<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/NCT01716702</url>
  </required_header>
  <id_info>
    <org_study_id>CDHA-RS/2013-076</org_study_id>
    <nct_id>NCT01716702</nct_id>
  </id_info>
  <brief_title>A Feasibility Study of an Online Intervention for Sexual Rehabilitation in Prostate Cancer</brief_title>
  <official_title>A Feasibility Study of an Online Intervention for Sexual Rehabilitation in Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nova Scotia Health Authority</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canada: Beatrice Hunter Cancer Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Nova Scotia Health Authority</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Prostate cancer (PCa) is the most common cancer for men. When treated early&#xD;
      enough it is typically curable. However, common treatments, such as radical prostatectomy and&#xD;
      radiation therapy, often result in significant negative outcomes with regard to sexual,&#xD;
      psychological and social function. Both men and partners have identified the need for more&#xD;
      information and support to address sexual health concerns after treatment. However, very few&#xD;
      sexual rehabilitation interventions have been developed and rigorously assessed.&#xD;
&#xD;
      Purpose: The investigators propose to develop and pilot test a new program to meet the sexual&#xD;
      health needs of men with PCa and their partners using an online, professionally facilitated&#xD;
      education/support program. The goals of the program are to improve sexual function, intimacy&#xD;
      and mood for men and their partners after treatment for localized PCa. The program will be&#xD;
      offered through Cancer Chat Canada, an existing and well-tested Canadian platform for&#xD;
      professionally facilitated support group programs.&#xD;
&#xD;
      What Participants Can Expect: A total of 24 men and their female partners (48 individuals)&#xD;
      will be recruited and assigned to one of two groups. The first group will participate in the&#xD;
      program immediately; the second group will be offered the program after a 5-month delay. The&#xD;
      decision about which group will start immediately and which later will be made randomly (by&#xD;
      chance). Both groups of men and partners will be asked to complete questionnaires three times&#xD;
      and, at the end of the program, to provide the researchers feedback about how satisfied they&#xD;
      were with the program, the changes they made, things they learned as a result of the program,&#xD;
      and suggestions for improving the program. Participants must have access to a computer, an&#xD;
      Internet connection and be willing to attend online, chat room meetings each week for 1.5&#xD;
      hours for 6 weeks.&#xD;
&#xD;
      Implications: Sexual rehabilitation is a high need for men affected by PCa, but is difficult&#xD;
      to access. The investigators hope to improve access to sexual health care through this study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">December 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>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Sexual Function from Baseline to 13 weeks</measure>
    <time_frame>Pre-Intervention (Week 1); Post-Intervention (Week 7); 3 Months Post-Intervention (Week 13)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Personal Assessment of Intimacy and Relationships from baseline to 13 weeks</measure>
    <time_frame>Pre-Intervention (Week 1); Post-Intervention (Week 7); 3 Months Post-Intervention (Week 13)</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Profile of Mood States Short Form from baseline to 13 weeks</measure>
    <time_frame>Pre-Intervention (Week 1); Post-Intervention (Week 7); 3 Months Post-Intervention (Week 13)</time_frame>
    <description>This tool assesses psychological distress across 6 domains: fatigue-inertia, vigor-activity, tension-anxiety, depression-dejection, anger-hostility, and confusion-bewilderment.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">48</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Couples Prostate Cancer Support Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participants in the support group will receive 6 weekly online intervention sessions with a professional facilitator. In addition participants will be asked to complete relationship-enhancement exercises and readings in between sessions.&#xD;
Participants will be asked to complete questionnaires at three time points: 1)pre-intervention (baseline) 2) post-intervention (7 weeks), and 3) post intervention (13 weeks).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait-List Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will be asked to complete questionnaires at three time points: 1)week 1 2) week 7, and 3) week 13.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Couples Prostate Cancer Support Group</intervention_name>
    <description>The participants in the experimental group will receive 6 weekly online intervention sessions with a professional facilitator. In addition participants will be asked to complete relationship-enhancement exercises and readings in between sessions.&#xD;
In the experimental group, participants will be asked to complete questionnaires at three time points: 1)pre-intervention (baseline) 2) post-intervention (7 weeks), and 3) post intervention (13 weeks).&#xD;
In the waitlist group, participants will not participate in the support group. Participants will be asked to complete questionnaires at three time points: 1)pre-intervention (baseline) 2) post-intervention (7 weeks), and 3) post intervention (13 weeks).</description>
    <arm_group_label>Couples Prostate Cancer Support Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men who have been treated for localized prostate cancer&#xD;
&#xD;
          -  AND men must be 6-36 months post-prostatectomy or radiation (as primary treatment) of&#xD;
             prostate cancer&#xD;
&#xD;
          -  Must have a heterosexual, co-cohabiting partner who is willing to participate&#xD;
&#xD;
          -  Must speak and read English&#xD;
&#xD;
          -  Must be able to use a computer and have internet access&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Homosexual couples will not be included in this study&#xD;
&#xD;
          -  Major self-reported psychiatric illness&#xD;
&#xD;
          -  Couples who screen below 30 on the DAS (Dyadic Adjustment Scale)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Deborah L McLeod, R.N., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Capital District Health Authority &amp; Dalhousie University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Richard J Wassersug, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of British Columbia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Karen Fergus, Ph.D., C. Psych.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sunnybrook Odette Cancer Centre &amp; York University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>John Robinson, Ph.D., C. Psych.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tom Baker Cancer Centre &amp; University of Calgary</affiliation>
  </overall_official>
  <overall_official>
    <last_name>John Oliffe, R.N, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of British Columbia</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Deborah L McLeod, R.N., Ph.D.</last_name>
    <phone>902-473-2964</phone>
    <email>DeborahL.McLeod@cdha.nshealth.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>Capital District</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Deborah L McLeod</last_name>
      <phone>902-473-2964</phone>
      <email>DeborahL.McLeod@cdha.nshealth.ca</email>
    </contact>
    <investigator>
      <last_name>Deborah L McLeod, R.N., Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2014</verification_date>
  <study_first_submitted>October 16, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>March 13, 2014</last_update_submitted>
  <last_update_submitted_qc>March 13, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 14, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prostate Cancer</keyword>
  <keyword>Psychosocial Intervention</keyword>
  <keyword>Sexual Rehabilitation</keyword>
  <keyword>Online Intervention</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/NCT01716702
org study id: CDHA-RS/2013-076
nct id: NCT01716702
lead sponsor: 
collaborator: 
has dmc: Yes
Background: Prostate cancer (PCa) is the most common cancer for men. When treated early
      enough it is typically curable. However, common treatments, such as radical prostatectomy and
      radiation therapy, often result in significant negative outcomes with regard to sexual,
      psychological and social function. Both men and partners have identified the need for more
      information and support to address sexual health concerns after treatment. However, very few
      sexual rehabilitation interventions have been developed and rigorously assessed.

