<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/NCT03266718</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00060926</org_study_id>
    <nct_id>NCT03266718</nct_id>
  </id_info>
  <brief_title>Move 2 Health: A Couple-Based Physical Activity Intervention for Cancer Survivors</brief_title>
  <official_title>A Couple-Based Physical Activity Intervention for Cancer Survivors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>No</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>
      This pilot study will develop and test a couple-based physical activity intervention among&#xD;
      cancer survivors and their partners.&#xD;
&#xD;
      Aim 1: To determine the feasibility and acceptability of a couple-based physical activity&#xD;
      intervention for cancer survivors. Feasibility will be quantified using rates of study&#xD;
      eligibility, overall accrual, attrition, and adherence to the study protocol. Acceptability&#xD;
      will be assessed via couples' ratings on a standardized measure of treatment effectiveness/&#xD;
      satisfaction, supplemented open-ended questions&#xD;
&#xD;
      Aim 2: To provide preliminary data on the effects of a couple-based physical activity&#xD;
      intervention relative to a wait list control group on survivor outcomes (i.e., level of&#xD;
      physical activity, quality of life, self-efficacy for achieving and maintaining physical&#xD;
      activity goals, perceived partner support for physical activity, and quality of the&#xD;
      survivor-partner relationship). The investigators hypothesize that the intervention will&#xD;
      produce benefits in each of these domains.&#xD;
&#xD;
      Aim 3: To provide preliminary data on the effects of a couple-based physical activity&#xD;
      intervention relative to a wait list control group on partner outcomes (i.e., partner's level&#xD;
      of physical activity, self-efficacy for helping the survivor achieve and maintain physical&#xD;
      activity goals, and quality of the survivor-partner relationship). The investigators&#xD;
      hypothesize that the couple-based intervention will produce benefits in each of these&#xD;
      domains.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background and Significance:&#xD;
&#xD;
      Physical activity (PA) is an essential part of cancer survivors' treatment plan as it helps&#xD;
      prevent recurrence and improves cardiovascular fitness and downstream cardiovascular risk,&#xD;
      the cause for most deaths in cancer survivors. Additional benefits of increasing PA include&#xD;
      improvements in body composition, physical function, psychological outcomes, and quality of&#xD;
      life. However, most survivors are not sufficiently active and would benefit from an&#xD;
      intervention to promote PA. Prior PA interventions for cancer survivors have had mixed&#xD;
      success. A recent systematic review identified 14 RCTs testing exercise interventions among&#xD;
      sedentary cancer survivors and concluded that there was insufficient evidence that existing&#xD;
      interventions are successful in achieving recommended levels of PA. In particular, there has&#xD;
      been a lack of attention to psychosocial aspects of changing behavior, and to strategies that&#xD;
      promote independent exercise behavior that can be maintained over time. Thus, it is clear&#xD;
      that novel approaches to PA interventions are needed.&#xD;
&#xD;
      Design:&#xD;
&#xD;
      This is a two-arm randomized controlled trial to evaluate a couple-based physical activity&#xD;
      (PA) intervention that systematically trains partners in skills to support the survivor in PA&#xD;
      initiation and maintenance strategies.&#xD;
&#xD;
      Couples randomized to Arm 1 (the Couples-Based Physical Activity Intervention) will receive&#xD;
      four 60-minute intervention sessions via videoconference with Duke staff. Study staff will&#xD;
      provide couples with instructions for use of the iPad computer (if provided by the study) and&#xD;
      videoconference software which will be used to deliver the intervention sessions. Couples&#xD;
      will also be provided with contact information for technical support. The first 3 sessions&#xD;
      will be conducted weekly, with a booster session occurring approximately one month later. The&#xD;
      intervention will include components to (a) encourage couples' favorable outcome expectations&#xD;
      about the benefits of working together to initiate and maintain increases in PA, (b) build&#xD;
      their confidence that they can work together to accomplish their goals, and (c) help them&#xD;
      identify and use communal strategies, such as couple communication and joint decision making&#xD;
      about goals and plans for increasing physical activity, and working through barriers to&#xD;
      making these changes. Finally, the intervention will incorporate important behavior change&#xD;
      techniques that have been found to help people change their exercise behavior, such as goal&#xD;
      setting, self-monitoring of behavior, and prompts for practice, adapting them to a communal&#xD;
      coping approach. Treatment sessions will be audio recorded for QA purposes.&#xD;
&#xD;
      Those randomized to Arm 2 (waitlist control) will have the option to receive the intervention&#xD;
      after they complete the follow-up survey. This version of the intervention will not include&#xD;
      the booster session, so will last approximately 1 month in total. If they choose to receive&#xD;
