<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/NCT04458168</url>
  </required_header>
  <id_info>
    <org_study_id>UMCC 2018.153</org_study_id>
    <secondary_id>HUM00140226</secondary_id>
    <nct_id>NCT04458168</nct_id>
  </id_info>
  <brief_title>Feasibility and Evaluation of a Self-care App to Enhance Purposeful Living</brief_title>
  <official_title>Feasibility and Evaluation of a Self-care App to Enhance Purposeful Living</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan Rogel Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Rogel Cancer Center Cancer Control and Population Sciences O-SURE initiative</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Michigan Rogel Cancer Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this pilot study, ovarian cancer survivors will be enrolled and followed for six months to&#xD;
      evaluate usage of an eHealth app called &quot;Purposeful&quot;.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will determine the feasibility and acceptability of Purposeful, the eHealth app.&#xD;
      First, feasibility of enrolling ovarian cancer survivors to use Purposeful will be assessed.&#xD;
      Secondly, the acceptability of the app among ovarian cancer survivors will be assessed, based&#xD;
      on frequency of use and validated acceptability measures. Participants will be asked to&#xD;
      complete other validated questionnaires so investigators may explore whether further research&#xD;
      on the Purposeful app among ovarian cancer survivors is warranted. This will include&#xD;
      correlations between use of the Purposeful app and the life purpose questionnaire score.&#xD;
      Lastly, correlation between life purpose and quality of life in ovarian cancer survivors will&#xD;
      be explored.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 28, 2021</start_date>
  <completion_date type="Anticipated">April 2024</completion_date>
  <primary_completion_date type="Anticipated">April 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-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 assessed by enrollment rate</measure>
    <time_frame>At time of enrollment</time_frame>
    <description>The number of patients who enroll in the study, of the total number of patients approached for enrollment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility assessed by percentage of days of app use</measure>
    <time_frame>6 months</time_frame>
    <description>Percentage of days during a 6-month period on which each participant used the Purposeful app. Using the app during the day is defined as doing at least one of the following: setting an intention; completing a reflection; completing an action. Usage data will be provided by the Purposeful app.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility assessed by trajectory of usage on a percent of days used on both a weekly and monthly time scale.</measure>
    <time_frame>6 months</time_frame>
    <description>The average percentage of days of app use per week and per month during a 6-month period. Using the app during the day is defined as doing at least one of the following: setting an intention; completing a reflection; completing an action. Usage data will be provided by the Purposeful app.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability assessed by percentage of patients who find the Purposeful app to be acceptable</measure>
    <time_frame>6 months</time_frame>
    <description>A score of 3 or more on the acceptability summary score (assessed using a protocol-specific questionnaire) will indicate that the patient finds the Purposeful app to be acceptable.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in life purpose from baseline</measure>
    <time_frame>6 months</time_frame>
    <description>Assessed at baseline, 1, 3 and 6 months using the Modified Ryff and Keyes Scales of Psychological Well-being evaluation, a 7-item questionnaire that uses a Likert scale ranging from 1 to 6, with higher scores indicating greater purpose in life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life assessed using Functional Assessment of Cancer Therapy-Ovarian (FACT-O) Trial Outcome Index (TOI) (FACT-O TOI)</measure>
    <time_frame>6 months</time_frame>
    <description>Assessed at baseline, 1, 3 and 6 months. FACT-O TOI is a 26-item questionnaire that sums the physical well-being, functional well-being, and additional health concerns with a 7-day recall period. All items will be rated on a 5 items (point) Likert Scale, from 0 (not at all) to 4 (very much so). To score the FACT-O TOI, all 26 items will be summed to create a single score with a range from 0 to 104. Items will be reverse scored when appropriate to provide a scale in which a higher score represent a higher quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life assessed using Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)</measure>
