<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/NCT03233334</url>
  </required_header>
  <id_info>
    <org_study_id>CKMR-1702</org_study_id>
    <nct_id>NCT03233334</nct_id>
  </id_info>
  <brief_title>Purpose Project: Reclaiming Life Purpose After Breast Cancer (Feasibility Study)</brief_title>
  <official_title>Purpose Project: Reclaiming Life Purpose After Breast Cancer (Feasibility Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Allina Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Allina Health System</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>
      The Purpose Project intervention is an 8-session progressive structure that was developed&#xD;
      based on theoretical and scientific evidence from psychology and occupational therapy. The&#xD;
      goal of the intervention is to provide participants with information, tools, and support that&#xD;
      help them move towards reclaiming a sense of self-grounded purpose in daily life. The study&#xD;
      will use a convenience sample of women with breast cancer to evaluate the feasibility of the&#xD;
      Purpose Project intervention in terms of demand/acceptability, implementation, and&#xD;
      limited-efficacy testing. Findings will be used to inform a later study to evaluate the&#xD;
      efficacy of the Purpose Project intervention.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">January 31, 2019</completion_date>
  <primary_completion_date type="Actual">August 1, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</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 psychological well-being</measure>
    <time_frame>Will be administered at Week 0 (pre-testing) and at Week 12 (session 8).</time_frame>
    <description>Using the Psychological Scales of Wellbeing questionnaire (Ryff, 1989; Ryff, &amp; Keyes, 1995), psychological wellbeing pre- and post- intervention will be tracked.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Recruitment</measure>
    <time_frame>Up to 1 month after IRB approval</time_frame>
    <description>Number of prospective participants approached by clinicians and number of self-referred prospective participants who contact PI or Study Coordinator with inquiries about the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of pre-testing session</measure>
    <time_frame>Duration of pre-testing session (approximately 2 hours) at week 0 to week 1</time_frame>
    <description>Actual length (in minutes) of pre-testing session.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of testing session</measure>
    <time_frame>Each week from week 2 through week 8, approximately 2.5 hours at each session</time_frame>
    <description>Actual length (in minutes) of testing session.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of post-testing session</measure>
    <time_frame>Duration of session 8 (at week 12), approximately 2 hours</time_frame>
    <description>Actual length (in minutes) of testing session.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Homework completion</measure>
    <time_frame>Each week from week 2 through week 8</time_frame>
    <description>Whether or not homework was attempted</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intervention fidelity</measure>
    <time_frame>Each week from week 2 through week 8</time_frame>
    <description>Which key intervention elements were provided during a given session</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Meaning in life</measure>
    <time_frame>At week 0 and at week 12</time_frame>
    <description>Meaning in Life Questionnaire (Steger et al., 2006): A 10-item questionnaire designed to measure 2 dimensions of meaning in life: Presence of Meaning (how much respondents feel their lives have meaning) and Search for Meaning (how much respondents strive to find meaning and understanding in their lives).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Satisfaction with Participation in Discretionary Social Activities</measure>
    <time_frame>At week 0 and at week 12</time_frame>
    <description>Satisfaction with Participation in Discretionary Social Activities (Hahn et al., 2010): Self-report questionnaires in which participants rated their level of satisfaction (1-5 scale) with social roles (14 items) and discretionary activities (12 items).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Engagement in Meaningful Activities</measure>
    <time_frame>At week 0 and at week 12</time_frame>
    <description>Engagement in Meaningful Activities Survey (Eakman, 2010):A 12-item self-report questionnaire designed to measure the extent to which a person experiences meaningfulness in his/her daily life activities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Purpose Status and Expectations</measure>
    <time_frame>At Week 12</time_frame>
    <description>A 2-question self-report developed by the study team to better understand what participants' hope to gain during the study and perceived changes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant Experience of Purpose Project</measure>
    <time_frame>At week 12 and at week 14-20</time_frame>
    <description>Participant experience of purpose project as measured by self-report questionnaire and post-intervention interview.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Purpose Project Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group receiving Purpose Project intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Purpose Project</intervention_name>
    <description>The purpose project intervention 8-session group intervention that integrates education, support, self-reflection, and action-expectation to help people reaffirm or reconstruct self-grounded purpose after significant life events/transitions. The 8 sessions extend over 2-3 months, with 7 weekly sessions and the final session 1 month after Session 7. The intervention is structured around the 6 dimensions of flourishing (autonomy, self-acceptance, personal growth, relationships, purpose in life, external mastery), the goal of which is to help people enact behaviors that move them forward in reframing a sense of self and reaffirming or reconstructing a sense of purpose in life that helps them flourish.</description>
    <arm_group_label>Purpose Project Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Between 25 and 74 years of age&#xD;
&#xD;
          2. Completed chemotherapy and/or radiation treatment for Stage 1, 2, or 3 breast cancer&#xD;
             up to 5 years prior to study enrollment&#xD;
&#xD;
          3. English speaking&#xD;
&#xD;
          4. Graduated from high school&#xD;
&#xD;
          5. Able to see, hear, speak (with or without assistive devices)&#xD;
&#xD;
