Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Feasibility and Evaluation of a Self-care App to Enhance Purposeful Living

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04458168
Recruitment Status : Not yet recruiting
First Posted : July 7, 2020
Last Update Posted : July 7, 2020
Sponsor:
Collaborator:
Rogel Cancer Center Cancer Control and Population Sciences O-SURE initiative
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

Brief Summary:
In this pilot study, ovarian cancer survivors will be enrolled and followed for six months to evaluate usage of an eHealth app called "Purposeful".

Condition or disease Intervention/treatment Phase
Ovarian Cancer Behavioral: Use of Purposeful app Not Applicable

Detailed Description:
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Feasibility and Evaluation of a Self-care App to Enhance Purposeful Living
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
Experimental: Recently completed treatment
25 women who have just completed treatment
Behavioral: Use of Purposeful app

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.


Experimental: No recurrence of ovarian cancer for at least one year
25 women who have not experienced a recurrence of their ovarian cancer at least one year after their initial diagnosis
Behavioral: Use of Purposeful app

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.


Experimental: Recurrence of ovarian cancer
25 women who have experienced a recurrence of their ovarian cancer after primary treatment
Behavioral: Use of Purposeful app

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.





Primary Outcome Measures :
  1. Feasibility assessed by enrollment rate [ Time Frame: At time of enrollment ]
    The number of patients who enroll in the study, of the total number of patients approached for enrollment.

  2. Feasibility assessed by percentage of days of app use [ Time Frame: 6 months ]
    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.

  3. Feasibility assessed by trajectory of usage on a percent of days used on both a weekly and monthly time scale. [ Time Frame: 6 months ]
    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.

  4. Acceptability assessed by percentage of patients who find the Purposeful app to be acceptable [ Time Frame: 6 months ]
    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.


Secondary Outcome Measures :
  1. Change in life purpose from baseline [ Time Frame: 6 months ]
    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.

  2. 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 ]
    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.

  3. Change in quality of life assessed using Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) [ Time Frame: 6 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of ovarian cancer or treatment for ovarian cancer through the University of Michigan Gynecologic Oncology service
  • Completed primary treatment (either surgery alone or surgery + chemotherapy)
  • Ability to understand and the willingness to sign a written informed consent
  • Ability to speak and read English

Exclusion Criteria:

  • There are no additional exclusion criteria for participation in this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04458168


Contacts
Layout table for location contacts
Contact: Cancer AnswerLine 1-800-865-1125 CancerAnswerLine@med.umich.edu

Locations
Layout table for location information
United States, Michigan
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States, 48109
Principal Investigator: Celeste Leigh Pearce, PhD, MPH         
Sponsors and Collaborators
University of Michigan Rogel Cancer Center
Rogel Cancer Center Cancer Control and Population Sciences O-SURE initiative
Investigators
Layout table for investigator information
Principal Investigator: Celeste Leigh Pearce, PhD, MPH University of Michigan
Layout table for additonal information
Responsible Party: University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT04458168    
Other Study ID Numbers: UMCC 2018.153
HUM00140226 ( Other Identifier: University of Michigan )
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: June 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No