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Clinical Trials/NCT04458168
NCT04458168
Completed
N/A

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

University of Michigan Rogel Cancer Center1 site in 1 country120 target enrollmentJune 28, 2021
ConditionsOvarian Cancer

Overview

Phase
N/A
Intervention
Not specified
Conditions
Ovarian Cancer
Sponsor
University of Michigan Rogel Cancer Center
Enrollment
120
Locations
1
Primary Endpoint
Feasibility assessed by enrollment rate
Status
Completed
Last Updated
last year

Overview

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".

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.

Registry
clinicaltrials.gov
Start Date
June 28, 2021
End Date
December 10, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

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.

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.

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.

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 Outcomes

  • 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 life purpose from baseline(6 months)
  • Change in quality of life using Comprehensive Measure of Meaning (Well-being questionnaire Part 10)(6 months)
  • Change in quality of life assessed using Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)(6 months)

Study Sites (1)

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