    <time_frame>6 months</time_frame>
    <description>Assessed at baseline, 1, 3 and 6 months. The FACIT-fatigue scale is a 13-item patient-reported measure of fatigue with a 7-day recall period. All items will be rated on a 5 items (point) Likert Scale, from 0 (not at all) to 4 (very much so). To score the FACIT-fatigue, all 13 items will be summed to create a single fatigue score with a range from 0 to 52. Items will be reverse scored when appropriate to provide a scale in which a higher score represent less fatigue.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life using Comprehensive Measure of Meaning (Well-being questionnaire Part 10)</measure>
    <time_frame>6 months</time_frame>
    <description>Assessed at baseline, 1, 3 and 6 months. The Comprehensive Measure of Meaning (Well-being questionnaire Part 10) is a 21-item questionnaire that uses a Likert scale ranging from 1 to 7, with higher scores indicating greater well-being.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Ovarian Cancer</condition>
  <arm_group>
    <arm_group_label>Recently completed treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>25 women who have just completed treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No recurrence of ovarian cancer for at least one year</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>25 women who have not experienced a recurrence of their ovarian cancer at least one year after their initial diagnosis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Recurrence of ovarian cancer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>25 women who have experienced a recurrence of their ovarian cancer after primary treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Use of Purposeful app</intervention_name>
    <description>Patients will be asked to use the Purposeful app every day, which should take no longer than 5 minutes. The app includes three key components: Explore, Act and Reflect. The Explore section provides thematically organized resources that suggest discrete actions users can try out and potentially incorporate into their lives. The app uses machine learning to customize resources presented to the user. The Act section is where users place actions they'd like to keep track of or build into a habit. Finally, the Reflect section includes daily &quot;reflections&quot; where the patient answers open ended questions regarding their alignment with their best self qualities, their sense of purpose, and more. Depending on whether users choose to allow push notifications, they will be notified daily to complete morning, afternoon, and/or evening reflections.&#xD;
Participants will complete questionnaires at enrollment and at 1, 3, and 6 months after enrollment.</description>
    <arm_group_label>No recurrence of ovarian cancer for at least one year</arm_group_label>
    <arm_group_label>Recently completed treatment</arm_group_label>
    <arm_group_label>Recurrence of ovarian cancer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of ovarian cancer or treatment for ovarian cancer through the University of&#xD;
             Michigan Gynecologic Oncology service&#xD;
&#xD;
          -  Completed primary treatment (either surgery alone or surgery + chemotherapy)&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent&#xD;
&#xD;
          -  Ability to speak and read English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  There are no additional exclusion criteria for participation in this study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Celeste Leigh Pearce, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Michigan Rogel Cancer Center</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>October 6, 2022</last_update_submitted>
  <last_update_submitted_qc>October 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT04458168
org study id: UMCC 2018.153
secondary id: HUM00140226
nct id: NCT04458168
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
In this pilot study, ovarian cancer survivors will be enrolled and followed for six months to
      evaluate usage of an eHealth app called "Purposeful".
This study will determine the feasibility and acceptability of Purposeful, the eHealth app.
      First, feasibility of enrolling ovarian cancer survivors to use Purposeful will be assessed.
      Secondly, the acceptability of the app among ovarian cancer survivors will be assessed, based
      on frequency of use and validated acceptability measures. Participants will be asked to
      complete other validated questionnaires so investigators may explore whether further research
      on the Purposeful app among ovarian cancer survivors is warranted. This will include
      correlations between use of the Purposeful app and the life purpose questionnaire score.
