Clinical trial NCT04604158: Evaluating the Effect of a Mobile Audio Companion (Elly) to Reduce Anxiety in Cancer Patients
Official title: IIT2020-13-GRESHAM-ELLY: Evaluating the Effect of a Mobile Audio Companion (Elly) to Reduce Anxiety in Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Cancer Metastatic
Neoplasms
Breast Cancer
Lung Cancer
Glioblastoma
Prostate Cancer
Gynecologic Cancer
Colorectal Cancer
Sarcoma
Kidney Cancer
Bladder Cancer
Lymphoma
Leukemia
Head and Neck Cancer
Pancreas Cancer
Multiple Myeloma
Anxiety
Social Isolation
Stress
Loneliness
Melanoma
Uterine Cancer
Keywords: Elly Health
Elly App
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2020-10-27
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Absolute change in patient-reported anxiety scores at Day 30 compared with baseline.
timeFrame: 30 days
Secondary outcomes:
measure: Absolute change in patient-reported anxiety scores at Day 14 compared with baseline.
timeFrame: 14 days
measure: Absolute change in patient-reported anxiety scores at Day 60 compared with baseline.
timeFrame: 60 days
measure: Absolute change in patient-reported anxiety scores at Day 90 compared with baseline.
timeFrame: 90 days
measure: Absolute change in patient-reported anxiety scores at Day 120 compared with baseline.
timeFrame: 120 days
measure: Absolute change in patient-reported anxiety scores at Day 150 compared with baseline.
timeFrame: 150 days
measure: Absolute change in patient-reported anxiety scores at Day 180 compared with baseline.
timeFrame: 180 days
measure: Absolute change in patient-reported depression scores at Day 30 compared with baseline.
timeFrame: 30 days
measure: Absolute change in patient-reported depression scores at Day 60 compared with baseline.
timeFrame: 60 days
measure: Absolute change in patient-reported depression scores at Day 90 compared with baseline.
timeFrame: 90 days
measure: Absolute change in patient-reported depression scores at Day 120 compared with baseline.
timeFrame: 120 days
measure: Absolute change in patient-reported depression scores at Day 150 compared with baseline.
timeFrame: 150 days
measure: Absolute change in patient-reported depression scores at Day 180 compared with baseline.
timeFrame: 180 days
measure: Absolute change in patient-reported loneliness scores at Day 30 compared with baseline.
timeFrame: 30 days
measure: Absolute change in patient-reported loneliness scores at Day 60 compared with baseline.
timeFrame: 60 days
measure: Absolute change in patient-reported loneliness scores at Day 90 compared with baseline.
timeFrame: 90 days
measure: Absolute change in patient-reported loneliness scores at Day 120 compared with baseline.
timeFrame: 120 days
measure: Absolute change in patient-reported loneliness scores at Day 150 compared with baseline.
timeFrame: 150 days
measure: Absolute change in patient-reported loneliness scores at Day 180 compared with baseline.
timeFrame: 180 days
measure: Absolute change in patient-reported social isolation scores at Day 30 compared with baseline.
timeFrame: 30 days
measure: Absolute change in patient-reported social isolation scores at Day 60 compared with baseline.
timeFrame: 60 days
measure: Absolute change in patient-reported social isolation scores at Day 90 compared with baseline.
timeFrame: 90 days
measure: Absolute change in patient-reported social isolation scores at Day 120 compared with baseline.
timeFrame: 120 days
measure: Absolute change in patient-reported social isolation scores at Day 150 compared with baseline.
timeFrame: 150 days
measure: Absolute change in patient-reported social isolation scores at Day 180 compared with baseline.
timeFrame: 180 days
measure: Frequency of Elly app use
timeFrame: 180 days
measure: Elly app login amount (frequency and duration)
timeFrame: 180 days
measure: Feasibility
timeFrame: 180 days
measure: Participant's experience with Elly app at Day 14-30.
timeFrame: Day 30
measure: Participant's experience with Elly app at Day 180-360.
timeFrame: Day 360
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Gillian Gresham, PhD
role: PRINCIPAL_INVESTIGATOR
References: