;
      From previous national studies on survivorship in Danish cancer patients it was learned&#xD;
      learned that involvement of the general practitioners (GPs) in the follow-up process was not&#xD;
      superior, and one in ten cancer patient was not satisfied with the contribution from their GP&#xD;
      during the follow-up. Further, studies have shown that socioeconomic status had a significant&#xD;
      impact on participation in rehabilitation activities of gynecological cancer patients with&#xD;
      cervical and ovarian cancer patients being especially vulnerable. Unmet needs after cancer&#xD;
      was found to be significantly associated with lower quality of life emphasizing the&#xD;
      importance of need assessment. Preliminary data from a local randomized trial of follow up&#xD;
      vs. no follow up in low risk endometrial cancer patients indicate that women report a higher&#xD;
      degree of fear of recurrence after cancer treatment if they receive no follow-up as compared&#xD;
      to a group receiving conventional follow-up. Hence, results obtained from prior studies on&#xD;
      survivorship following gynecological cancer treatment indicate that follow-up to some extent&#xD;
      seems needed and emphasize a need to develop new programs that facilitates self-management&#xD;
      but at the same time embrace those most vulnerable. Question is how the patients needs are&#xD;
      best accommodated with limited resources available. Comprehensive evaluation of effects,&#xD;
      benefits and harms are essential before implementation of new initiatives.&#xD;
&#xD;
      This randomized study suggests a strong focus on promotion of cancer patients' self-care&#xD;
      ability, in this study conceptualized as empowerment. Empowerment has been described as &quot;a&#xD;
      process by which people, organizations, and communities gain mastery over their affairs&quot; and&#xD;
      empowerment processes as &quot;processes in which attempts to gain control, obtain needed&#xD;
      resources, and critically understand one's social environment are fundamental. The process is&#xD;
      empowering if it helps people to develop skills so that they can become independent&#xD;
      problem-solvers and decision-makers&quot;. Focus on improvement of patient empowerment may thus&#xD;
      unify the need for patient involvement, promotion of self-care ability and re-allocate&#xD;
      resources to those patients most vulnerable who are often neglected in the follow-up process.&#xD;
      Further, by empowering patients to master the consequences of their cancer disease, they may&#xD;
      have fewer unmet needs, which may altogether improve quality of life and reduce fear of&#xD;
      recurrence.&#xD;
&#xD;
      Use of electronic Patient Reported Outcome Measures (ePROMs) in the follow-up process has in&#xD;
      selected populations shown to improve quality of life, reduce emergency room visits and&#xD;
      hospitalizations, and improve quality-adjusted survival. Therefore ePROMs are suggested as&#xD;
      important elements of future follow-up programs for cancer patients.&#xD;
&#xD;
      By combining nurse-led, needs based and individually planned follow-up, support of patient&#xD;
      empowerment to self-manage with use of ePROMS to provide a safe and efficient follow-up&#xD;
      program, the extended model of follow-up of the present study may improve patient outcomes&#xD;
      and reduce economic as well as human resourses.&#xD;
&#xD;
      Study design Randomized, controlled study. Patients and health care professionals are not&#xD;
      blinded, but randomization will be carried out centrally and the allocation sequence is&#xD;
      computer-generated with varying block size and is kept unknown for all investigators. In&#xD;
      addition, the patient's randomization status will be blinded during data processing and&#xD;
      analysis.&#xD;
&#xD;
      The study will be developed, implemented and results will be published in accordance with the&#xD;
      CONSORT statement.&#xD;
&#xD;
      Participants and Setting Women with cervical or endometrial cancer who are surgically treated&#xD;
      at the Department of Gynecology at Odense University Hospital (OUH) are invited to&#xD;
      participate. Women referred to oncological treatment post operative, who do not speak or read&#xD;
      Danish, or where consent is unethical, i.e. caused by dementia, are not eligible. Patients&#xD;
      will be recruited from 2019-2021.&#xD;
&#xD;
      The project is carried out by project nurses and doctors of the Department of Gynecology at&#xD;
      OUH, where inclusion of patients and follow-up are conducted. The department operates 350-400&#xD;
      gynecological cancer patients annually, of which 50-70 with cervical cancer and 160-180 with&#xD;
      endometrial cancer. Overall, about 60% (126-150 patients per year) will meet the inclusion&#xD;
      criteria.&#xD;
&#xD;
      Patients, who do not wish to participate or for other reasons are not included, are referred&#xD;
      to the doctor led follow-up program, which was implemented as the new standard during the&#xD;
      autumn of 2017.&#xD;
