Feasibility and Evaluation of a Self-care App to Enhance Purposeful Living
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan Rogel Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Recently completed treatment
25 women who have just completed treatment
|
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
|
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
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
At time of enrollment
|
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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.
|
6 months
|
|
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.
|
6 months
|
|
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.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
6 months
|
|
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.
|
6 months
|
|
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.
|
6 months
|
|
Change in quality of life using Comprehensive Measure of Meaning (Well-being questionnaire Part 10)
Time Frame: 6 months
|
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.
|
6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Celeste Leigh Pearce, PhD, MPH, University of Michigan
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- UMCC 2018.153
- HUM00140226 (Other Identifier: University of Michigan)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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