<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/NCT02224482</url>
  </required_header>
  <id_info>
    <org_study_id>1R01CA158019</org_study_id>
    <secondary_id>R01CA158019</secondary_id>
    <nct_id>NCT02224482</nct_id>
  </id_info>
  <brief_title>Trial of an Online Multimedia Program to Boost Coping &amp; Function for Prostate Cancer Survivors (PROGRESS)</brief_title>
  <acronym>PROGRESS</acronym>
  <official_title>Randomized Clinical Trial of an Online Multimedia Program to Boost Coping &amp; Function for Prostate Cancer Survivors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fox Chase Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Fox Chase Cancer Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to test how well an online program designed to help prostate&#xD;
      cancer survivors cope with changes caused by their cancer or treatment works compared to&#xD;
      standard print educational materials from the National Cancer Institute (NCI).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study involves the development and evaluation of a comprehensive and innovative&#xD;
      multimedia program designed to facilitate the post-treatment transition into survivorship.&#xD;
      The design of the intervention, the PRostate Cancer Online Guide and Resources for Electronic&#xD;
      Survivorship Service (PROGRESS), is theoretically based on the team's Cognitive-Social Health&#xD;
      Information Processing Model.&#xD;
&#xD;
      PROGRESS focuses on promoting adaptive coping within four key post-treatment domains: 1)&#xD;
      Physical Dysfunction (e.g., physical symptoms); 2) Emotional Well- Being (e.g., fear of&#xD;
      recurrence); 3) Interpersonal Concerns (e.g., sexual intimacy issues); and 4) Practical&#xD;
      Barriers (e.g., medical follow-up challenges). Content for these domains are organized in a&#xD;
      virtual resource center and will consist of: 1) provision of related information through&#xD;
      text, graphics, voice overs, and animation; 2) videos of health care experts answering&#xD;
      frequently asked questions; 3) videos of prostate cancer survivors describing their&#xD;
      experiences and modeling competencies and coping strategies; and 4) skills training to&#xD;
      improve communication between prostate cancer survivors and family and healthcare providers.&#xD;
      Program content has been developed through literature and evidence-based content review,&#xD;
      expert input, and input from multi-ethnic survivor focus groups. To ensure adequate and&#xD;
      appropriate program content and optimal functionality, an iterative process of review,&#xD;
      revision, and user and usability testing has been employed.&#xD;
&#xD;
      Intervention efficacy will be evaluated through a two-arm, prospective randomized controlled&#xD;
      trial. A total of 600 patients (200 from Fox Chase Cancer Center, 200 from the Cancer&#xD;
      Institute of New Jersey, and 200 from Icahn School of Medicine at Mount Sinai) will complete&#xD;
      the study. Data will be collected at baseline, and at 1-, 3- and 6- months follow-up.&#xD;
&#xD;
      The primary outcome variable will be use of adaptive coping, and secondary outcome variables&#xD;
      will include use of maladaptive coping, disease-specific quality of life, vitality/energy,&#xD;
      physical quality of life, cancer-related intrusive thoughts, emotional quality of life, fear&#xD;
      of recurrence, bother from physical dysfunctions, satisfaction with communication in medical&#xD;
      interactions, satisfaction with cancer-related with family/friends, marital problems, and&#xD;
      practical concerns . A theory-based test of mediators of intervention effects (i.e.,&#xD;
      self-efficacy for the survivorship phase, confidence in ability to manage symptoms related to&#xD;
      prostate cancer, perceived information utility), and moderators (i.e., demographics, comorbid&#xD;
      conditions, monitoring style, affect) will also be performed.&#xD;
&#xD;
      The proposed research will be the first Randomized Controlled Trial to evaluate a&#xD;
      comprehensive and highly disseminable and self-sustaining intervention for facilitating&#xD;
      post-treatment adaptation among early-stage Pca survivors. In addition, use of and usability,&#xD;
      accessibility, and satisfaction with PROGRESS will be assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2012</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</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 (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adaptive Coping</measure>
    <time_frame>Change in coping from baseline to six months</time_frame>
    <description>Adaptive coping was measured with the Cancer Coping Questionnaire. The total score from the Cancer Coping Questionnaire is a mean scale. There were a total of 14 items, each with a Likert-type 4-point scale, with 1 being the minimum value and 4 being the maximum value. A higher score indicated greater coping ability (i.e., better outcome).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physical Functioning - Urinary Incontinence</measure>
    <time_frame>Change from baseline to six months</time_frame>
    <description>This will be measured using the Urinary Incontinence Scale from the Expanded Prostate Cancer Index Composite - Short Form (EPIC 26-SF), a 26 item shortened version of EPIC, a 61 item questionnaire for assessing urinary, bowel, sexual, and hormonal dysfunction and distress/bother in prostate cancer patients. The scale had four items, each with a Likert-type 4- or 5-item scale, with 1 being the minimum and 4 or 5 being the maximum. These scores were then recoded to a 0 to 100 scale, with higher scores indicating less urinary incontinence (i.e., better outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Functioning - Urinary Irritation</measure>
    <time_frame>Change from baseline to six months</time_frame>
    <description>This will be measured using the Urinary Irritation Scale from the Expanded Prostate Cancer Index Composite - Short Form (EPIC 26-SF), a 26 item shortened version of EPIC, a 61 item questionnaire for assessing urinary, bowel, sexual, and hormonal dysfunction and distress/bother in prostate cancer patients. The scale had four items, each with a Likert-type 4- or 5-item scale, with 1 being the minimum and 4 or 5 being the maximum. These scores were then recoded to a 0 to 100 scale, with higher scores indicating less urinary irritation (i.e., better outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Functioning - Bowel</measure>
    <time_frame>Change from baseline to six months</time_frame>
    <description>This will be measured using the Bowel Scale from the Expanded Prostate Cancer Index Composite - Short Form (EPIC 26-SF), a 26 item shortened version of EPIC, a 61 item questionnaire for assessing urinary, bowel, sexual, and hormonal dysfunction and distress/bother in prostate cancer patients. The scale had six items, each with a Likert-type 4- or 5-item scale, with 1 being the minimum and 4 or 5 being the maximum. These scores were then recoded to a 0 to 100 scale, with higher scores indicating less bowel problems (i.e., better outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Functioning - Sexual Functioning</measure>
    <time_frame>Change from baseline to six months</time_frame>
    <description>This will be measured using the Sexual Functioning Scale from the Expanded Prostate Cancer Index Composite - Short Form (EPIC 26-SF), a 26 item shortened version of EPIC, a 61 item questionnaire for assessing urinary, bowel, sexual, and hormonal dysfunction and distress/bother in prostate cancer patients. The scale had six items, each with a Likert-type 4- or 5-item scale, with 1 being the minimum and 4 or 5 being the maximum. These scores were then recoded to a 0 to 100 scale, with higher scores indicating less sexual problems (i.e., better outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Interpersonal Concerns - Medical Interactions</measure>
    <time_frame>Change from baseline to six months</time_frame>
    <description>Satisfaction with communication in medical interactions will be assessed with the medical interactions scale from the Cancer Rehabilitation Evaluation System (CARES): difficulty communicating with the medical team, and problems obtaining information from the medical team. The minimum value is 0 and the maximum value is 4. A higher score means patients had worse medical interactions (i.e., worse outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Interpersonal Concerns - Marital Interactions</measure>
    <time_frame>Change from baseline to six months</time_frame>
    <description>Satisfaction with marital communication will be assessed from the marital problems scale from the Cancer Rehabilitation Evaluation System (CARES). The minimum value is 0 and the maximum value is 4. A higher score means more marital problems (i.e., worse outcome).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">431</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Print materials</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>PROGRESS</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>PROGRESS</intervention_name>
    <description>PROGRESS is a multimedia website designed to help prostate cancer survivors.</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Received a diagnosis of localized disease confined to the prostate, with no regional&#xD;
             lymph node or distant metastasis (stages T1, T1a, T1b, T2, T2a, T2b; T2c [3]);&#xD;
&#xD;
          -  Within one year completion of either radical prostatectomy or radiation&#xD;
             therapy(external beam radiation therapy or brachytherapy);&#xD;
&#xD;
          -  Have access to a personal computer with Internet access (either in home or at a&#xD;
             community center);&#xD;
&#xD;
          -  18 years of age or older;&#xD;
&#xD;
          -  Able to communicate in English&#xD;
&#xD;
          -  Able to give consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to use a computer&#xD;
&#xD;
          -  Unable to communicate in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unable to use a computer&#xD;
&#xD;
          -  unable to communicate in English&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Suzanne Miller, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fox Chase Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rutgers Cancer Insititute of New Jersey</name>
      <address>
        <city>Somerset</city>
        <state>New Jersey</state>
        <zip>08873</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mt Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fox Chase Cancer Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>August 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 25, 2014</study_first_posted>
  <results_first_submitted>February 27, 2020</results_first_submitted>
  <results_first_submitted_qc>October 11, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">October 12, 2021</results_first_posted>