&#xD;
      The project group consists of clinicians and researchers from the Department of Gynecology at&#xD;
      OUH and Clinical Institute, Research Unit for General Practice, and Department of Psychology&#xD;
      at University of Southern Denmark. In addition, patient representatives from the Danish&#xD;
      &quot;Patient Association of Women with Gynecological Cancer&quot; are invited to give feedback on the&#xD;
      proposed intervention, the questionnaires and all patient materials. In addition they will be&#xD;
      asked to participate in the interpretation of the study results.&#xD;
&#xD;
      Odense Patient data Explorative Network (OPEN) which is a non-profit research infrastructure&#xD;
      of OUH and University of Southern Denmark, contribute to the management of the questionnaires&#xD;
      and data collection by using the Research Electronic Data Capture (REDCap) technology.&#xD;
      Further, OPEN provides data management assistance and statistical support.&#xD;
&#xD;
      Study plan In the present study an innovative model is tested where specialized nurses handle&#xD;
      the follow-up of endometrial and cervical cancer patients in the intervention group. The&#xD;
      model is based on telephone consultations and developed to ensure timely identification of&#xD;
      alarm symptoms and potential needs and support of the patient's empowerment to manage life&#xD;
      after cancer.&#xD;
&#xD;
      Until the intervention baseline at 4 months post operative, all patients receive the same&#xD;
      follow-up. Hence, before randomization, all patients are offered a follow-up consultation&#xD;
      with a nurse 4 weeks post operative, where a need assessment is conducted using the&#xD;
      &quot;Preparatory Form for the patient&quot; as described by the Region of Southern Denmark in their&#xD;
      &quot;Guide to need assessment of patients with cancer&quot;. Further, a disease specific list of alarm&#xD;
      symptoms prepared by working groups of the Danish Gynecological Cancer Group (DGCG) is&#xD;
      reviewed with the patient. The patient is carefully instructed to be aware of and contact the&#xD;
      department in case of symptoms from the list as they may indicate recurrence, and that access&#xD;
      to clinical examination is available and provided when needed.&#xD;
&#xD;
      All patients are eventually offered a follow-up consultation with a doctor 4 months post&#xD;
      operative, where a clinical assessment is performed and the Preparatory Form and symptom list&#xD;
      are reviewed as part of the needs assessment. If the patient meets the inclusion criteria,&#xD;
      she is asked to participate in the study and is randomized if consent is obtained. The&#xD;
      randomization status is immediately revealed. For control group patients a new appointment&#xD;
      with the doctor is arranged if needed, and for patients in the intervention group a telephone&#xD;
      follow-up with the attending nurse is arranged.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Anticipated">January 28, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</primary_completion_date>
  <phase>N/A</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Empowerment using the Health Education Impact Questionnaire (HEI-Q)</measure>
    <time_frame>Change from baseline (3 months post operative) to 12 months post operative.</time_frame>
    <description>The primary outcome is measured as change of the skill and technique acquisition subscale score of the HEI-Q from baseline to 12 months post operative. Questionnaires are administered at 3 (baseline), 12, 24 and 36 months after surgery, respectively. Change from baseline to 24 and 36 months post operative are considered as secondary outcomes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Empowerment using the Health Education Impact Questionnaire (HEI-Q)</measure>
    <time_frame>Questionnaires are administered at 3 (baseline), 12, 24 and 36 months after surgery, respectively</time_frame>
    <description>Change in other subscales of the HEI-Q from baseline to 12, 24 and 36 months post operative</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fear of cancer recurrence using the Fear of Cancer Recurrence Inventory (FCRI)</measure>
    <time_frame>Questionnaires are administered at 3 (baseline), 12, 24 and 36 months after surgery, respectively</time_frame>
    <description>Change in fear of cancer recurrence from baseline to 12, 24 and 36 months respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health related quality of life using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)</measure>
    <time_frame>Questionnaires are administered at 3 (baseline), 12, 24 and 36 months after surgery, respectively</time_frame>
    <description>Change in Global Health Status and other subscales of the C30 questionnaire from baseline to 12, 24 and 36 months respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cancer type specific quality of life using the EORTC Endometrial Cancer Module (EORTC QLQ-EN24)</measure>
    <time_frame>Questionnaires are administered at 3 (baseline), 12, 24 and 36 months after surgery, respectively</time_frame>
    <description>Change from baseline to 12, 24 and 36 months respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cancer type specific quality of life using the EORTC Cervical Cancer Module (EORTC QLQ-CX24)</measure>
    <time_frame>Questionnaires are administered at 3 (baseline), 12, 24 and 36 months after surgery, respectively</time_frame>
    <description>Change from baseline to 12, 24 and 36 months respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Status using the EuroQol five-Dimensional (EQ5D) measure</measure>
    <time_frame>Questionnaires are administered at 3 (baseline), 12, 24 and 36 months after surgery, respectively</time_frame>
    <description>Change from baseline to 12, 24 and 36 months respectively.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Empowerment, Cervical Cancer, Endometrial Cancer, Follow-up, Nurse-led, PROM</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard follow-up in doctors setting</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nurse-led follow-up with focus on empowerment and need assessment by use of ePROMS</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>NEMO: NEw MOdel of follow-up</intervention_name>
    <description>The nurse led model is built upon phone contacts with content and intervals individually planned by the nurse and the patient. The individual contacts will be supported by graphic visualisation of ePROMs in REDCap filled out by the patient before each contact including DGCG's disease specific symptom list and the generic European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) (24) supplemented with the relevant disease-specific add-on module (25, 26). The sum scores are visualised with colours to indicate severe problems (red), no problems (green) and mild or moderate problems (yellow and orange), respectively. Hence, alarm symptoms and problem areas are clearly presented to the project nurse and changes can be visualised over time enhancing the interpretation. The patient will be given access to own scoring results to obtain an understanding of the meaning of changes in health status.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  No adjuvant therapy after surgery&#xD;
&#xD;
          -  Speak and write Danish&#xD;
&#xD;
          -  Mentally capable to adapt to intervention&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Indication for adjuvant therapy after primary surgical treatment&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female genital cancer patients</gender_description>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Stinne Holm Bergholdt, PHD</last_name>
    <phone>+45 40849722</phone>
    <phone_ext>NN</phone_ext>
    <email>stinne.holm.bergholdt@rsyd.dk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Gynecology, Odense University Hospital</name>
      <address>
        <city>Odense</city>
        <state>Region Of Southern Denmark</state>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stinne Holm Bergholdt, PHD</last_name>
      <phone>+45 40849722</phone>
      <phone_ext>NN</phone_ext>
      <email>stinne.holm.bergholdt@rsyd.dk</email>
    </contact>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>February 6, 2019</study_first_submitted>
  <study_first_submitted_qc>February 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>April 21, 2022</last_update_submitted>
  <last_update_submitted_qc>April 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern Denmark</investigator_affiliation>
    <investigator_full_name>Stinne Holm Bergholdt</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometrial Neoplasms</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/NCT03838861
org study id: Stinne1977
nct id: NCT03838861
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This randomized controlled trial is testing the hypothesis that an individually focused and
      need-based nurse led follow-up program supported by electronic Patient Reported Outcome
      Measures for women with gynecological cancer will improve patient's empowerment, quality of
      life and involvement in the follow-up process besides reducing the patient's fear of cancer
      recurrence and degree of psychological distress, compared with a doctor led follow-up
      program. Further, nurse led follow-up by telephone, may reduce resources of the department as
      well as of the patients.
Background The 2015 release of a new "Follow-up Program for Gynecological Cancers" by the
      Danish Health Authority (DHA) marked a break with traditional follow-up. The conclusion,
      derived from a Health Technology Assessment report from 2009 assessing the value of follow up
      in patients with endometrial and ovarian cancer, was, that regular follow-up visits do not
      improve survival and may consume unnecessary resources from both patients and health care
      personnel. As a consequence, a need based program was proposed where the follow-up is planned
      individually and adjusted according to patient's needs, risks and resources. It was further
      emphasized that patient's self-care ability should be supported and that access to specialist
      assessment should be easy available.

      The new follow-up program was soon implemented in most national gynecological centers without
      previous evaluation in a pilot setting and with sparse evidence of benefits and harms.
      Further, as the recommendations from the DHA were broad, various forms of the model were
      introduced. Optimally, a national common professional agreement to standardize this
      transformation should be made. However, there is neither consistency nor sufficient knowledge
      about the optimal organizational follow-up model for gynecological cancer patients for this
      to be accomplished.

      Internationally, various follow-up models for patients with cancer have been tested over the
      past decade. In the gynecological setting, evidence of the most optimal organization of
      follow-up is sparse. In general, studies suggest that follow-up conducted in a nurse or
      general practitioner setting demonstrate similar survival and recurrence detection rates and
      similar or slightly better rates of satisfaction and quality of life as compared to follow-up
      in a conventional setting.

      From previous national studies on survivorship in Danish cancer patients it was learned
      learned that involvement of the general practitioners (GPs) in the follow-up process was not
      superior, and one in ten cancer patient was not satisfied with the contribution from their GP
      during the follow-up. Further, studies have shown that socioeconomic status had a significant
      impact on participation in rehabilitation activities of gynecological cancer patients with
      cervical and ovarian cancer patients being especially vulnerable. Unmet needs after cancer
      was found to be significantly associated with lower quality of life emphasizing the
      importance of need assessment. Preliminary data from a local randomized trial of follow up
      vs. no follow up in low risk endometrial cancer patients indicate that women report a higher
      degree of fear of recurrence after cancer treatment if they receive no follow-up as compared
      to a group receiving conventional follow-up. Hence, results obtained from prior studies on
      survivorship following gynecological cancer treatment indicate that follow-up to some extent
      seems needed and emphasize a need to develop new programs that facilitates self-management
      but at the same time embrace those most vulnerable. Question is how the patients needs are
      best accommodated with limited resources available. Comprehensive evaluation of effects,
      benefits and harms are essential before implementation of new initiatives.

      This randomized study suggests a strong focus on promotion of cancer patients' self-care
      ability, in this study conceptualized as empowerment. Empowerment has been described as "a
      process by which people, organizations, and communities gain mastery over their affairs" and
      empowerment processes as "processes in which attempts to gain control, obtain needed
      resources, and critically understand one's social environment are fundamental. The process is
      empowering if it helps people to develop skills so that they can become independent
      problem-solvers and decision-makers". Focus on improvement of patient empowerment may thus
      unify the need for patient involvement, promotion of self-care ability and re-allocate
      resources to those patients most vulnerable who are often neglected in the follow-up process.
      Further, by empowering patients to master the consequences of their cancer disease, they may
      have fewer unmet needs, which may altogether improve quality of life and reduce fear of
      recurrence.

      Use of electronic Patient Reported Outcome Measures (ePROMs) in the follow-up process has in
      selected populations shown to improve quality of life, reduce emergency room visits and
      hospitalizations, and improve quality-adjusted survival. Therefore ePROMs are suggested as
      important elements of future follow-up programs for cancer patients.

      By combining nurse-led, needs based and individually planned follow-up, support of patient
      empowerment to self-manage with use of ePROMS to provide a safe and efficient follow-up
      program, the extended model of follow-up of the present study may improve patient outcomes
      and reduce economic as well as human resourses.

      Study design Randomized, controlled study. Patients and health care professionals are not
      blinded, but randomization will be carried out centrally and the allocation sequence is
      computer-generated with varying block size and is kept unknown for all investigators. In
      addition, the patient's randomization status will be blinded during data processing and
      analysis.

      The study will be developed, implemented and results will be published in accordance with the
      CONSORT statement.

      Participants and Setting Women with cervical or endometrial cancer who are surgically treated
      at the Department of Gynecology at Odense University Hospital (OUH) are invited to
      participate. Women referred to oncological treatment post operative, who do not speak or read
      Danish, or where consent is unethical, i.e. caused by dementia, are not eligible. Patients
      will be recruited from 2019-2021.

      The project is carried out by project nurses and doctors of the Department of Gynecology at
      OUH, where inclusion of patients and follow-up are conducted. The department operates 350-400
      gynecological cancer patients annually, of which 50-70 with cervical cancer and 160-180 with
      endometrial cancer. Overall, about 60% (126-150 patients per year) will meet the inclusion
      criteria.

      Patients, who do not wish to participate or for other reasons are not included, are referred
      to the doctor led follow-up program, which was implemented as the new standard during the
      autumn of 2017.

      The project group consists of clinicians and researchers from the Department of Gynecology at
      OUH and Clinical Institute, Research Unit for General Practice, and Department of Psychology
      at University of Southern Denmark. In addition, patient representatives from the Danish
      "Patient Association of Women with Gynecological Cancer" are invited to give feedback on the
      proposed intervention, the questionnaires and all patient materials. In addition they will be
      asked to participate in the interpretation of the study results.

      Odense Patient data Explorative Network (OPEN) which is a non-profit research infrastructure
      of OUH and University of Southern Denmark, contribute to the management of the questionnaires
      and data collection by using the Research Electronic Data Capture (REDCap) technology.
      Further, OPEN provides data management assistance and statistical support.

      Study plan In the present study an innovative model is tested where specialized nurses handle
      the follow-up of endometrial and cervical cancer patients in the intervention group. The
      model is based on telephone consultations and developed to ensure timely identification of
      alarm symptoms and potential needs and support of the patient's empowerment to manage life
      after cancer.

      Until the intervention baseline at 4 months post operative, all patients receive the same
      follow-up. Hence, before randomization, all patients are offered a follow-up consultation
      with a nurse 4 weeks post operative, where a need assessment is conducted using the
      "Preparatory Form for the patient" as described by the Region of Southern Denmark in their
      "Guide to need assessment of patients with cancer". Further, a disease specific list of alarm
      symptoms prepared by working groups of the Danish Gynecological Cancer Group (DGCG) is
      reviewed with the patient. The patient is carefully instructed to be aware of and contact the
      department in case of symptoms from the list as they may indicate recurrence, and that access
      to clinical examination is available and provided when needed.

      All patients are eventually offered a follow-up consultation with a doctor 4 months post
      operative, where a clinical assessment is performed and the Preparatory Form and symptom list
      are reviewed as part of the needs assessment. If the patient meets the inclusion criteria,
      she is asked to participate in the study and is randomized if consent is obtained. The
      randomization status is immediately revealed. For control group patients a new appointment
      with the doctor is arranged if needed, and for patients in the intervention group a telephone
      follow-up with the attending nurse is arranged.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Investigator, Outcomes Assessor)
measure: Patient Empowerment using the Health Education Impact Questionnaire (HEI-Q)
time frame: Change from baseline (3 months post operative) to 12 months post operative.
description: The primary outcome is measured as change of the skill and technique acquisition subscale score of the HEI-Q from baseline to 12 months post operative. Questionnaires are administered at 3 (baseline), 12, 24 and 36 months after surgery, respectively. Change from baseline to 24 and 36 months post operative are considered as secondary outcomes.
measure: Patient Empowerment using the Health Education Impact Questionnaire (HEI-Q)
time frame: Questionnaires are administered at 3 (baseline), 12, 24 and 36 months after surgery, respectively
description: Change in other subscales of the HEI-Q from baseline to 12, 24 and 36 months post operative
measure: Fear of cancer recurrence using the Fear of Cancer Recurrence Inventory (FCRI)
time frame: Questionnaires are administered at 3 (baseline), 12, 24 and 36 months after surgery, respectively
description: Change in fear of cancer recurrence from baseline to 12, 24 and 36 months respectively.
measure: Health related quality of life using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
time frame: Questionnaires are administered at 3 (baseline), 12, 24 and 36 months after surgery, respectively
description: Change in Global Health Status and other subscales of the C30 questionnaire from baseline to 12, 24 and 36 months respectively.
measure: Cancer type specific quality of life using the EORTC Endometrial Cancer Module (EORTC QLQ-EN24)
time frame: Questionnaires are administered at 3 (baseline), 12, 24 and 36 months after surgery, respectively
description: Change from baseline to 12, 24 and 36 months respectively.
measure: Cancer type specific quality of life using the EORTC Cervical Cancer Module (EORTC QLQ-CX24)
time frame: Questionnaires are administered at 3 (baseline), 12, 24 and 36 months after surgery, respectively
description: Change from baseline to 12, 24 and 36 months respectively.
measure: Health Status using the EuroQol five-Dimensional (EQ5D) measure
time frame: Questionnaires are administered at 3 (baseline), 12, 24 and 36 months after surgery, respectively
description: Change from baseline to 12, 24 and 36 months respectively.
arm group label: Control
arm group type: Active Comparator
description: Standard follow-up in doctors setting
arm group label: Intervention
arm group type: Experimental
description: Nurse-led follow-up with focus on empowerment and need assessment by use of ePROMS
intervention type: Behavioral
intervention name: NEMO: NEw MOdel of follow-up
description: The nurse led model is built upon phone contacts with content and intervals individually planned by the nurse and the patient. The individual contacts will be supported by graphic visualisation of ePROMs in REDCap filled out by the patient before each contact including DGCG's disease specific symptom list and the generic European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) (24) supplemented with the relevant disease-specific add-on module (25, 26). The sum scores are visualised with colours to indicate severe problems (red), no problems (green) and mild or moderate problems (yellow and orange), respectively. Hence, alarm symptoms and problem areas are clearly presented to the project nurse and changes can be visualised over time enhancing the interpretation. The patient will be given access to own scoring results to obtain an understanding of the meaning of changes in health status.
arm group label: Control
arm group label: Intervention
criteria: 
gender: Female
gender based: Yes
gender description: Female genital cancer patients
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Stinne Holm Bergholdt, PHD
phone: +45 40849722
phone ext: NN
email: stinne.holm.bergholdt@rsyd.dk
facility: 
status: Recruiting
contact: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: University of Southern Denmark
investigator full name: Stinne Holm Bergholdt
investigator title: Principal Investigator
mesh term: Endometrial Neoplasms