NCT04604158CompletedNot Applicable
IIT2020-13-GRESHAM-ELLY: Evaluating the Effect of a Mobile Audio Companion (Elly) to Reduce Anxiety in Cancer Patients
Gillian Gresham1 site in 1 country38 target enrollmentStarted: December 2, 2020Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Absolute change in patient-reported anxiety scores at Day 30 compared with baseline.
Study Overview
Brief Summary
This is a single-arm, prospective, interventional study in cancer survivors and patients to examine the feasibility of a mobile health application, Elly (Elly Health Inc.), to reduce levels of anxiety, stress, loneliness, and social isolation. Participants will be given access to the Elly phone application developed by Elly Health Inc. and will be asked to complete questionnaires measuring quality of life at multiple timepoints during the study.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of cancer of any type and currently receiving cancer-targeted treatment or have received cancer-targeted treatment within 6 months of consent date based on self-report. Cancer-targeted treatment includes chemotherapy, radiation therapy, hormonal therapy, biologic therapy, immunotherapy, and surgery.
- •18 years or older
- •Access to and ability to use an iPhone (SE+, iOS 12.4+)
- •Ability to understand and read English
- •Have an understanding, ability, and willingness to fully comply with study procedures and restrictions
Exclusion Criteria
- •- Hearing loss or vision impairment that would preclude the participant from accessing and using the app (use of hearing aids or visual aids is acceptable) based on self-report.
Arms & Interventions
Elly Mobile Phone Application
Experimental
Intervention: Elly Mobile Phone Application (Behavioral)
Outcomes
Primary Outcomes
Absolute change in patient-reported anxiety scores at Day 30 compared with baseline.
Time Frame: 30 days
Absolute change in patient-reported anxiety scores as measures using the NIH (National Institutes of Health) PROMIS (Patient-Reported Outcomes Measurement Information System) questionnaire at Day 30 compared with baseline. The minimum value is 6 and maximum value is 30, and a lower score means a better outcome.
Secondary Outcomes
- Absolute change in patient-reported depression scores at Day 30 compared with baseline.(30 days)
- Absolute change in patient-reported anxiety scores at Day 90 compared with baseline.(90 days)
- Absolute change in patient-reported anxiety scores at Day 14 compared with baseline.(14 days)
- Absolute change in patient-reported anxiety scores at Day 60 compared with baseline.(60 days)
- Absolute change in patient-reported depression scores at Day 60 compared with baseline.(60 days)
- Absolute change in patient-reported loneliness scores at Day 30 compared with baseline.(30 days)
- Absolute change in patient-reported anxiety scores at Day 120 compared with baseline.(120 days)
- Absolute change in patient-reported anxiety scores at Day 150 compared with baseline.(150 days)
- Absolute change in patient-reported depression scores at Day 150 compared with baseline.(150 days)
- Absolute change in patient-reported loneliness scores at Day 120 compared with baseline.(120 days)
- Absolute change in patient-reported social isolation scores at Day 90 compared with baseline.(90 days)
- Absolute change in patient-reported social isolation scores at Day 180 compared with baseline.(180 days)
- Participant's experience with Elly app at Day 180-360.(Day 360)
- Absolute change in patient-reported anxiety scores at Day 180 compared with baseline.(180 days)
- Absolute change in patient-reported depression scores at Day 90 compared with baseline.(90 days)
- Absolute change in patient-reported depression scores at Day 120 compared with baseline.(120 days)
- Absolute change in patient-reported loneliness scores at Day 150 compared with baseline.(150 days)
- Absolute change in patient-reported social isolation scores at Day 60 compared with baseline.(60 days)
- Feasibility(180 days)
- Participant's experience with Elly app at Day 14-30.(Day 30)
- Absolute change in patient-reported depression scores at Day 180 compared with baseline.(180 days)
- Absolute change in patient-reported loneliness scores at Day 60 compared with baseline.(60 days)
- Absolute change in patient-reported loneliness scores at Day 90 compared with baseline.(90 days)
- Absolute change in patient-reported loneliness scores at Day 180 compared with baseline.(180 days)
- Absolute change in patient-reported social isolation scores at Day 120 compared with baseline.(120 days)
- Absolute change in patient-reported social isolation scores at Day 150 compared with baseline.(150 days)
- Elly app login amount (frequency and duration)(180 days)
- Absolute change in patient-reported social isolation scores at Day 30 compared with baseline.(30 days)
- Frequency of Elly app use(180 days)
Investigators
Gillian Gresham
Principal Investigator
Cedars-Sinai Medical Center
Study Sites (1)
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