  <last_update_submitted>October 11, 2021</last_update_submitted>
  <last_update_submitted_qc>October 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 8, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/82/NCT02224482/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Control</title>
          <description>Print materials</description>
        </group>
        <group group_id="P2">
          <title>Intervention Group</title>
          <description>PROGRESS&#xD;
PROGRESS: PROGRESS is a multimedia website designed to help prostate cancer survivors.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="214"/>
                <participants group_id="P2" count="217"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="63"/>
                <participants group_id="P2" count="57"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="151"/>
                <participants group_id="P2" count="160"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Control</title>
          <description>Print materials</description>
        </group>
        <group group_id="B2">
          <title>Intervention Group</title>
          <description>PROGRESS&#xD;
PROGRESS: PROGRESS is a multimedia website designed to help prostate cancer survivors.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="214"/>
            <count group_id="B2" value="217"/>
            <count group_id="B3" value="431"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="214"/>
                    <count group_id="B2" value="217"/>
                    <count group_id="B3" value="431"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63.3" spread="7.5"/>
                    <measurement group_id="B2" value="63.8" spread="6.7"/>
                    <measurement group_id="B3" value="63.5" spread="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="214"/>
                    <count group_id="B2" value="217"/>
                    <count group_id="B3" value="431"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="214"/>
                    <measurement group_id="B2" value="217"/>
                    <measurement group_id="B3" value="431"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <population>Different counts due to missing data</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Non-Hispanic White</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="214"/>
                    <count group_id="B2" value="217"/>
                    <count group_id="B3" value="431"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="143"/>
                    <measurement group_id="B2" value="160"/>
                    <measurement group_id="B3" value="303"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="214"/>
                    <count group_id="B2" value="217"/>
                    <count group_id="B3" value="431"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="214"/>
                    <count group_id="B2" value="217"/>
                    <count group_id="B3" value="431"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="214"/>
                    <count group_id="B2" value="217"/>
                    <count group_id="B3" value="431"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="214"/>
                    <count group_id="B2" value="217"/>
                    <count group_id="B3" value="431"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="214"/>
                    <measurement group_id="B2" value="217"/>
                    <measurement group_id="B3" value="431"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>PSA at diagnosis (ng/ml)</title>
          <units>ng/ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="214"/>
                    <count group_id="B2" value="217"/>
                    <count group_id="B3" value="431"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.6" spread="10.7"/>
                    <measurement group_id="B2" value="14.0" spread="49.0"/>
                    <measurement group_id="B3" value="11.4" spread="35.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prostate cancer treatment completed</title>
          <population>Counts different due to missing data</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Surgery Only</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="212"/>
                    <count group_id="B2" value="213"/>
                    <count group_id="B3" value="425"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="131"/>
                    <measurement group_id="B2" value="130"/>
                    <measurement group_id="B3" value="261"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Radiation Only</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="212"/>
                    <count group_id="B2" value="213"/>
                    <count group_id="B3" value="425"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="109"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other (multiple treatments)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="212"/>
                    <count group_id="B2" value="213"/>
                    <count group_id="B3" value="425"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Adaptive Coping</title>
        <description>Adaptive coping was measured with the Cancer Coping Questionnaire. The total score from the Cancer Coping Questionnaire is a mean scale. There were a total of 14 items, each with a Likert-type 4-point scale, with 1 being the minimum value and 4 being the maximum value. A higher score indicated greater coping ability (i.e., better outcome).</description>