          6. Able to provide own transportation to sessions&#xD;
&#xD;
          7. Willing and able to commit to attend all 8 intervention sessions, 2 testing sessions,&#xD;
             and the one-to-one interview that occurs after completing the 8 intervention sessions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Stage 4 breast cancer or any other stage 4 cancer&#xD;
&#xD;
          2. Actively receiving chemotherapy or radiation treatments for cancer. (However, patients&#xD;
             may be on Herceptin and/or endocrine treatment and participate in the study.)&#xD;
&#xD;
          3. History of neurologic disorder (such as stroke or brain injury) with residual&#xD;
             impairments that likely interfere with learning&#xD;
&#xD;
          4. Any medical condition (physical or mental health) that interferes with the performance&#xD;
             of everyday activities and roles.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>74 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mary Radomski, PhD, OTR/L</last_name>
    <role>Principal Investigator</role>
    <affiliation>Allina Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Abbott Northwestern Hospital</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>July 1, 2019</last_update_submitted>
  <last_update_submitted_qc>July 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Allina Health System</investigator_affiliation>
    <investigator_full_name>Mary Radomski</investigator_full_name>
    <investigator_title>Senior Scientific Advisor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <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/NCT03233334
org study id: CKMR-1702
nct id: NCT03233334
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The Purpose Project intervention is an 8-session progressive structure that was developed
      based on theoretical and scientific evidence from psychology and occupational therapy. The
      goal of the intervention is to provide participants with information, tools, and support that
      help them move towards reclaiming a sense of self-grounded purpose in daily life. The study
      will use a convenience sample of women with breast cancer to evaluate the feasibility of the
      Purpose Project intervention in terms of demand/acceptability, implementation, and
      limited-efficacy testing. Findings will be used to inform a later study to evaluate the
      efficacy of the Purpose Project intervention.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in psychological well-being
time frame: Will be administered at Week 0 (pre-testing) and at Week 12 (session 8).
description: Using the Psychological Scales of Wellbeing questionnaire (Ryff, 1989; Ryff, & Keyes, 1995), psychological wellbeing pre- and post- intervention will be tracked.
measure: Recruitment
time frame: Up to 1 month after IRB approval
description: Number of prospective participants approached by clinicians and number of self-referred prospective participants who contact PI or Study Coordinator with inquiries about the study
measure: Time of pre-testing session
time frame: Duration of pre-testing session (approximately 2 hours) at week 0 to week 1
description: Actual length (in minutes) of pre-testing session.
measure: Time of testing session
time frame: Each week from week 2 through week 8, approximately 2.5 hours at each session
description: Actual length (in minutes) of testing session.
measure: Time of post-testing session
time frame: Duration of session 8 (at week 12), approximately 2 hours
description: Actual length (in minutes) of testing session.
measure: Homework completion
time frame: Each week from week 2 through week 8
description: Whether or not homework was attempted
measure: Intervention fidelity
time frame: Each week from week 2 through week 8
description: Which key intervention elements were provided during a given session
measure: Change in Meaning in life
time frame: At week 0 and at week 12
description: Meaning in Life Questionnaire (Steger et al., 2006): A 10-item questionnaire designed to measure 2 dimensions of meaning in life: Presence of Meaning (how much respondents feel their lives have meaning) and Search for Meaning (how much respondents strive to find meaning and understanding in their lives).
measure: Change in Satisfaction with Participation in Discretionary Social Activities
time frame: At week 0 and at week 12
description: Satisfaction with Participation in Discretionary Social Activities (Hahn et al., 2010): Self-report questionnaires in which participants rated their level of satisfaction (1-5 scale) with social roles (14 items) and discretionary activities (12 items).
measure: Engagement in Meaningful Activities
time frame: At week 0 and at week 12
description: Engagement in Meaningful Activities Survey (Eakman, 2010):A 12-item self-report questionnaire designed to measure the extent to which a person experiences meaningfulness in his/her daily life activities.
measure: Purpose Status and Expectations
time frame: At Week 12
description: A 2-question self-report developed by the study team to better understand what participants' hope to gain during the study and perceived changes.
measure: Participant Experience of Purpose Project
time frame: At week 12 and at week 14-20
description: Participant experience of purpose project as measured by self-report questionnaire and post-intervention interview.
arm group label: Purpose Project Group
arm group type: Experimental
description: Group receiving Purpose Project intervention.
intervention type: Behavioral
intervention name: Purpose Project
description: The purpose project intervention 8-session group intervention that integrates education, support, self-reflection, and action-expectation to help people reaffirm or reconstruct self-grounded purpose after significant life events/transitions. The 8 sessions extend over 2-3 months, with 7 weekly sessions and the final session 1 month after Session 7. The intervention is structured around the 6 dimensions of flourishing (autonomy, self-acceptance, personal growth, relationships, purpose in life, external mastery), the goal of which is to help people enact behaviors that move them forward in reframing a sense of self and reaffirming or reconstructing a sense of purpose in life that helps them flourish.
arm group label: Purpose Project Group
criteria: 
gender: Female
minimum age: 25 Years
maximum age: 74 Years
healthy volunteers: No
last name: Mary Radomski, PhD, OTR/L
role: Principal Investigator
affiliation: Allina Health
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Allina Health System
investigator full name: Mary Radomski
investigator title: Senior Scientific Advisor
mesh term: Breast Neoplasms
sharing ipd: No