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

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

Study Overview

• Status: Completed
• Conditions: Ovarian Cancer
• Intervention / Treatment: Behavioral: Use of Purposeful app

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Rogel Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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)

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility assessed by enrollment rate	The number of patients who enroll in the study, of the total number of patients approached for enrollment.	At time of enrollment
Feasibility assessed by percentage of days of app use	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.	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	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	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)	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)	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)	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

• Sponsor: University of Michigan Rogel Cancer Center
• Collaborators: Rogel Cancer Center Cancer Control and Population Sciences O-SURE initiative
• Investigators: Principal Investigator: Celeste Leigh Pearce, PhD, MPH, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2021
• Primary Completion (Actual): December 10, 2022
• Study Completion (Actual): December 10, 2022

Study Registration Dates

• First Submitted: June 30, 2020
• First Submitted That Met QC Criteria: June 30, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): November 6, 2024
• Last Update Submitted That Met QC Criteria: November 4, 2024
• Last Verified: November 1, 2024

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: No
• Studies a U.S. FDA-regulated device product: No