        <time_frame>Change in coping from baseline to six months</time_frame>
        <population>Data provided for participants with six month data</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Print materials</description>
          </group>
          <group group_id="O2">
            <title>Intervention Group</title>
            <description>PROGRESS&#xD;
PROGRESS: PROGRESS is a multimedia website designed to help prostate cancer survivors.</description>
          </group>
        </group_list>
        <measure>
          <title>Adaptive Coping</title>
          <description>Adaptive coping was measured with the Cancer Coping Questionnaire. The total score from the Cancer Coping Questionnaire is a mean scale. There were a total of 14 items, each with a Likert-type 4-point scale, with 1 being the minimum value and 4 being the maximum value. A higher score indicated greater coping ability (i.e., better outcome).</description>
          <population>Data provided for participants with six month data</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="103"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.089" spread="0.559"/>
                    <measurement group_id="O2" value="-0.013" spread="0.602"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.9634</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Physical Functioning - Urinary Incontinence</title>
        <description>This will be measured using the Urinary Incontinence Scale from the Expanded Prostate Cancer Index Composite - Short Form (EPIC 26-SF), a 26 item shortened version of EPIC, a 61 item questionnaire for assessing urinary, bowel, sexual, and hormonal dysfunction and distress/bother in prostate cancer patients. The scale had four items, each with a Likert-type 4- or 5-item scale, with 1 being the minimum and 4 or 5 being the maximum. These scores were then recoded to a 0 to 100 scale, with higher scores indicating less urinary incontinence (i.e., better outcome).</description>
        <time_frame>Change from baseline to six months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Print materials</description>
          </group>
          <group group_id="O2">
            <title>Intervention Group</title>
            <description>PROGRESS&#xD;
PROGRESS: PROGRESS is a multimedia website designed to help prostate cancer survivors.</description>
          </group>
        </group_list>
        <measure>
          <title>Physical Functioning - Urinary Incontinence</title>
          <description>This will be measured using the Urinary Incontinence Scale from the Expanded Prostate Cancer Index Composite - Short Form (EPIC 26-SF), a 26 item shortened version of EPIC, a 61 item questionnaire for assessing urinary, bowel, sexual, and hormonal dysfunction and distress/bother in prostate cancer patients. The scale had four items, each with a Likert-type 4- or 5-item scale, with 1 being the minimum and 4 or 5 being the maximum. These scores were then recoded to a 0 to 100 scale, with higher scores indicating less urinary incontinence (i.e., better outcome).</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="101"/>
                <count group_id="O2" value="96"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.240" spread="19.671"/>
                    <measurement group_id="O2" value="10.750" spread="21.933"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.5214</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Physical Functioning - Urinary Irritation</title>
        <description>This will be measured using the Urinary Irritation Scale from the Expanded Prostate Cancer Index Composite - Short Form (EPIC 26-SF), a 26 item shortened version of EPIC, a 61 item questionnaire for assessing urinary, bowel, sexual, and hormonal dysfunction and distress/bother in prostate cancer patients. The scale had four items, each with a Likert-type 4- or 5-item scale, with 1 being the minimum and 4 or 5 being the maximum. These scores were then recoded to a 0 to 100 scale, with higher scores indicating less urinary irritation (i.e., better outcome).</description>
        <time_frame>Change from baseline to six months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Print materials</description>
          </group>
          <group group_id="O2">
            <title>Intervention Group</title>
            <description>PROGRESS&#xD;
PROGRESS: PROGRESS is a multimedia website designed to help prostate cancer survivors.</description>
          </group>
        </group_list>
        <measure>
          <title>Physical Functioning - Urinary Irritation</title>
          <description>This will be measured using the Urinary Irritation Scale from the Expanded Prostate Cancer Index Composite - Short Form (EPIC 26-SF), a 26 item shortened version of EPIC, a 61 item questionnaire for assessing urinary, bowel, sexual, and hormonal dysfunction and distress/bother in prostate cancer patients. The scale had four items, each with a Likert-type 4- or 5-item scale, with 1 being the minimum and 4 or 5 being the maximum. These scores were then recoded to a 0 to 100 scale, with higher scores indicating less urinary irritation (i.e., better outcome).</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.063" spread="17.200"/>
                    <measurement group_id="O2" value="7.979" spread="16.660"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.4875</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Physical Functioning - Bowel</title>