      the intervention, they will be provided with a tablet computer if they do not have one.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2015</start_date>
  <completion_date type="Actual">December 11, 2016</completion_date>
  <primary_completion_date type="Actual">September 26, 2016</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>Feasibility of a couple-based physical activity intervention for cancer survivors as measured by a composite score of total number of couples screened and rates for non-eligibility.</measure>
    <time_frame>2 months after baseline survey</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility of a couple-based physical activity intervention for cancer survivors as measured by a composite score of total number of couples screened and rates of refusal.</measure>
    <time_frame>2 months after baseline survey</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability of a couple-based physical activity intervention for cancer survivors as measured by a composite score of total number of couples screened and rates for non-eligibility.</measure>
    <time_frame>2 months after baseline survey</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability of a couple-based physical activity intervention for cancer survivors as measured by a composite score of total number of couples screened and rates of refusal.</measure>
    <time_frame>2 months after baseline survey</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Efficacy as measured by steps taken</measure>
    <time_frame>2 months after baseline survey</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life as measured by surveys</measure>
    <time_frame>2 months after baseline survey</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self -efficacy for achieving and maintaining physical activity goals as measured by surveys</measure>
    <time_frame>2 months after baseline survey</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived partner support for physical activity as measured by surveys</measure>
    <time_frame>2 months after baseline survey</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of the survivor-partner relationship as measured by surveys</measure>
    <time_frame>2 months after baseline survey</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Physical Activity</condition>
  <condition>Cancer Survivor</condition>
  <arm_group>
    <arm_group_label>Physical Activity Intervention</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Couples will receive four 60-minute intervention sessions via videoconference with Duke staff. Study staff will provide couples with instructions for use of the iPad computer and videoconference software which will be used to deliver the intervention sessions.The first 3 sessions will be conducted weekly, with a booster session occurring approximately one month later.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waitlist control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Couples will have the option to receive the intervention after they complete the follow-up survey. This version of the intervention will not include the booster session, so will last approximately 1 month in total. If they choose to receive the intervention, they will be provided with a tablet computer if they do not have one.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Physical Activity Intervention</intervention_name>
    <description>To develop and test a couple-based physical activity intervention among cancer survivors and their partners</description>
    <arm_group_label>Physical Activity Intervention</arm_group_label>
    <arm_group_label>Waitlist control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Survivor participants are those who have been diagnosed with breast or prostate&#xD;
             cancer, who are married or in a committed relationship and live with their partner,&#xD;
             and who are sedentary (e.g., not undertaking dedicated physical activity on 3 or more&#xD;
             days per week). Both survivors and their partners must be at least 18 years of age, be&#xD;
             fluent in English, and be eligible and willing to participate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  We will exclude patients and/or partners with known metastatic disease, who are&#xD;
             hearing impaired, who are deemed too sick to participate, who have a medical condition&#xD;
             that prohibits them from prolonged walking, who are participating in another research&#xD;
             study that promotes increased exercise, or who have evidence of unstable cognitive or&#xD;
             mental health problems who cannot properly provide consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laura Porter, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>August 28, 2017</last_update_submitted>
  <last_update_submitted_qc>August 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cancer survivor</keyword>
  <keyword>breast cancer</keyword>
  <keyword>prostate cancer</keyword>
  <keyword>couples</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>We will not share IPD unless requested by Duke Researchers only.</ipd_description>
  </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/NCT03266718
org study id: Pro00060926
nct id: NCT03266718
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This pilot study will develop and test a couple-based physical activity intervention among
      cancer survivors and their partners.

      Aim 1: To determine the feasibility and acceptability of a couple-based physical activity
      intervention for cancer survivors. Feasibility will be quantified using rates of study
      eligibility, overall accrual, attrition, and adherence to the study protocol. Acceptability
      will be assessed via couples' ratings on a standardized measure of treatment effectiveness/
      satisfaction, supplemented open-ended questions

      Aim 2: To provide preliminary data on the effects of a couple-based physical activity
      intervention relative to a wait list control group on survivor outcomes (i.e., level of
      physical activity, quality of life, self-efficacy for achieving and maintaining physical
      activity goals, perceived partner support for physical activity, and quality of the
      survivor-partner relationship). The investigators hypothesize that the intervention will
      produce benefits in each of these domains.

      Aim 3: To provide preliminary data on the effects of a couple-based physical activity
      intervention relative to a wait list control group on partner outcomes (i.e., partner's level
      of physical activity, self-efficacy for helping the survivor achieve and maintain physical
      activity goals, and quality of the survivor-partner relationship). The investigators
      hypothesize that the couple-based intervention will produce benefits in each of these
      domains.
Background and Significance:

      Physical activity (PA) is an essential part of cancer survivors' treatment plan as it helps
      prevent recurrence and improves cardiovascular fitness and downstream cardiovascular risk,
      the cause for most deaths in cancer survivors. Additional benefits of increasing PA include
      improvements in body composition, physical function, psychological outcomes, and quality of
      life. However, most survivors are not sufficiently active and would benefit from an
      intervention to promote PA. Prior PA interventions for cancer survivors have had mixed
      success. A recent systematic review identified 14 RCTs testing exercise interventions among
      sedentary cancer survivors and concluded that there was insufficient evidence that existing
      interventions are successful in achieving recommended levels of PA. In particular, there has
      been a lack of attention to psychosocial aspects of changing behavior, and to strategies that
      promote independent exercise behavior that can be maintained over time. Thus, it is clear
      that novel approaches to PA interventions are needed.

      Design:

      This is a two-arm randomized controlled trial to evaluate a couple-based physical activity
      (PA) intervention that systematically trains partners in skills to support the survivor in PA
      initiation and maintenance strategies.

      Couples randomized to Arm 1 (the Couples-Based Physical Activity Intervention) will receive
      four 60-minute intervention sessions via videoconference with Duke staff. Study staff will
      provide couples with instructions for use of the iPad computer (if provided by the study) and
      videoconference software which will be used to deliver the intervention sessions. Couples
      will also be provided with contact information for technical support. The first 3 sessions
      will be conducted weekly, with a booster session occurring approximately one month later. The
      intervention will include components to (a) encourage couples' favorable outcome expectations
      about the benefits of working together to initiate and maintain increases in PA, (b) build
      their confidence that they can work together to accomplish their goals, and (c) help them
      identify and use communal strategies, such as couple communication and joint decision making
      about goals and plans for increasing physical activity, and working through barriers to
      making these changes. Finally, the intervention will incorporate important behavior change
      techniques that have been found to help people change their exercise behavior, such as goal
      setting, self-monitoring of behavior, and prompts for practice, adapting them to a communal
      coping approach. Treatment sessions will be audio recorded for QA purposes.

      Those randomized to Arm 2 (waitlist control) will have the option to receive the intervention
      after they complete the follow-up survey. This version of the intervention will not include
      the booster session, so will last approximately 1 month in total. If they choose to receive
      the intervention, they will be provided with a tablet computer if they do not have one.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Feasibility of a couple-based physical activity intervention for cancer survivors as measured by a composite score of total number of couples screened and rates for non-eligibility.
time frame: 2 months after baseline survey
measure: Feasibility of a couple-based physical activity intervention for cancer survivors as measured by a composite score of total number of couples screened and rates of refusal.
time frame: 2 months after baseline survey
measure: Acceptability of a couple-based physical activity intervention for cancer survivors as measured by a composite score of total number of couples screened and rates for non-eligibility.
time frame: 2 months after baseline survey
measure: Acceptability of a couple-based physical activity intervention for cancer survivors as measured by a composite score of total number of couples screened and rates of refusal.
time frame: 2 months after baseline survey
measure: Efficacy as measured by steps taken
time frame: 2 months after baseline survey
measure: Quality of life as measured by surveys
time frame: 2 months after baseline survey
measure: Self -efficacy for achieving and maintaining physical activity goals as measured by surveys
time frame: 2 months after baseline survey
measure: Perceived partner support for physical activity as measured by surveys
time frame: 2 months after baseline survey
measure: Quality of the survivor-partner relationship as measured by surveys
time frame: 2 months after baseline survey
arm group label: Physical Activity Intervention
arm group type: Other
description: Couples will receive four 60-minute intervention sessions via videoconference with Duke staff. Study staff will provide couples with instructions for use of the iPad computer and videoconference software which will be used to deliver the intervention sessions.The first 3 sessions will be conducted weekly, with a booster session occurring approximately one month later.
arm group label: Waitlist control
arm group type: Other
description: Couples will have the option to receive the intervention after they complete the follow-up survey. This version of the intervention will not include the booster session, so will last approximately 1 month in total. If they choose to receive the intervention, they will be provided with a tablet computer if they do not have one.
intervention type: Behavioral
intervention name: Physical Activity Intervention
description: To develop and test a couple-based physical activity intervention among cancer survivors and their partners
arm group label: Physical Activity Intervention
arm group label: Waitlist control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Laura Porter, PhD
role: Principal Investigator
affiliation: Duke University
responsible party type: Sponsor
sharing ipd: No
ipd description: We will not share IPD unless requested by Duke Researchers only.