      Purpose: The investigators propose to develop and pilot test a new program to meet the sexual
      health needs of men with PCa and their partners using an online, professionally facilitated
      education/support program. The goals of the program are to improve sexual function, intimacy
      and mood for men and their partners after treatment for localized PCa. The program will be
      offered through Cancer Chat Canada, an existing and well-tested Canadian platform for
      professionally facilitated support group programs.

      What Participants Can Expect: A total of 24 men and their female partners (48 individuals)
      will be recruited and assigned to one of two groups. The first group will participate in the
      program immediately; the second group will be offered the program after a 5-month delay. The
      decision about which group will start immediately and which later will be made randomly (by
      chance). Both groups of men and partners will be asked to complete questionnaires three times
      and, at the end of the program, to provide the researchers feedback about how satisfied they
      were with the program, the changes they made, things they learned as a result of the program,
      and suggestions for improving the program. Participants must have access to a computer, an
      Internet connection and be willing to attend online, chat room meetings each week for 1.5
      hours for 6 weeks.

      Implications: Sexual rehabilitation is a high need for men affected by PCa, but is difficult
      to access. The investigators hope to improve access to sexual health care through this study.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in Sexual Function from Baseline to 13 weeks
time frame: Pre-Intervention (Week 1); Post-Intervention (Week 7); 3 Months Post-Intervention (Week 13)
measure: Change in Personal Assessment of Intimacy and Relationships from baseline to 13 weeks
time frame: Pre-Intervention (Week 1); Post-Intervention (Week 7); 3 Months Post-Intervention (Week 13)
measure: Change in Profile of Mood States Short Form from baseline to 13 weeks
time frame: Pre-Intervention (Week 1); Post-Intervention (Week 7); 3 Months Post-Intervention (Week 13)
description: This tool assesses psychological distress across 6 domains: fatigue-inertia, vigor-activity, tension-anxiety, depression-dejection, anger-hostility, and confusion-bewilderment.
arm group label: Couples Prostate Cancer Support Group
arm group type: Experimental
description: The participants in the support group will receive 6 weekly online intervention sessions with a professional facilitator. In addition participants will be asked to complete relationship-enhancement exercises and readings in between sessions.
Participants will be asked to complete questionnaires at three time points: 1)pre-intervention (baseline) 2) post-intervention (7 weeks), and 3) post intervention (13 weeks).
arm group label: Wait-List Control
arm group type: No Intervention
description: Participants will be asked to complete questionnaires at three time points: 1)week 1 2) week 7, and 3) week 13.
intervention type: Behavioral
intervention name: Couples Prostate Cancer Support Group
description: The participants in the experimental group will receive 6 weekly online intervention sessions with a professional facilitator. In addition participants will be asked to complete relationship-enhancement exercises and readings in between sessions.
In the experimental group, participants will be asked to complete questionnaires at three time points: 1)pre-intervention (baseline) 2) post-intervention (7 weeks), and 3) post intervention (13 weeks).
In the waitlist group, participants will not participate in the support group. Participants will be asked to complete questionnaires at three time points: 1)pre-intervention (baseline) 2) post-intervention (7 weeks), and 3) post intervention (13 weeks).
arm group label: Couples Prostate Cancer Support Group
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Deborah L McLeod, R.N., Ph.D.
role: Principal Investigator
affiliation: Capital District Health Authority & Dalhousie University
last name: Richard J Wassersug, Ph.D.
role: Principal Investigator
affiliation: University of British Columbia
last name: Karen Fergus, Ph.D., C. Psych.
role: Principal Investigator
affiliation: Sunnybrook Odette Cancer Centre & York University
last name: John Robinson, Ph.D., C. Psych.
role: Principal Investigator
affiliation: Tom Baker Cancer Centre & University of Calgary
last name: John Oliffe, R.N, Ph.D.
role: Principal Investigator
affiliation: University of British Columbia
last name: Deborah L McLeod, R.N., Ph.D.
phone: 902-473-2964
email: DeborahL.McLeod@cdha.nshealth.ca
facility: 
status: Recruiting
contact: 
investigator: 
country: Canada
responsible party type: Sponsor
mesh term: Prostatic Neoplasms