        <description>This will be measured using the Bowel Scale from the Expanded Prostate Cancer Index Composite - Short Form (EPIC 26-SF), a 26 item shortened version of EPIC, a 61 item questionnaire for assessing urinary, bowel, sexual, and hormonal dysfunction and distress/bother in prostate cancer patients. The scale had six items, each with a Likert-type 4- or 5-item scale, with 1 being the minimum and 4 or 5 being the maximum. These scores were then recoded to a 0 to 100 scale, with higher scores indicating less bowel problems (i.e., better outcome).</description>
        <time_frame>Change from baseline to six months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Print materials</description>
          </group>
          <group group_id="O2">
            <title>Intervention Group</title>
            <description>PROGRESS&#xD;
PROGRESS: PROGRESS is a multimedia website designed to help prostate cancer survivors.</description>
          </group>
        </group_list>
        <measure>
          <title>Physical Functioning - Bowel</title>
          <description>This will be measured using the Bowel Scale from the Expanded Prostate Cancer Index Composite - Short Form (EPIC 26-SF), a 26 item shortened version of EPIC, a 61 item questionnaire for assessing urinary, bowel, sexual, and hormonal dysfunction and distress/bother in prostate cancer patients. The scale had six items, each with a Likert-type 4- or 5-item scale, with 1 being the minimum and 4 or 5 being the maximum. These scores were then recoded to a 0 to 100 scale, with higher scores indicating less bowel problems (i.e., better outcome).</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.479" spread="13.330"/>
                    <measurement group_id="O2" value="3.119" spread="14.847"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.7938</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Physical Functioning - Sexual Functioning</title>
        <description>This will be measured using the Sexual Functioning Scale from the Expanded Prostate Cancer Index Composite - Short Form (EPIC 26-SF), a 26 item shortened version of EPIC, a 61 item questionnaire for assessing urinary, bowel, sexual, and hormonal dysfunction and distress/bother in prostate cancer patients. The scale had six items, each with a Likert-type 4- or 5-item scale, with 1 being the minimum and 4 or 5 being the maximum. These scores were then recoded to a 0 to 100 scale, with higher scores indicating less sexual problems (i.e., better outcome).</description>
        <time_frame>Change from baseline to six months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Print materials</description>
          </group>
          <group group_id="O2">
            <title>Intervention Group</title>
            <description>PROGRESS&#xD;
PROGRESS: PROGRESS is a multimedia website designed to help prostate cancer survivors.</description>
          </group>
        </group_list>
        <measure>
          <title>Physical Functioning - Sexual Functioning</title>
          <description>This will be measured using the Sexual Functioning Scale from the Expanded Prostate Cancer Index Composite - Short Form (EPIC 26-SF), a 26 item shortened version of EPIC, a 61 item questionnaire for assessing urinary, bowel, sexual, and hormonal dysfunction and distress/bother in prostate cancer patients. The scale had six items, each with a Likert-type 4- or 5-item scale, with 1 being the minimum and 4 or 5 being the maximum. These scores were then recoded to a 0 to 100 scale, with higher scores indicating less sexual problems (i.e., better outcome).</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="96"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.793" spread="19.829"/>
                    <measurement group_id="O2" value="3.046" spread="21.402"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.6765</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Interpersonal Concerns - Medical Interactions</title>
        <description>Satisfaction with communication in medical interactions will be assessed with the medical interactions scale from the Cancer Rehabilitation Evaluation System (CARES): difficulty communicating with the medical team, and problems obtaining information from the medical team. The minimum value is 0 and the maximum value is 4. A higher score means patients had worse medical interactions (i.e., worse outcome).</description>
        <time_frame>Change from baseline to six months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Print materials</description>
          </group>
          <group group_id="O2">
            <title>Intervention Group</title>
            <description>PROGRESS&#xD;
PROGRESS: PROGRESS is a multimedia website designed to help prostate cancer survivors.</description>
          </group>
        </group_list>
        <measure>
          <title>Interpersonal Concerns - Medical Interactions</title>
          <description>Satisfaction with communication in medical interactions will be assessed with the medical interactions scale from the Cancer Rehabilitation Evaluation System (CARES): difficulty communicating with the medical team, and problems obtaining information from the medical team. The minimum value is 0 and the maximum value is 4. A higher score means patients had worse medical interactions (i.e., worse outcome).</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="103"/>
                <count group_id="O2" value="96"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.311" spread="2.783"/>
                    <measurement group_id="O2" value="-0.531" spread="2.554"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.7061</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Interpersonal Concerns - Marital Interactions</title>