      Lastly, correlation between life purpose and quality of life in ovarian cancer survivors will
      be explored.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Feasibility assessed by enrollment rate
time frame: At time of enrollment
description: The number of patients who enroll in the study, of the total number of patients approached for enrollment.
measure: Feasibility assessed by percentage of days of app use
time frame: 6 months
description: Percentage of days during a 6-month period on which each participant used the Purposeful app. Using the app during the day is defined as doing at least one of the following: setting an intention; completing a reflection; completing an action. Usage data will be provided by the Purposeful app.
measure: Feasibility assessed by trajectory of usage on a percent of days used on both a weekly and monthly time scale.
time frame: 6 months
description: The average percentage of days of app use per week and per month during a 6-month period. Using the app during the day is defined as doing at least one of the following: setting an intention; completing a reflection; completing an action. Usage data will be provided by the Purposeful app.
measure: Acceptability assessed by percentage of patients who find the Purposeful app to be acceptable
time frame: 6 months
description: A score of 3 or more on the acceptability summary score (assessed using a protocol-specific questionnaire) will indicate that the patient finds the Purposeful app to be acceptable.
measure: Change in life purpose from baseline
time frame: 6 months
description: Assessed at baseline, 1, 3 and 6 months using the Modified Ryff and Keyes Scales of Psychological Well-being evaluation, a 7-item questionnaire that uses a Likert scale ranging from 1 to 6, with higher scores indicating greater purpose in life.
measure: Change in quality of life assessed using Functional Assessment of Cancer Therapy-Ovarian (FACT-O) Trial Outcome Index (TOI) (FACT-O TOI)
time frame: 6 months
description: Assessed at baseline, 1, 3 and 6 months. FACT-O TOI is a 26-item questionnaire that sums the physical well-being, functional well-being, and additional health concerns with a 7-day recall period. All items will be rated on a 5 items (point) Likert Scale, from 0 (not at all) to 4 (very much so). To score the FACT-O TOI, all 26 items will be summed to create a single score with a range from 0 to 104. Items will be reverse scored when appropriate to provide a scale in which a higher score represent a higher quality of life.
measure: Change in quality of life assessed using Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
time frame: 6 months
description: Assessed at baseline, 1, 3 and 6 months. The FACIT-fatigue scale is a 13-item patient-reported measure of fatigue with a 7-day recall period. All items will be rated on a 5 items (point) Likert Scale, from 0 (not at all) to 4 (very much so). To score the FACIT-fatigue, all 13 items will be summed to create a single fatigue score with a range from 0 to 52. Items will be reverse scored when appropriate to provide a scale in which a higher score represent less fatigue.
measure: Change in quality of life using Comprehensive Measure of Meaning (Well-being questionnaire Part 10)
time frame: 6 months
description: Assessed at baseline, 1, 3 and 6 months. The Comprehensive Measure of Meaning (Well-being questionnaire Part 10) is a 21-item questionnaire that uses a Likert scale ranging from 1 to 7, with higher scores indicating greater well-being.
arm group label: Recently completed treatment
arm group type: Experimental
description: 25 women who have just completed treatment
arm group label: No recurrence of ovarian cancer for at least one year
arm group type: Experimental
description: 25 women who have not experienced a recurrence of their ovarian cancer at least one year after their initial diagnosis
arm group label: Recurrence of ovarian cancer
arm group type: Experimental
description: 25 women who have experienced a recurrence of their ovarian cancer after primary treatment
intervention type: Behavioral
intervention name: Use of Purposeful app
description: Patients will be asked to use the Purposeful app every day, which should take no longer than 5 minutes. The app includes three key components: Explore, Act and Reflect. The Explore section provides thematically organized resources that suggest discrete actions users can try out and potentially incorporate into their lives. The app uses machine learning to customize resources presented to the user. The Act section is where users place actions they'd like to keep track of or build into a habit. Finally, the Reflect section includes daily "reflections" where the patient answers open ended questions regarding their alignment with their best self qualities, their sense of purpose, and more. Depending on whether users choose to allow push notifications, they will be notified daily to complete morning, afternoon, and/or evening reflections.
Participants will complete questionnaires at enrollment and at 1, 3, and 6 months after enrollment.
arm group label: No recurrence of ovarian cancer for at least one year
arm group label: Recently completed treatment
arm group label: Recurrence of ovarian cancer
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Celeste Leigh Pearce, PhD, MPH
role: Principal Investigator
affiliation: University of Michigan
facility: 
country: United States
responsible party type: Sponsor