<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/NCT01699672</url>
  </required_header>
  <id_info>
    <org_study_id>REK2012/1238</org_study_id>
    <nct_id>NCT01699672</nct_id>
  </id_info>
  <brief_title>Group-based or Individual Information About Disease and Treatment Plan</brief_title>
  <official_title>Cancer Patients' Knowledge and Satisfaction After Group-based or Individual Information About Their Disease and Treatment Plan</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Norwegian University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>St. Olavs Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Norwegian University of Science and Technology</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main aim of the current study is to investigate whether the addition of a&#xD;
      standardized,group-based educational program to the information provided by health care&#xD;
      personnel improves cancer patients' knowledge level about their disease, planned treatment&#xD;
      and common side-effects of the treatment.&#xD;
&#xD;
      Secondary aims are to investigate if the addition of the educational program increases the&#xD;
      likelihood of completing treatment as planned, reduces level of anxiety, reduces the&#xD;
      frequency of serious side effects, increases patient reported health related quality of life,&#xD;
      and increases the degree of patient satisfaction with respect to how they have received the&#xD;
      information before, during and after treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There are strong indications that group-based information provides better information for&#xD;
      cancer patients about their disease, treatment options - and potential benefits and side&#xD;
      effects of the planned therapy than information provided during a regular doctor&#xD;
      consultation.&#xD;
&#xD;
      The investigators believe that standardizing and repeating the information as well as having&#xD;
      more time for questions in an open environment for reflections will improve the amount of&#xD;
      information patients can perceive. Furthermore, all patients will be given written&#xD;
      information.&#xD;
&#xD;
      Better-informed patients may be more motivated and may contact health care personnel earlier&#xD;
      than other patients when they develop side effects. This may reduce the risk of serious&#xD;
      treatment-related complications and increase the chances of patients completing the planned&#xD;
      treatment. But none have compared to what extent an organization like Vardesenteret improves&#xD;
      the patients' knowledge and whether patients are more satisfied with these methods for&#xD;
      informing them. Results from studies on the influence of patient anxiety and distress on&#xD;
      patient's abilities to perceive information are conflicting.Two large groups of relatively&#xD;
      homogenous cancer patients are patients with lower-stage breast cancer patients who are&#xD;
      eligible for adjuvant chemotherapy and patients with localized prostate cancer eligible for&#xD;
      curative radiotherapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Problems recruiting patients (not willing, travel time, no respons)&#xD;
  </why_stopped>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Knowledge</measure>
    <time_frame>1 week</time_frame>
    <description>Knowledge questionnaires specially made for the study. Constructed as statements with response categories; correct, false and don´t know.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knowledge</measure>
    <time_frame>2 weeks</time_frame>
    <description>Knowledge questionnaires specially made for the study. Constructed as statements with response categories; correct, false and don´t know.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knowledge</measure>
    <time_frame>9 weeks</time_frame>
    <description>Knowledge questionnaires specially made for the study. Constructed as statements with response categories; correct, false and don´t know.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>9 weeks</time_frame>
    <description>European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire C30</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients Subjective state of information</measure>
    <time_frame>1 week</time_frame>
    <description>European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire INFO 25</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients Subjective state of information</measure>
    <time_frame>2 weeks</time_frame>
    <description>European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire INFO 25</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients Subjective state of information</measure>
    <time_frame>9 weeks</time_frame>
    <description>European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire INFO 25</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>1 week</time_frame>
    <description>STAI-State and Trait Anxiety Inventory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>2 weeks</time_frame>
    <description>STAI-State and Trait Anxiety Inventory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>9 weeks</time_frame>
    <description>STAI-State and Trait Anxiety Inventory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>2 weeks</time_frame>
    <description>CTCEA, Common Terminology Criteria for Adverse Events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>9 weeks</time_frame>
    <description>CTCEA, Common Terminology Criteria for Adverse Events</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">98</enrollment>
  <condition>Prostate Cancer</condition>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Group and Individual information</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients will receive two 1.5-2 hour standardized validated group information sessions in addition to regular information from their doctors and nurses.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Individual information</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard information about disease and treatment from doctor and nurse given at 2 occasions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Group information</intervention_name>
    <description>The patients will receive two 1.5-2 hour standardized validated group information sessions in addition to regular information from their doctors and nurses.</description>
    <arm_group_label>Group and Individual information</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Breast cancer patients that are candidates for adjuvant chemotherapy after surgery.&#xD;
&#xD;
          -  Prostate cancer patients that are candidates for curative radiotherapy&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
          -  Patient expected to be able to complete the planned treatment and the study procedures&#xD;
&#xD;
          -  18years or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -Patients not fulfilling inclusion criteria&#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>Stein Kaasa, MD, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ola Berger, MD</last_name>
    <role>Study Director</role>
    <affiliation>St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bjørn H Gønberg, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kari Sand, Cand Philol</last_name>
    <role>Study Chair</role>
    <affiliation>PRC, European Palliative Care Research Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jo Å Lund, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jon H Loge, MD, Prof.</last_name>
    <role>Study Chair</role>
    <affiliation>National Resource Centre for Studies of Late Effects after Cancer Treatment, Oslo University Hospital, Radiumhospitalet, Oslo, Norway; Department of Behavioral Sciences in Medicine, University of Oslo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St Olavs Hospital</name>
      <address>
        <city>Trondheim</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>September 21, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>January 25, 2017</last_update_submitted>
  <last_update_submitted_qc>January 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Patient education</keyword>
  <keyword>information</keyword>
  <keyword>communication</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic 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/NCT01699672
org study id: REK2012/1238
nct id: NCT01699672
lead sponsor: 
collaborator: 
has dmc: No
The main aim of the current study is to investigate whether the addition of a
      standardized,group-based educational program to the information provided by health care
      personnel improves cancer patients' knowledge level about their disease, planned treatment
      and common side-effects of the treatment.

      Secondary aims are to investigate if the addition of the educational program increases the
      likelihood of completing treatment as planned, reduces level of anxiety, reduces the
      frequency of serious side effects, increases patient reported health related quality of life,
      and increases the degree of patient satisfaction with respect to how they have received the
      information before, during and after treatment.
There are strong indications that group-based information provides better information for
      cancer patients about their disease, treatment options - and potential benefits and side
      effects of the planned therapy than information provided during a regular doctor
      consultation.

      The investigators believe that standardizing and repeating the information as well as having
      more time for questions in an open environment for reflections will improve the amount of
      information patients can perceive. Furthermore, all patients will be given written
      information.

      Better-informed patients may be more motivated and may contact health care personnel earlier
      than other patients when they develop side effects. This may reduce the risk of serious
      treatment-related complications and increase the chances of patients completing the planned
      treatment. But none have compared to what extent an organization like Vardesenteret improves
      the patients' knowledge and whether patients are more satisfied with these methods for
      informing them. Results from studies on the influence of patient anxiety and distress on
      patient's abilities to perceive information are conflicting.Two large groups of relatively
      homogenous cancer patients are patients with lower-stage breast cancer patients who are
      eligible for adjuvant chemotherapy and patients with localized prostate cancer eligible for
      curative radiotherapy.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Knowledge
time frame: 1 week
description: Knowledge questionnaires specially made for the study. Constructed as statements with response categories; correct, false and don´t know.
measure: Knowledge
time frame: 2 weeks
description: Knowledge questionnaires specially made for the study. Constructed as statements with response categories; correct, false and don´t know.
measure: Knowledge
time frame: 9 weeks
description: Knowledge questionnaires specially made for the study. Constructed as statements with response categories; correct, false and don´t know.
measure: Quality of Life
time frame: 9 weeks
description: European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire C30
measure: Patients Subjective state of information
time frame: 1 week
description: European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire INFO 25
measure: Patients Subjective state of information
time frame: 2 weeks
description: European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire INFO 25
measure: Patients Subjective state of information
time frame: 9 weeks
description: European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire INFO 25
measure: Anxiety
time frame: 1 week
description: STAI-State and Trait Anxiety Inventory
measure: Anxiety
time frame: 2 weeks
description: STAI-State and Trait Anxiety Inventory
measure: Anxiety
time frame: 9 weeks
description: STAI-State and Trait Anxiety Inventory
measure: Adverse events
time frame: 2 weeks
description: CTCEA, Common Terminology Criteria for Adverse Events
measure: Adverse events
time frame: 9 weeks
description: CTCEA, Common Terminology Criteria for Adverse Events
arm group label: Group and Individual information
arm group type: Experimental
description: The patients will receive two 1.5-2 hour standardized validated group information sessions in addition to regular information from their doctors and nurses.
arm group label: Individual information
arm group type: No Intervention
description: Standard information about disease and treatment from doctor and nurse given at 2 occasions.
intervention type: Other
intervention name: Group information
description: The patients will receive two 1.5-2 hour standardized validated group information sessions in addition to regular information from their doctors and nurses.
arm group label: Group and Individual information
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stein Kaasa, MD, Prof.
role: Principal Investigator
affiliation: St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center
last name: Ola Berger, MD
role: Study Director
affiliation: St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center
last name: Bjørn H Gønberg, MD, PhD
role: Study Chair
affiliation: St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center
last name: Kari Sand, Cand Philol
role: Study Chair
affiliation: PRC, European Palliative Care Research Center
last name: Jo Å Lund, MD, PhD
role: Study Chair
affiliation: St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center
last name: Jon H Loge, MD, Prof.
role: Study Chair
affiliation: National Resource Centre for Studies of Late Effects after Cancer Treatment, Oslo University Hospital, Radiumhospitalet, Oslo, Norway; Department of Behavioral Sciences in Medicine, University of Oslo
facility: 
country: Norway
responsible party type: Sponsor
mesh term: Prostatic Neoplasms