        <description>Satisfaction with marital communication will be assessed from the marital problems scale from the Cancer Rehabilitation Evaluation System (CARES). The minimum value is 0 and the maximum value is 4. A higher score means more marital problems (i.e., worse outcome).</description>
        <time_frame>Change from baseline to six months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Print materials</description>
          </group>
          <group group_id="O2">
            <title>Intervention Group</title>
            <description>PROGRESS&#xD;
PROGRESS: PROGRESS is a multimedia website designed to help prostate cancer survivors.</description>
          </group>
        </group_list>
        <measure>
          <title>Interpersonal Concerns - Marital Interactions</title>
          <description>Satisfaction with marital communication will be assessed from the marital problems scale from the Cancer Rehabilitation Evaluation System (CARES). The minimum value is 0 and the maximum value is 4. A higher score means more marital problems (i.e., worse outcome).</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="95"/>
                <count group_id="O2" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.042" spread="3.956"/>
                    <measurement group_id="O2" value="0.182" spread="3.358"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.7593</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data was collected for each participant over a 6 month period through 6-month follow-up.</time_frame>
      <desc>No adverse events anticipated in low-risk behavioral trial.</desc>
      <group_list>
        <group group_id="E1">
          <title>Control</title>
          <description>Print materials</description>
        </group>
        <group group_id="E2">
          <title>Intervention Group</title>
          <description>PROGRESS&#xD;
PROGRESS: PROGRESS is a multimedia website designed to help prostate cancer survivors.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Suzanne Miller</name_or_title>
      <organization>Fox Chase Cancer Center</organization>
      <phone>215-728-4069</phone>
      <email>Suzanne.Miller@fccc.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02224482
org study id: 1R01CA158019
secondary id: R01CA158019
nct id: NCT02224482
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to test how well an online program designed to help prostate
      cancer survivors cope with changes caused by their cancer or treatment works compared to
      standard print educational materials from the National Cancer Institute (NCI).
This study involves the development and evaluation of a comprehensive and innovative
      multimedia program designed to facilitate the post-treatment transition into survivorship.
      The design of the intervention, the PRostate Cancer Online Guide and Resources for Electronic
      Survivorship Service (PROGRESS), is theoretically based on the team's Cognitive-Social Health
      Information Processing Model.

      PROGRESS focuses on promoting adaptive coping within four key post-treatment domains: 1)
      Physical Dysfunction (e.g., physical symptoms); 2) Emotional Well- Being (e.g., fear of
      recurrence); 3) Interpersonal Concerns (e.g., sexual intimacy issues); and 4) Practical
      Barriers (e.g., medical follow-up challenges). Content for these domains are organized in a
      virtual resource center and will consist of: 1) provision of related information through
      text, graphics, voice overs, and animation; 2) videos of health care experts answering
      frequently asked questions; 3) videos of prostate cancer survivors describing their
      experiences and modeling competencies and coping strategies; and 4) skills training to
      improve communication between prostate cancer survivors and family and healthcare providers.
      Program content has been developed through literature and evidence-based content review,
      expert input, and input from multi-ethnic survivor focus groups. To ensure adequate and
      appropriate program content and optimal functionality, an iterative process of review,
      revision, and user and usability testing has been employed.

      Intervention efficacy will be evaluated through a two-arm, prospective randomized controlled
      trial. A total of 600 patients (200 from Fox Chase Cancer Center, 200 from the Cancer
      Institute of New Jersey, and 200 from Icahn School of Medicine at Mount Sinai) will complete
      the study. Data will be collected at baseline, and at 1-, 3- and 6- months follow-up.

      The primary outcome variable will be use of adaptive coping, and secondary outcome variables
      will include use of maladaptive coping, disease-specific quality of life, vitality/energy,
      physical quality of life, cancer-related intrusive thoughts, emotional quality of life, fear
      of recurrence, bother from physical dysfunctions, satisfaction with communication in medical
      interactions, satisfaction with cancer-related with family/friends, marital problems, and
      practical concerns . A theory-based test of mediators of intervention effects (i.e.,
      self-efficacy for the survivorship phase, confidence in ability to manage symptoms related to
      prostate cancer, perceived information utility), and moderators (i.e., demographics, comorbid
      conditions, monitoring style, affect) will also be performed.

