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

NCT04458168 | Completed

• 2 other identifiers: UMCC 2018.153HUM00140226
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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".

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Change in life purpose from baseline

  6 months

• Change in quality of life assessed using Functional Assessment of Cancer Therapy-Ovarian (FACT-O) Trial Outcome Index (TOI) (FACT-O TOI)

  6 months

• Change in quality of life assessed using Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)

  6 months

• Change in quality of life using Comprehensive Measure of Meaning (Well-being questionnaire Part 10)

  6 months

Study Arms (3)

Recently completed treatment

EXPERIMENTAL

25 women who have just completed treatment

Behavioral: Use of Purposeful app

No recurrence of ovarian cancer for at least one year

EXPERIMENTAL

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

Recurrence of ovarian cancer

EXPERIMENTAL

25 women who have experienced a recurrence of their ovarian cancer after primary treatment

Behavioral: Use of Purposeful app

Interventions

Use of Purposeful app BEHAVIORAL

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.

No recurrence of ovarian cancer for at least one year; Recently completed treatment; Recurrence of ovarian cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• Rogel Cancer Center Cancer Control and Population Sciences O-SURE initiative: collaborator

Study Sites (1)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Celeste Leigh Pearce, PhD, MPH

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: July 7, 2020
• Study Start: June 28, 2021
• Primary Completion: December 10, 2022
• Study Completion: December 10, 2022
• Last Updated: November 6, 2024

Record last verified: 2024-11

Locations

US (1)