<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/NCT01718574</url>
  </required_header>
  <id_info>
    <org_study_id>2888</org_study_id>
    <nct_id>NCT01718574</nct_id>
  </id_info>
  <brief_title>Bibliotherapy for Patients With Cancer</brief_title>
  <official_title>Feasibility, Acceptability and Efficacy of Bibliotherapy for Patients With Cancer: a Randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McGill University Health Centre/Research Institute of the McGill University Health Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cedars CanSupport, Hope &amp; Cope</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>McGill University Health Centre/Research Institute of the McGill University Health Centre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to examine the efficacy of a self-help workbook in enhancing a&#xD;
      sense of empowerment, coping, quality of life and reducing distress for patients with cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2013</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in Health Education Impact Questionnaire scores</measure>
    <time_frame>pre-intervention (week 0), post intervention (week 6), follow-up (week 10)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in Ways of Coping Questionnaire - Cancer Version &amp; Hospital Anxiety and Depression Scale scores</measure>
    <time_frame>pre-intervention (week 0), post intervention (week 6), follow-up (week 10)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">89</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Self-help book</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Self-help book</intervention_name>
    <description>Participants have 6 weeks to complete a 12 chapter self-help workbook. The workbook addresses: (i) The enhancement of a sense of personal control; and (ii) The learning of emotional and instrumental coping responses</description>
    <arm_group_label>Self-help book</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18+ years of age&#xD;
&#xD;
          -  been diagnosed with cancer&#xD;
&#xD;
          -  can read English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -participating in the &quot;Think Smart, Live Well&quot; group&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>MUHC Cedars CanSupport</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3A 1A1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hope &amp; Cope, JGH</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>October 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <last_update_submitted>September 5, 2014</last_update_submitted>
  <last_update_submitted_qc>September 5, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 9, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>McGill University Health Centre/Research Institute of the McGill University Health Centre</investigator_affiliation>
    <investigator_full_name>Dr. Annett Korner, PhD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>self-help book</keyword>
  <keyword>support service</keyword>
  <!-- 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/NCT01718574
org study id: 2888
nct id: NCT01718574
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to examine the efficacy of a self-help workbook in enhancing a
      sense of empowerment, coping, quality of life and reducing distress for patients with cancer.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: change in Health Education Impact Questionnaire scores
time frame: pre-intervention (week 0), post intervention (week 6), follow-up (week 10)
measure: change in Ways of Coping Questionnaire - Cancer Version & Hospital Anxiety and Depression Scale scores
time frame: pre-intervention (week 0), post intervention (week 6), follow-up (week 10)
arm group label: Self-help book
arm group type: Experimental
arm group label: Usual Care Control
arm group type: No Intervention
intervention type: Other
intervention name: Self-help book
description: Participants have 6 weeks to complete a 12 chapter self-help workbook. The workbook addresses: (i) The enhancement of a sense of personal control; and (ii) The learning of emotional and instrumental coping responses
arm group label: Self-help book
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
investigator full name: Dr. Annett Korner, PhD
investigator title: Principal Investigator