      The proposed research will be the first Randomized Controlled Trial to evaluate a
      comprehensive and highly disseminable and self-sustaining intervention for facilitating
      post-treatment adaptation among early-stage Pca survivors. In addition, use of and usability,
      accessibility, and satisfaction with PROGRESS will be assessed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
measure: Adaptive Coping
time frame: Change in coping from baseline to six months
description: Adaptive coping was measured with the Cancer Coping Questionnaire. The total score from the Cancer Coping Questionnaire is a mean scale. There were a total of 14 items, each with a Likert-type 4-point scale, with 1 being the minimum value and 4 being the maximum value. A higher score indicated greater coping ability (i.e., better outcome).
measure: Physical Functioning - Urinary Incontinence
time frame: Change from baseline to six months
description: This will be measured using the Urinary Incontinence Scale from the Expanded Prostate Cancer Index Composite - Short Form (EPIC 26-SF), a 26 item shortened version of EPIC, a 61 item questionnaire for assessing urinary, bowel, sexual, and hormonal dysfunction and distress/bother in prostate cancer patients. The scale had four items, each with a Likert-type 4- or 5-item scale, with 1 being the minimum and 4 or 5 being the maximum. These scores were then recoded to a 0 to 100 scale, with higher scores indicating less urinary incontinence (i.e., better outcome).
measure: Physical Functioning - Urinary Irritation
time frame: Change from baseline to six months
description: This will be measured using the Urinary Irritation Scale from the Expanded Prostate Cancer Index Composite - Short Form (EPIC 26-SF), a 26 item shortened version of EPIC, a 61 item questionnaire for assessing urinary, bowel, sexual, and hormonal dysfunction and distress/bother in prostate cancer patients. The scale had four items, each with a Likert-type 4- or 5-item scale, with 1 being the minimum and 4 or 5 being the maximum. These scores were then recoded to a 0 to 100 scale, with higher scores indicating less urinary irritation (i.e., better outcome).
measure: Physical Functioning - Bowel
time frame: Change from baseline to six months
description: This will be measured using the Bowel Scale from the Expanded Prostate Cancer Index Composite - Short Form (EPIC 26-SF), a 26 item shortened version of EPIC, a 61 item questionnaire for assessing urinary, bowel, sexual, and hormonal dysfunction and distress/bother in prostate cancer patients. The scale had six items, each with a Likert-type 4- or 5-item scale, with 1 being the minimum and 4 or 5 being the maximum. These scores were then recoded to a 0 to 100 scale, with higher scores indicating less bowel problems (i.e., better outcome).
measure: Physical Functioning - Sexual Functioning
time frame: Change from baseline to six months
description: This will be measured using the Sexual Functioning Scale from the Expanded Prostate Cancer Index Composite - Short Form (EPIC 26-SF), a 26 item shortened version of EPIC, a 61 item questionnaire for assessing urinary, bowel, sexual, and hormonal dysfunction and distress/bother in prostate cancer patients. The scale had six items, each with a Likert-type 4- or 5-item scale, with 1 being the minimum and 4 or 5 being the maximum. These scores were then recoded to a 0 to 100 scale, with higher scores indicating less sexual problems (i.e., better outcome).
measure: Interpersonal Concerns - Medical Interactions
time frame: Change from baseline to six months
description: Satisfaction with communication in medical interactions will be assessed with the medical interactions scale from the Cancer Rehabilitation Evaluation System (CARES): difficulty communicating with the medical team, and problems obtaining information from the medical team. The minimum value is 0 and the maximum value is 4. A higher score means patients had worse medical interactions (i.e., worse outcome).
measure: Interpersonal Concerns - Marital Interactions
time frame: Change from baseline to six months
description: Satisfaction with marital communication will be assessed from the marital problems scale from the Cancer Rehabilitation Evaluation System (CARES). The minimum value is 0 and the maximum value is 4. A higher score means more marital problems (i.e., worse outcome).
arm group label: Control
arm group type: No Intervention
description: Print materials
arm group label: Intervention Group
arm group type: Active Comparator
description: PROGRESS
intervention type: Behavioral
intervention name: PROGRESS
description: PROGRESS is a multimedia website designed to help prostate cancer survivors.
arm group label: Intervention Group
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Suzanne Miller, PhD
role: Principal Investigator
affiliation: Fox Chase Cancer Center
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
provided document: 
participant flow: 
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outcome list: 
reported events: 
certain agreements: 
point of contact: 