<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/NCT04471363</url>
  </required_header>
  <id_info>
    <org_study_id>17-1649.cc</org_study_id>
    <nct_id>NCT04471363</nct_id>
  </id_info>
  <brief_title>Cancer Survivors and Their Romantic Partners' Preferences for a Couples-based Physical Activity</brief_title>
  <official_title>Cancer Survivors and Their Romantic Partners' Preferences for a Couples-based Physical Activity Intervention: A Needs Assessment Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this research is to explore cancer survivors' and their romantic partners'&#xD;
      interest in a couples-based physical activity intervention and whether cancer-specific&#xD;
      exercise education influences exercise beliefs and intentions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will assess multiple predictors of couples-based physical activity interest among&#xD;
      both survivors and partners including gender, age, current exercise, relationship&#xD;
      satisfaction and partner support for exercise. Additionally, this study will include an&#xD;
      experimental manipulation in which half of the sample will be randomized to receive&#xD;
      cancer-specific exercise education.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 14, 2018</start_date>
  <completion_date type="Anticipated">February 8, 2024</completion_date>
  <primary_completion_date type="Actual">February 8, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Questionnaire to determine predictors</measure>
    <time_frame>45 minutes</time_frame>
    <description>All participants will be asked to indicate their exercise knowledge, self-efficacy, beliefs and intentions. Participation in this study will last approximately 45 minutes, and all data will be collected using an on-line Redcap survey. Predictors to be examined are gender, age, current exercise, relationship satisfaction and partner support for exercise.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">448</enrollment>
  <condition>Cancer Diagnosis</condition>
  <condition>Couples</condition>
  <arm_group>
    <arm_group_label>Cancer Specific Exercise Education</arm_group_label>
    <description>This subsample of participants will watch an audio-recorded PowerPoint presentation created by the study team on the benefits of exercise for survivors, caregivers and romantic couples.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>All participants will be asked to indicate their exercise knowledge, self-efficacy, beliefs and intentions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cancer-Specific Exercise education</intervention_name>
    <description>An audio-recorded PowerPoint presentation created by the study team on the benefits of exercise for survivors, caregivers and romantic couples.</description>
    <arm_group_label>Cancer Specific Exercise Education</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        We are interested in hearing from cancer survivors and romantic partners from diverse&#xD;
        backgrounds. This study is open to both active and inactive individuals. Cancer survivors&#xD;
        can have had any type of cancer, cancer treatment, or recurrence(s). Further, we are not&#xD;
        limiting participation based on time since diagnosis. Romantic partners do not need to be&#xD;
        married, co-habituating, or in a relationship for a specific time-period in order to be&#xD;
        eligible. Additionally, this study will not exclude couples in which both individuals are&#xD;
        cancer survivors. Lastly, while we prefer both partners within a couple participate, we&#xD;
        will not exclude individual participation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        In order to be eligible, individuals must answer &quot;Yes&quot; to all of the following statements:&#xD;
&#xD;
          -  I am a cancer survivor OR I am the romantic partner of a cancer survivor&#xD;
&#xD;
          -  I am not currently undergoing chemotherapy, radiation or surgery nor do I have plans&#xD;
             to undergo chemotherapy, radiation or a cancer-related surgery in the next 6 months&#xD;
&#xD;
          -  I am in a committed, romantic relationship&#xD;
&#xD;
          -  I have access to a computer or tablet with internet&#xD;
&#xD;
          -  I have an email address that I am willing to share with the study team&#xD;
&#xD;
          -  I am at least 18 years of age and less than 90 years of age&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Colorado Hospital</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>March 27, 2023</last_update_submitted>
  <last_update_submitted_qc>March 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04471363
org study id: 17-1649.cc
nct id: NCT04471363
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The goal of this research is to explore cancer survivors' and their romantic partners'
      interest in a couples-based physical activity intervention and whether cancer-specific
      exercise education influences exercise beliefs and intentions.
This study will assess multiple predictors of couples-based physical activity interest among
      both survivors and partners including gender, age, current exercise, relationship
      satisfaction and partner support for exercise. Additionally, this study will include an
      experimental manipulation in which half of the sample will be randomized to receive
      cancer-specific exercise education.
observational model: Case-Only
time perspective: Prospective
measure: Questionnaire to determine predictors
time frame: 45 minutes
description: All participants will be asked to indicate their exercise knowledge, self-efficacy, beliefs and intentions. Participation in this study will last approximately 45 minutes, and all data will be collected using an on-line Redcap survey. Predictors to be examined are gender, age, current exercise, relationship satisfaction and partner support for exercise.
arm group label: Cancer Specific Exercise Education
description: This subsample of participants will watch an audio-recorded PowerPoint presentation created by the study team on the benefits of exercise for survivors, caregivers and romantic couples.
arm group label: Control
description: All participants will be asked to indicate their exercise knowledge, self-efficacy, beliefs and intentions.
intervention type: Behavioral
intervention name: Cancer-Specific Exercise education
description: An audio-recorded PowerPoint presentation created by the study team on the benefits of exercise for survivors, caregivers and romantic couples.
arm group label: Cancer Specific Exercise Education
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No