<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/NCT01691144</url>
  </required_header>
  <id_info>
    <org_study_id>2012/355B</org_study_id>
    <nct_id>NCT01691144</nct_id>
  </id_info>
  <brief_title>Follow-up of Gynecological Cancer Patients, Their Needs and Expectations, A Cooperation Project</brief_title>
  <official_title>Gynecological Cancer Survivors' Views on Follow-up After Cancer Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oslo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Oslo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Follow-up of cancer patients accounts for a substantial part of outpatient activity, and&#xD;
      alternative models of care are developing. In some countries, low-risk follow-up is already&#xD;
      done in primary care, mainly in breast, and colorectal cancer. In this study the&#xD;
      investigators will explore gynecological cancer patients about their expectations regarding&#xD;
      their future follow-up plan. Further, the investigators will ask about the experience and&#xD;
      satisfaction among patients who have already attended a follow-up programme for 2-3 years. In&#xD;
      addition, the investigators will especially focus on the cooperation aspect between primary&#xD;
      and secondary care. The investigators hypothesize that follow-up of selected gynecological&#xD;
      cancer patients can be done by general practitioners.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After gynaecological cancer patients have completed their treatment, they are followed up at&#xD;
      a gynaecological outpatient clinic for a number of years. The aim of such follow-up is to&#xD;
      detect recurrence, improve survival and reduce adverse effects of the treatment. The national&#xD;
      guide for oncological gynaecology recommends follow-up by a specialist for five years at&#xD;
      intervals depending on cancer type. Several review studies on follow-up of endometrial,&#xD;
      cervical and ovarian cancer patients show large international variations in follow-up&#xD;
      routines. There are only retrospective studies available, and they indicate that most&#xD;
      recurrences are discovered within the first three years after completed treatment, and, in&#xD;
      most cases, by the women themselves. More intensive surveillance does not appear to affect&#xD;
      the time for discovery of recurrence.&#xD;
&#xD;
      A few randomised controlled studies and retrospective cohort studies have been published that&#xD;
      focus on follow-up of colon cancer and breast cancer patients by general practitioners versus&#xD;
      by hospital specialists. These studies have not shown any significant differences between the&#xD;
      groups in terms of detection of recurrence, incidence of serious clinical events connected&#xD;
      with recurrence or health-related quality of life.&#xD;
&#xD;
      The investigators therefore plan to perform a study in which both gynaecological cancer&#xD;
      patients and their regular general practitioners are asked about their views on patient&#xD;
      follow-up after completed treatment. The investigators especially wish to focus on the&#xD;
      collaboration aspect.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Patient expectation questionnaire</measure>
    <time_frame>within the first 30 days after primary treatment</time_frame>
    <description>The patients will be asked to fill in a quesionnaire regarding their expectations on follow-up care</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction questionnaire</measure>
    <time_frame>3 years after treatment</time_frame>
    <description>The patients will be asked to fill in a quesionnaire regarding their satisfaction on follow-up care after three years</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">239</enrollment>
  <condition>Endometrial Cancer</condition>
  <condition>Ovarian Cancer</condition>
  <condition>Cervical Cancer</condition>
  <arm_group>
    <arm_group_label>recently treated patients</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>2-3 years after treatment</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Newly treated gynecological cancer patients and patients treated 2-3 years ago&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt; 18 years&#xD;
&#xD;
          -  histologically or cytologically proven cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unability to fill out questionnaires (due to language or cognitive barriers)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mette Brekke, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Oslo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sorlandet Hospital Kristiansand</name>
      <address>
        <city>Kristiansand</city>
        <zip>4621</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Olavs Hospital</name>
      <address>
        <city>Trondheim</city>
        <zip>7030</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <reference>
    <citation>Vistad I, Moy BW, Salvesen HB, Liavaag AH. Follow-up routines in gynecological cancer - time for a change? Acta Obstet Gynecol Scand. 2011 Jul;90(7):707-18. doi: 10.1111/j.1600-0412.2011.01123.x. Epub 2011 Apr 15.</citation>
    <PMID>21382018</PMID>
  </reference>
  <reference>
    <citation>Vistad I, Cvancarova M, Salvesen HB. Follow-up of gynecological cancer patients after treatment - the views of European experts in gynecologic oncology. Acta Obstet Gynecol Scand. 2012 Nov;91(11):1286-92. doi: 10.1111/j.1600-0412.2012.01523.x. Epub 2012 Sep 18.</citation>
    <PMID>22880840</PMID>
  </reference>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>August 15, 2012</study_first_submitted>
  <study_first_submitted_qc>September 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <last_update_submitted>May 11, 2016</last_update_submitted>
  <last_update_submitted_qc>May 11, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 12, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Oslo</investigator_affiliation>
    <investigator_full_name>Heidi Lidal Fidjeland</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>cancer</keyword>
  <keyword>gynecological</keyword>
  <keyword>expectations</keyword>
  <keyword>satisfaction</keyword>
  <keyword>cooperation</keyword>
  <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/NCT01691144
org study id: 2012/355B
nct id: NCT01691144
lead sponsor: 
has dmc: No
Follow-up of cancer patients accounts for a substantial part of outpatient activity, and
      alternative models of care are developing. In some countries, low-risk follow-up is already
      done in primary care, mainly in breast, and colorectal cancer. In this study the
      investigators will explore gynecological cancer patients about their expectations regarding
      their future follow-up plan. Further, the investigators will ask about the experience and
      satisfaction among patients who have already attended a follow-up programme for 2-3 years. In
      addition, the investigators will especially focus on the cooperation aspect between primary
      and secondary care. The investigators hypothesize that follow-up of selected gynecological
      cancer patients can be done by general practitioners.
After gynaecological cancer patients have completed their treatment, they are followed up at
      a gynaecological outpatient clinic for a number of years. The aim of such follow-up is to
      detect recurrence, improve survival and reduce adverse effects of the treatment. The national
      guide for oncological gynaecology recommends follow-up by a specialist for five years at
      intervals depending on cancer type. Several review studies on follow-up of endometrial,
      cervical and ovarian cancer patients show large international variations in follow-up
      routines. There are only retrospective studies available, and they indicate that most
      recurrences are discovered within the first three years after completed treatment, and, in
      most cases, by the women themselves. More intensive surveillance does not appear to affect
      the time for discovery of recurrence.

      A few randomised controlled studies and retrospective cohort studies have been published that
      focus on follow-up of colon cancer and breast cancer patients by general practitioners versus
      by hospital specialists. These studies have not shown any significant differences between the
      groups in terms of detection of recurrence, incidence of serious clinical events connected
      with recurrence or health-related quality of life.

      The investigators therefore plan to perform a study in which both gynaecological cancer
      patients and their regular general practitioners are asked about their views on patient
      follow-up after completed treatment. The investigators especially wish to focus on the
      collaboration aspect.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Patient expectation questionnaire
time frame: within the first 30 days after primary treatment
description: The patients will be asked to fill in a quesionnaire regarding their expectations on follow-up care
measure: Patient satisfaction questionnaire
time frame: 3 years after treatment
description: The patients will be asked to fill in a quesionnaire regarding their satisfaction on follow-up care after three years
arm group label: recently treated patients
arm group label: 2-3 years after treatment
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Mette Brekke, PhD
role: Study Chair
affiliation: University of Oslo
facility: 
facility: 
country: Norway
citation: Vistad I, Moy BW, Salvesen HB, Liavaag AH. Follow-up routines in gynecological cancer - time for a change? Acta Obstet Gynecol Scand. 2011 Jul;90(7):707-18. doi: 10.1111/j.1600-0412.2011.01123.x. Epub 2011 Apr 15.
PMID: 21382018
citation: Vistad I, Cvancarova M, Salvesen HB. Follow-up of gynecological cancer patients after treatment - the views of European experts in gynecologic oncology. Acta Obstet Gynecol Scand. 2012 Nov;91(11):1286-92. doi: 10.1111/j.1600-0412.2012.01523.x. Epub 2012 Sep 18.
PMID: 22880840
responsible party type: Principal Investigator
investigator affiliation: University of Oslo
investigator full name: Heidi Lidal Fidjeland
investigator title: MD
mesh term: Endometrial Neoplasms