Clinical trial NCT04458168: Feasibility and Evaluation of a Self-care App to Enhance Purposeful Living
Official title: Feasibility and Evaluation of a Self-care App to Enhance Purposeful Living
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovarian Cancer
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
Collaborators: name: Rogel Cancer Center Cancer Control and Population Sciences O-SURE initiative
First posted: 2020-07-07
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Feasibility assessed by enrollment rate
timeFrame: At time of enrollment
measure: Feasibility assessed by percentage of days of app use
timeFrame: 6 months
measure: Feasibility assessed by trajectory of usage on a percent of days used on both a weekly and monthly time scale.
timeFrame: 6 months
measure: Acceptability assessed by percentage of patients who find the Purposeful app to be acceptable
timeFrame: 6 months
Secondary outcomes:
measure: Change in life purpose from baseline
timeFrame: 6 months
measure: Change in quality of life assessed using Functional Assessment of Cancer Therapy-Ovarian (FACT-O) Trial Outcome Index (TOI) (FACT-O TOI)
timeFrame: 6 months
measure: Change in quality of life assessed using Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
timeFrame: 6 months
measure: Change in quality of life using Comprehensive Measure of Meaning (Well-being questionnaire Part 10)
timeFrame: 6 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Rogel Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: Celeste Leigh Pearce, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: